Duke University
CLINICAL RESEARCH COORDINATOR, SR
Duke University, Durham, North Carolina, United States, 27703
School of Medicine
Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.
This position is based out of Hock Plaza and requires a minimum of four days per week in person.
Occupational Summary
The Clinical Research CoordinatorSr. (CRC Sr.) will develop, coordinate and manage clinical research studies conducted by principal investigators affiliated with the Duke Center for Aging and Department of Neurology. The CRC Sr. will join a research team that is conducting a variety of studies on Alzheimer's Disease and related neurocognitive disorders. This position will involve working with collaborators at multiple sites and may require travel between clinics and offsite locations. The CRC Sr. will lead the day-to-day operations of multiple study teams conducting clinical research and provide oversight of CRCs and other research staff as the research portfolio of the team expands.
Preferred Qualifications:
Excellent verbal and written communication skills. Experience in training and overseeing others in study processes. Ability to oversee multiple personnel and studies. Recruitment and retention expertise. Experience or willingness to learn the administration of neuropsychological test battery and questionnaires with older adults as part of an evaluation for cognition.
Work Performed:
Research Operations
1. Serves as an expert resource to multiple study teams about regulatory and institutional policies and processes.
2. Screen participants for all studies, including those that are complex in nature (e.g., procedural and interventional studies).
3. Provides oversight and training for screening activities to multiple study teams.
4. Serves as an expert resource for multiple study teams for participant retention and liaises with other resources at Duk e to optimize retention rates.
5. For multiple study teams, develops and oversees the implementation of strategies for meeting recruitment goals; provides training.
6. Develops, oversees adherence, and trains multiple study teams in the use and development of standard operating procedures (SOPs).
7. Maintains study-level documentation for all studies, including those that are complex in nature.
8. Provides oversight, training, and expertise to multiple study teams regarding study level and participant level documentation for all studies including those that are complex in nature and/or require Duke University Health System (DUHS) billing.
9. Serves as an expert resource and trainer to multiple study teams for preparing and conducting complex study visits, developing tools, and implementing operational plans.
10. Provides direction to prepare for study monitoring and audit visits.
11. Creates, optimizes, and oversees the systems used by multiple teams to manage research specimens. Serves as expert resource and trainer to multiple study teams in specimen collection, processing, preparation, shipping, and maintenance.
12. For complex scenarios, recognize when agreements are necessary within the research program. Facilitates the process by coordinating with study teams and appropriate Duke offices.
13. Leads team meetings and facilitates healthy communication between staff. Ensures good communication across multiple study teams, and mentors staff to improve communication strategies.
Safety and Ethics
1. Ensures that multiple study teams/research program team members are appropriately identifying and documenting adverse event information.
2. Provides oversight and training to multiple study teams/research program team members who conduct and document consent for participants for all types of studies, including those that are complex in nature an d/or require any orders in Maestro Care. May serve as an expert resource with regard to conducting and documenting consent including liaising with and being knowledgeable about other resources at Duke. Provides oversight and training to multiple study teams/research program team members who develop the consent plan and document. Serves as an expert resource with regard to developing consent plans and documents for participants in a variety of studies.
3. Provides oversight and training to multiple study teams/research program team members who develop and submit documentation and information for IRB review.
4. Provides oversight and training to multiple study teams/research program team members who prepare and submit documents needed for regulatory and safety reporting to sponsors and other agencies.
Data
1. For multiple study teams, select data capture methods and discuss the advantages and disadvantages of each. Implements data capture methods at the unit, division, or departmental level. Independently designs ECRFs and EDCs to collect data according to protocol.
2. Oversees the process of QA, data corrections, and queries used within multiple study teams/the research program, including creating and using Q A protocols, queries, summaries, and reports. Recognizes trends, and recommends strategies to improve processes or retrain staff. Serves as an expert in data corrections, queries, and quality assurance resources, including liaising with and being knowledgeable about other related resources at Duke.
3. Develop and implement protocols for research programs that include strategies and processes to ensure data security and provenance. Serves as an expert data provenance and security resource, including liaising with and being knowledgeable about other related resources at Duke. Serves as an expert resource to mu ltiplestudy teams/research program with regard to mapping data flow. Predicts areas of vulnerability in the data flow plan. Determines areas where data provenance may be compromised, and helps study teams/research program staff work through solutions. Ensures that study teams are familiar with data flow resources at Duke. Seeks out, integrates, and applies new technical knowledge towards innovation and performance improvement for multiple research teams/research program, as relevant.
Science
1. Assists with or contributes to the development of funding proposals.
2. Independently reviews articles, synthesizes the literature, and uses to assist in the development of manuscripts or grant proposals.
3. Independently develops protocols for complex investigator-initiated studies, across multiple PIs or study teams.
4. Uses expertise in research design to provide significant contribution to protocols or research proposals.
5. Provides significant contribution or leadership on accepted, peer-reviewed publication or conferenc e presentation.
6. Mentors others in this area.
Study and Site Management
1. Mentors, trains, and oversees activities related to how teams communicate with sponsors and/or CROs. Oversees activities related to site visits.
2. Oversees use of systems and system reports to manage research participants' activities and track/mark financial milestones. Overseesuse of systems and system reports to manage research protocol activities and maintaining current protocol information.
3. Makes feasibility recommendations for multiple study teams/research programs. Develops and oversees processes to determine participa tion in trials.
4. Oversees management of resources (staff, supp lies, equipment) for multiple study teams/research program. May manage the budget for research studies.
5. For multiple study teams, ensures that studies are conducted in compliance with institut ional requirements and other policies.
6. Oversees implementation of operational plans across research programs, including at multiple sites.
7. Works with the CRU or departmental leadership to ensure that studies are closed according to best practices and guidelines.
Leadership
1. Encourages staff to take part in professional development opportunities. Provides opportunities for staff to attend key external offerings ( i.e. Research Wednesday, RPN, events outside of Duke, etc.).
2. Plays key role on committees and workgroups. Demonstrates interpersonal skillsto get work done efficiently. Recognizes and escalates organizational issues that could be optimized to improve research process. Actively facilitates and leads multiple study team's adoption of change in their working environment.
3. Uses advanced subject ma tter expertise in the therapeutic area or clinical research to solve pro blems across multiple study teams.
4. Trains others to communica te effectively within teams.
5. Facilitates resolution of issues associated with teams or communication.
6. Communicates effecti vely with others, regardless of reporting relationship, to accomplish sh ared work objectives.
REPORTING RELATIONSHIP: This position will report to the Department of Medicine CRU RPM. There will be dotted line reporting to the project-specific PI for scientific/project oversight. There may be an additional oversight relationship with study staff in other departments as needed.
Required Qualifications
Education/Training:
Completion of an Associate'sdegree is required. A Bache lor's degree is preferred.
Experience:
Work requires a minimum of six years of relevant research experience. A Bachelor's degree may substitute for 2 years of required experience.
Preferred Skills:
The ideal candidate will:• Possess excellent verbal and written communication skills• Possess human subject clinical research and regulatory experience• Showcase their proven ability to work both independently and within a team with excellence, dignity, and respect• Possess effective recruitment skills and comfort screening the medical record for suitability for the study• Display the ability to build longitudinal relationships with participants to ensure retention• Embody ability to manage and oversee several projects and personnel• Maintain familiarity with regulatory matters and IRB submissions and revisions• Oversee and participate in data collection and keeping accurate written and electronic records• Demonstrate flexibility and willingness to acquire new skills as the study expands• Direct the expansion of existing projects• Demonstrate the ability to plan and prioritize workload to meet deadlines, while planning and tracking the status of several projects• Exhibit familiarity or ease communicating and relating to older adults with mild Alzheimer's disease or other types of cognitive issues• Have experience with or willingness to learn the administration of neuropsychological test batteries and questionnaires with older adults as part of an evaluation for cognition• Demonstrate ability to oversee multiple personnel and students, and to train others in study processes• Demonstrate expertise in recruitment and retention of study participants• Experience with Maestro Care and OnCore preferred• Phlebotomy experience preferred
The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.
Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunities without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.
Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.
Essential Physical Job Functions
Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.
Minimum Qualifications
Education
Work requires an Associate's degree
Experience
Work requires a minimum of six years of research experience. A Bachelor's degree may substitute for 2 years of required experience.
Duke is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.
Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas-an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.
Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essentialjob functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.
Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.
This position is based out of Hock Plaza and requires a minimum of four days per week in person.
Occupational Summary
The Clinical Research CoordinatorSr. (CRC Sr.) will develop, coordinate and manage clinical research studies conducted by principal investigators affiliated with the Duke Center for Aging and Department of Neurology. The CRC Sr. will join a research team that is conducting a variety of studies on Alzheimer's Disease and related neurocognitive disorders. This position will involve working with collaborators at multiple sites and may require travel between clinics and offsite locations. The CRC Sr. will lead the day-to-day operations of multiple study teams conducting clinical research and provide oversight of CRCs and other research staff as the research portfolio of the team expands.
Preferred Qualifications:
Excellent verbal and written communication skills. Experience in training and overseeing others in study processes. Ability to oversee multiple personnel and studies. Recruitment and retention expertise. Experience or willingness to learn the administration of neuropsychological test battery and questionnaires with older adults as part of an evaluation for cognition.
Work Performed:
Research Operations
1. Serves as an expert resource to multiple study teams about regulatory and institutional policies and processes.
2. Screen participants for all studies, including those that are complex in nature (e.g., procedural and interventional studies).
3. Provides oversight and training for screening activities to multiple study teams.
4. Serves as an expert resource for multiple study teams for participant retention and liaises with other resources at Duk e to optimize retention rates.
5. For multiple study teams, develops and oversees the implementation of strategies for meeting recruitment goals; provides training.
6. Develops, oversees adherence, and trains multiple study teams in the use and development of standard operating procedures (SOPs).
7. Maintains study-level documentation for all studies, including those that are complex in nature.
8. Provides oversight, training, and expertise to multiple study teams regarding study level and participant level documentation for all studies including those that are complex in nature and/or require Duke University Health System (DUHS) billing.
9. Serves as an expert resource and trainer to multiple study teams for preparing and conducting complex study visits, developing tools, and implementing operational plans.
10. Provides direction to prepare for study monitoring and audit visits.
11. Creates, optimizes, and oversees the systems used by multiple teams to manage research specimens. Serves as expert resource and trainer to multiple study teams in specimen collection, processing, preparation, shipping, and maintenance.
12. For complex scenarios, recognize when agreements are necessary within the research program. Facilitates the process by coordinating with study teams and appropriate Duke offices.
13. Leads team meetings and facilitates healthy communication between staff. Ensures good communication across multiple study teams, and mentors staff to improve communication strategies.
Safety and Ethics
1. Ensures that multiple study teams/research program team members are appropriately identifying and documenting adverse event information.
2. Provides oversight and training to multiple study teams/research program team members who conduct and document consent for participants for all types of studies, including those that are complex in nature an d/or require any orders in Maestro Care. May serve as an expert resource with regard to conducting and documenting consent including liaising with and being knowledgeable about other resources at Duke. Provides oversight and training to multiple study teams/research program team members who develop the consent plan and document. Serves as an expert resource with regard to developing consent plans and documents for participants in a variety of studies.
3. Provides oversight and training to multiple study teams/research program team members who develop and submit documentation and information for IRB review.
4. Provides oversight and training to multiple study teams/research program team members who prepare and submit documents needed for regulatory and safety reporting to sponsors and other agencies.
Data
1. For multiple study teams, select data capture methods and discuss the advantages and disadvantages of each. Implements data capture methods at the unit, division, or departmental level. Independently designs ECRFs and EDCs to collect data according to protocol.
2. Oversees the process of QA, data corrections, and queries used within multiple study teams/the research program, including creating and using Q A protocols, queries, summaries, and reports. Recognizes trends, and recommends strategies to improve processes or retrain staff. Serves as an expert in data corrections, queries, and quality assurance resources, including liaising with and being knowledgeable about other related resources at Duke.
3. Develop and implement protocols for research programs that include strategies and processes to ensure data security and provenance. Serves as an expert data provenance and security resource, including liaising with and being knowledgeable about other related resources at Duke. Serves as an expert resource to mu ltiplestudy teams/research program with regard to mapping data flow. Predicts areas of vulnerability in the data flow plan. Determines areas where data provenance may be compromised, and helps study teams/research program staff work through solutions. Ensures that study teams are familiar with data flow resources at Duke. Seeks out, integrates, and applies new technical knowledge towards innovation and performance improvement for multiple research teams/research program, as relevant.
Science
1. Assists with or contributes to the development of funding proposals.
2. Independently reviews articles, synthesizes the literature, and uses to assist in the development of manuscripts or grant proposals.
3. Independently develops protocols for complex investigator-initiated studies, across multiple PIs or study teams.
4. Uses expertise in research design to provide significant contribution to protocols or research proposals.
5. Provides significant contribution or leadership on accepted, peer-reviewed publication or conferenc e presentation.
6. Mentors others in this area.
Study and Site Management
1. Mentors, trains, and oversees activities related to how teams communicate with sponsors and/or CROs. Oversees activities related to site visits.
2. Oversees use of systems and system reports to manage research participants' activities and track/mark financial milestones. Overseesuse of systems and system reports to manage research protocol activities and maintaining current protocol information.
3. Makes feasibility recommendations for multiple study teams/research programs. Develops and oversees processes to determine participa tion in trials.
4. Oversees management of resources (staff, supp lies, equipment) for multiple study teams/research program. May manage the budget for research studies.
5. For multiple study teams, ensures that studies are conducted in compliance with institut ional requirements and other policies.
6. Oversees implementation of operational plans across research programs, including at multiple sites.
7. Works with the CRU or departmental leadership to ensure that studies are closed according to best practices and guidelines.
Leadership
1. Encourages staff to take part in professional development opportunities. Provides opportunities for staff to attend key external offerings ( i.e. Research Wednesday, RPN, events outside of Duke, etc.).
2. Plays key role on committees and workgroups. Demonstrates interpersonal skillsto get work done efficiently. Recognizes and escalates organizational issues that could be optimized to improve research process. Actively facilitates and leads multiple study team's adoption of change in their working environment.
3. Uses advanced subject ma tter expertise in the therapeutic area or clinical research to solve pro blems across multiple study teams.
4. Trains others to communica te effectively within teams.
5. Facilitates resolution of issues associated with teams or communication.
6. Communicates effecti vely with others, regardless of reporting relationship, to accomplish sh ared work objectives.
REPORTING RELATIONSHIP: This position will report to the Department of Medicine CRU RPM. There will be dotted line reporting to the project-specific PI for scientific/project oversight. There may be an additional oversight relationship with study staff in other departments as needed.
Required Qualifications
Education/Training:
Completion of an Associate'sdegree is required. A Bache lor's degree is preferred.
Experience:
Work requires a minimum of six years of relevant research experience. A Bachelor's degree may substitute for 2 years of required experience.
Preferred Skills:
The ideal candidate will:• Possess excellent verbal and written communication skills• Possess human subject clinical research and regulatory experience• Showcase their proven ability to work both independently and within a team with excellence, dignity, and respect• Possess effective recruitment skills and comfort screening the medical record for suitability for the study• Display the ability to build longitudinal relationships with participants to ensure retention• Embody ability to manage and oversee several projects and personnel• Maintain familiarity with regulatory matters and IRB submissions and revisions• Oversee and participate in data collection and keeping accurate written and electronic records• Demonstrate flexibility and willingness to acquire new skills as the study expands• Direct the expansion of existing projects• Demonstrate the ability to plan and prioritize workload to meet deadlines, while planning and tracking the status of several projects• Exhibit familiarity or ease communicating and relating to older adults with mild Alzheimer's disease or other types of cognitive issues• Have experience with or willingness to learn the administration of neuropsychological test batteries and questionnaires with older adults as part of an evaluation for cognition• Demonstrate ability to oversee multiple personnel and students, and to train others in study processes• Demonstrate expertise in recruitment and retention of study participants• Experience with Maestro Care and OnCore preferred• Phlebotomy experience preferred
The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.
Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunities without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.
Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.
Essential Physical Job Functions
Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.
Minimum Qualifications
Education
Work requires an Associate's degree
Experience
Work requires a minimum of six years of research experience. A Bachelor's degree may substitute for 2 years of required experience.
Duke is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.
Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas-an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.
Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essentialjob functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.