MD Anderson Cancer Center
Clinical Studies Coordinator, Regulatory
MD Anderson Cancer Center, Houston, Texas, United States, 77246
The Clinical Studies Coordinator ensures compliance for the execution of Kidney Cancer Research Consortium (KCRC) clinical trials, assists with the institutional and federal approval procedures for research lab and clinical trials, assuring protocol compliance and quality assurance by maintaining Standard Operating Procedures (SOPs) and workflows necessary for KCRC Operations.
KEY FUNCTIONS:
Clinical Trial Management:
Participates in the development of policies, procedures, and work flow processes to ensure Consortium efficiency and effectiveness.
Develops documentation templates and other tools as needed for clinical trial management.
Knowledge of protocol databases and tools: Internal platforms and databases such as, but not exclusive to, OnCORE, OneIRB, and Prometheus; External platforms and databases such as, but not exclusive to, FDA, safety, manuscript applications, and DOD reporting. General computer skills such as Microsoft office and others as designated.
Work closely with Prometheus team to establish thresholds for communication regarding enrollment and eligibility, patient status, toxicities, data deficiencies, protocol compliance, and safety reporting.
Collaborates with other members of the multidisciplinary team (research nurses, lab staff) as necessary.
Ongoing assessment of the performance of the SOPs and workflows per the KCRC Operations Manual.
Administrative Research Functions:
In consultation with the KCRC team, completes and submits all necessary institutional, Sponsor, IND, FDA, and other applicable required reports in a timely manner.
Participates in protocol start up meetings, on-going trainings, and close-out visits.
Responsible for querying and analyzing data sets from databases as needed.
Advocate for the clinical research process per institutional and federal regulations in keeping with Code of Federal Regulations, Good Clinical Practice, and the International Council for Harmonisation.
Routine Administrative Functions:
Demonstrates proactive and effective oral and written communication skills when contacting other institutions, patients, and agencies (i.e., NCI, pharmaceutical companies, sponsoring agencies, etc.) by phone, email, and/or face to face interactions. Assimilates pertinent information in order to compose written correspondence.
Must be able to independently initiate assignments without supervision. Able to understand and respond to telephone conversations with physicians and other members of the health care team, both within and outside the institution. Have excellent verbal and written communication skills.
Other duties as assigned.
EDUCATION:
Required: Bachelor's degree.
EXPERIENCE:
Required: Three years experience in area of research study or direct patient care obtained from nursing, data gathering or other related experience. May substitute required education degree with additional years of equivalent experience on a one to one basis. With preferred degree, one year of required experience.
Preferred; Clinical research experience with an emphasis in regulatory background.
It is the policy of The University of Texas MD Anderson Cancer Center to provide equal employment opportunity without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, disability, protected veteran status, genetic information, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. http://www.mdanderson.org/about-us/legal-and-policy/legal-statements/eeo-affirmative-action.html
Additional Information
Requisition ID: 171046
Employment Status: Full-Time
Employee Status: Regular
Work Week: Days
Minimum Salary: US Dollar (USD) 55,500
Midpoint Salary: US Dollar (USD) 69,500
Maximum Salary : US Dollar (USD) 83,500
FLSA: non-exempt and eligible for overtime pay
Fund Type: Soft
Work Location: Remote
Pivotal Position: No
Referral Bonus Available?: No
Relocation Assistance Available?: No
Science Jobs: No
#LI-Remote
KEY FUNCTIONS:
Clinical Trial Management:
Participates in the development of policies, procedures, and work flow processes to ensure Consortium efficiency and effectiveness.
Develops documentation templates and other tools as needed for clinical trial management.
Knowledge of protocol databases and tools: Internal platforms and databases such as, but not exclusive to, OnCORE, OneIRB, and Prometheus; External platforms and databases such as, but not exclusive to, FDA, safety, manuscript applications, and DOD reporting. General computer skills such as Microsoft office and others as designated.
Work closely with Prometheus team to establish thresholds for communication regarding enrollment and eligibility, patient status, toxicities, data deficiencies, protocol compliance, and safety reporting.
Collaborates with other members of the multidisciplinary team (research nurses, lab staff) as necessary.
Ongoing assessment of the performance of the SOPs and workflows per the KCRC Operations Manual.
Administrative Research Functions:
In consultation with the KCRC team, completes and submits all necessary institutional, Sponsor, IND, FDA, and other applicable required reports in a timely manner.
Participates in protocol start up meetings, on-going trainings, and close-out visits.
Responsible for querying and analyzing data sets from databases as needed.
Advocate for the clinical research process per institutional and federal regulations in keeping with Code of Federal Regulations, Good Clinical Practice, and the International Council for Harmonisation.
Routine Administrative Functions:
Demonstrates proactive and effective oral and written communication skills when contacting other institutions, patients, and agencies (i.e., NCI, pharmaceutical companies, sponsoring agencies, etc.) by phone, email, and/or face to face interactions. Assimilates pertinent information in order to compose written correspondence.
Must be able to independently initiate assignments without supervision. Able to understand and respond to telephone conversations with physicians and other members of the health care team, both within and outside the institution. Have excellent verbal and written communication skills.
Other duties as assigned.
EDUCATION:
Required: Bachelor's degree.
EXPERIENCE:
Required: Three years experience in area of research study or direct patient care obtained from nursing, data gathering or other related experience. May substitute required education degree with additional years of equivalent experience on a one to one basis. With preferred degree, one year of required experience.
Preferred; Clinical research experience with an emphasis in regulatory background.
It is the policy of The University of Texas MD Anderson Cancer Center to provide equal employment opportunity without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, disability, protected veteran status, genetic information, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. http://www.mdanderson.org/about-us/legal-and-policy/legal-statements/eeo-affirmative-action.html
Additional Information
Requisition ID: 171046
Employment Status: Full-Time
Employee Status: Regular
Work Week: Days
Minimum Salary: US Dollar (USD) 55,500
Midpoint Salary: US Dollar (USD) 69,500
Maximum Salary : US Dollar (USD) 83,500
FLSA: non-exempt and eligible for overtime pay
Fund Type: Soft
Work Location: Remote
Pivotal Position: No
Referral Bonus Available?: No
Relocation Assistance Available?: No
Science Jobs: No
#LI-Remote