WEST VIRGINIA UNIVERSITY RESEARCH CORPORATION
(Hybrid) Protocol Development Project Manager - Cancer Institute/Clinical Resear
WEST VIRGINIA UNIVERSITY RESEARCH CORPORATION, Morgantown, West Virginia, United States, 26501
Description
The WVU Cancer Institute/Clinical Research Trials at West Virginia University Research Corporation is currently accepting applications for a (Hybrid) Protocol Development Project ManagerAbout the OpportunityThe Protocol Development Office (PDO) as a unit within the WVU Cancer Institute Clinical Research Unit (WVUCI CRU) is tasked with the development, activation, and management of clinical research protocols to be conducted at the WVUCI. The PDO also serves as the Investigator-Initiated Trials (IIT) Management Team for all WVUCI single and multi-site IITs. Under the direction of the Protocol Development Manager, the Project Manager position is responsible for coordinating and completing protocol start-up activities from feasibility assessment to open to enrollment for industry-sponsored and investigator-initiated clinical research protocols for the WVUCI. The Project Manager is also tasked with the lifetime management of all WVUCI single and multi-site IITs.At WVU Research Corporation, we strongly believe in work-life balance and keeping time for things we love outside our work. WVU Research Corporation offers a comprehensive benefits package with a variety of options to suit your needs:13 paid holidays (staff holiday calendar)Paid Time off (PTO)403(b) retirement savings with a fully vested 3% employee contribution match, (Employees have the option of contributing an additional 1-3% of their earnings to the plan, which is also matched by the WVURC)A range of health insurance and other benefitsDependent Education ScholarshipWVU Perks
What You'll Do:The Project Manager is responsible for the pre-site selection process for industry sponsored protocols. The Project Manager:Engages with industry sponsors to assess sponsor interest and confirms PI interestCoordinates the review and execution of clinical trial CDAsCoordinates with the clinical team to fill out and complete protocol feasibility questionnairesSchedules and attends pre-qualification visitsNotifies study team of site selection or rejection
The PDO Project Manager is responsible for coordinating and/or completing all industry sponsored protocol start-up activities:Submits protocol documents for disease team review and attends all disease team meetings with new protocol presentationsCoordinates the submission of disease team approved protocols to the protocol review committee and attends all protocol review committee meetingsWorks with the Business coordinator to ensure timely clinical trial budget and contract executionDevelops and prepares informed consent documents according to institutional guidelinesPrepares and submits Institutional Review Board (IRB) initial reviews and tracks all IRB submissions and communicates with IRB administration regarding new submissionsCompletes clinical trial regulatory documents including FDA Form 1572, Financial Disclosure Forms, training records, and delegation logsSchedules and attends all protocol site initiation visitsMonitors, evaluates, and improves start-up activity tracking systems and timelinesFacilitates the transition of study management to the Protocol Management Office once a study is open to enrollment
The PDO Project Manager is also responsible for coordinating/and or completing IIT protocol development and start-up activities:Assists in the development of IIT protocols using WVUCI CRU protocol templatesAssists in creation and writing of IIT informed consent forms in accordance with Institutional, FDA, ICH, and GCP guidelinesWorks with Industry sponsors to complete Letters of Cross Reference when applicableAssists in the writing and submission of Investigational New Drug applications to the FDA and completes all required regulatory documents including FDA Form 1572, Financial Disclosure Forms, training records, and delegation logsSubmits protocol documents for disease team review and attends all disease team meetings with new protocol presentationsCoordinates the submission of disease team approved protocols to the protocol review committee and attends all protocol review committee meetingsWorks with the Business coordinator to ensure timely clinical trial budget and contract execution when applicable.Prepares and submits IRB initial reviews and tracks all IRB submissions and communicates with IRB administration regarding new submissionsSchedules and helps develop materials for site initiation visits
The PDO Project Manager is responsible for the lifetime management of all WVUCI IITs. The Project Manager:Prepares and submits IRB continuing reviewsPrepares and submits FDA annual reportsAssists in writing protocol and informed consent document amendments and submits amendments to the IRB and FDAAssists with the submission of safety reports and adverse event reports to the IRB and FDAResponds to questions regarding regulatory issues, including queries from internal quality review and the Data Safety and Toxicity CommitteeSubmits appropriate documents to close or suspend study protocolCooperates with University compliance and monitoring efforts related to sponsored program administration and reports instances of noncompliance to the appropriate personnel. Coordinates and facilitates monitoring and auditing visits. Notifies appropriate institutional officials of external audits by FDA and sponsorsMaintains professional and prompt communications with investigators, coordinators and sponsors as required
Professional DevelopmentMaintains knowledge of professional principles, legal and/or reporting requirements affecting area of responsibility, and adheres to industry and government standardsParticipates in networking opportunities, and continuing educationAttends conferences when appropriate
Qualifications
Bachelor's degree in an allied health discipline or related fieldA minimum of two (2) years experience in the following:Experience in regulatory aspects of industry sponsored and investigator initiated clinical trials.
An equivalent combination of related education and/or experience will be considered.All qualifications must be met by the time of employment.
Knowledge, Skills and AbilitiesUnderstanding of research ethics and the responsible conduct of research, with a focus on the regulations and guidelines governing human subject clinical trials;Strong desire to learn, seek out, and apply new knowledge, methods, and information;Strong interpersonal skills, as well as the ability to work with a broad range of people including investigators, physicians, clinic and hospital staff, sponsors, partners at other institutions, WVUCI staff, and others;Highly resourceful team-player, with the ability to also be extremely effective, independent, interact professionally, and utilize effective writing and organizational skills;Proven sense of professional ethics and conduct, understanding and effectively using and applying Emotional Intelligence strategies and skills;Forward-thinking mentality, actively seeking opportunities and proposing creative solutions with strong decision-making capabilityProven ability to handle confidential information with discretion, be adaptable to various competing demands, and demonstrate the highest level of customer/client service and responseDemonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment;Proficiency with Microsoft Office suite, particularly Outlook, Excel, WordWorking knowledge of regulatory aspects of industry and government sponsored clinical trials including IRB regulationsAbility to read, analyze and interpret general business periodicals, professional journals, technical procedures or governmental regulationsAbility to manage multiple projects and changing priorities
Requirements
Research Certification with SOCRA or ACRP preferred or able to obtain with in 6 months of hire.
About Research Corporation
The WVURC was created as a not-for-profit corporation in 1985 to support research (R1) at West Virginia University. We provide evaluation, development, patenting, management, and marketing services for inventions of the faculty, staff and students of the University.
The WVURC receives and administers funds awarded by external agencies for research and other activities and is responsible for helping protect intellectual property through patents, copyrights and licensing agreements for start-up companies based on University research.
West Virginia University Research Corporation is proud to be an Equal Opportunity employer. We value diversity among its employees and invites applications from all qualified applicants regardless of race, ethnicity, color, religion, gender identity, sexual orientation, age, nationality, genetics, disability, or Veteran status.Job Posting: Sep 18, 2024 Posting Classification: Research Corporation Exemption Status: Exempt Benefits Eligible: Yes Schedule: Full-time
The WVU Cancer Institute/Clinical Research Trials at West Virginia University Research Corporation is currently accepting applications for a (Hybrid) Protocol Development Project ManagerAbout the OpportunityThe Protocol Development Office (PDO) as a unit within the WVU Cancer Institute Clinical Research Unit (WVUCI CRU) is tasked with the development, activation, and management of clinical research protocols to be conducted at the WVUCI. The PDO also serves as the Investigator-Initiated Trials (IIT) Management Team for all WVUCI single and multi-site IITs. Under the direction of the Protocol Development Manager, the Project Manager position is responsible for coordinating and completing protocol start-up activities from feasibility assessment to open to enrollment for industry-sponsored and investigator-initiated clinical research protocols for the WVUCI. The Project Manager is also tasked with the lifetime management of all WVUCI single and multi-site IITs.At WVU Research Corporation, we strongly believe in work-life balance and keeping time for things we love outside our work. WVU Research Corporation offers a comprehensive benefits package with a variety of options to suit your needs:13 paid holidays (staff holiday calendar)Paid Time off (PTO)403(b) retirement savings with a fully vested 3% employee contribution match, (Employees have the option of contributing an additional 1-3% of their earnings to the plan, which is also matched by the WVURC)A range of health insurance and other benefitsDependent Education ScholarshipWVU Perks
What You'll Do:The Project Manager is responsible for the pre-site selection process for industry sponsored protocols. The Project Manager:Engages with industry sponsors to assess sponsor interest and confirms PI interestCoordinates the review and execution of clinical trial CDAsCoordinates with the clinical team to fill out and complete protocol feasibility questionnairesSchedules and attends pre-qualification visitsNotifies study team of site selection or rejection
The PDO Project Manager is responsible for coordinating and/or completing all industry sponsored protocol start-up activities:Submits protocol documents for disease team review and attends all disease team meetings with new protocol presentationsCoordinates the submission of disease team approved protocols to the protocol review committee and attends all protocol review committee meetingsWorks with the Business coordinator to ensure timely clinical trial budget and contract executionDevelops and prepares informed consent documents according to institutional guidelinesPrepares and submits Institutional Review Board (IRB) initial reviews and tracks all IRB submissions and communicates with IRB administration regarding new submissionsCompletes clinical trial regulatory documents including FDA Form 1572, Financial Disclosure Forms, training records, and delegation logsSchedules and attends all protocol site initiation visitsMonitors, evaluates, and improves start-up activity tracking systems and timelinesFacilitates the transition of study management to the Protocol Management Office once a study is open to enrollment
The PDO Project Manager is also responsible for coordinating/and or completing IIT protocol development and start-up activities:Assists in the development of IIT protocols using WVUCI CRU protocol templatesAssists in creation and writing of IIT informed consent forms in accordance with Institutional, FDA, ICH, and GCP guidelinesWorks with Industry sponsors to complete Letters of Cross Reference when applicableAssists in the writing and submission of Investigational New Drug applications to the FDA and completes all required regulatory documents including FDA Form 1572, Financial Disclosure Forms, training records, and delegation logsSubmits protocol documents for disease team review and attends all disease team meetings with new protocol presentationsCoordinates the submission of disease team approved protocols to the protocol review committee and attends all protocol review committee meetingsWorks with the Business coordinator to ensure timely clinical trial budget and contract execution when applicable.Prepares and submits IRB initial reviews and tracks all IRB submissions and communicates with IRB administration regarding new submissionsSchedules and helps develop materials for site initiation visits
The PDO Project Manager is responsible for the lifetime management of all WVUCI IITs. The Project Manager:Prepares and submits IRB continuing reviewsPrepares and submits FDA annual reportsAssists in writing protocol and informed consent document amendments and submits amendments to the IRB and FDAAssists with the submission of safety reports and adverse event reports to the IRB and FDAResponds to questions regarding regulatory issues, including queries from internal quality review and the Data Safety and Toxicity CommitteeSubmits appropriate documents to close or suspend study protocolCooperates with University compliance and monitoring efforts related to sponsored program administration and reports instances of noncompliance to the appropriate personnel. Coordinates and facilitates monitoring and auditing visits. Notifies appropriate institutional officials of external audits by FDA and sponsorsMaintains professional and prompt communications with investigators, coordinators and sponsors as required
Professional DevelopmentMaintains knowledge of professional principles, legal and/or reporting requirements affecting area of responsibility, and adheres to industry and government standardsParticipates in networking opportunities, and continuing educationAttends conferences when appropriate
Qualifications
Bachelor's degree in an allied health discipline or related fieldA minimum of two (2) years experience in the following:Experience in regulatory aspects of industry sponsored and investigator initiated clinical trials.
An equivalent combination of related education and/or experience will be considered.All qualifications must be met by the time of employment.
Knowledge, Skills and AbilitiesUnderstanding of research ethics and the responsible conduct of research, with a focus on the regulations and guidelines governing human subject clinical trials;Strong desire to learn, seek out, and apply new knowledge, methods, and information;Strong interpersonal skills, as well as the ability to work with a broad range of people including investigators, physicians, clinic and hospital staff, sponsors, partners at other institutions, WVUCI staff, and others;Highly resourceful team-player, with the ability to also be extremely effective, independent, interact professionally, and utilize effective writing and organizational skills;Proven sense of professional ethics and conduct, understanding and effectively using and applying Emotional Intelligence strategies and skills;Forward-thinking mentality, actively seeking opportunities and proposing creative solutions with strong decision-making capabilityProven ability to handle confidential information with discretion, be adaptable to various competing demands, and demonstrate the highest level of customer/client service and responseDemonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment;Proficiency with Microsoft Office suite, particularly Outlook, Excel, WordWorking knowledge of regulatory aspects of industry and government sponsored clinical trials including IRB regulationsAbility to read, analyze and interpret general business periodicals, professional journals, technical procedures or governmental regulationsAbility to manage multiple projects and changing priorities
Requirements
Research Certification with SOCRA or ACRP preferred or able to obtain with in 6 months of hire.
About Research Corporation
The WVURC was created as a not-for-profit corporation in 1985 to support research (R1) at West Virginia University. We provide evaluation, development, patenting, management, and marketing services for inventions of the faculty, staff and students of the University.
The WVURC receives and administers funds awarded by external agencies for research and other activities and is responsible for helping protect intellectual property through patents, copyrights and licensing agreements for start-up companies based on University research.
West Virginia University Research Corporation is proud to be an Equal Opportunity employer. We value diversity among its employees and invites applications from all qualified applicants regardless of race, ethnicity, color, religion, gender identity, sexual orientation, age, nationality, genetics, disability, or Veteran status.Job Posting: Sep 18, 2024 Posting Classification: Research Corporation Exemption Status: Exempt Benefits Eligible: Yes Schedule: Full-time