WEST VIRGINIA UNIVERSITY RESEARCH CORPORATION
(Hybrid) Regulatory Coordinator - Cancer Institute/Clinical Research Unit
WEST VIRGINIA UNIVERSITY RESEARCH CORPORATION, Morgantown, West Virginia, United States, 26501
Description
The Cancer Institute Clinical Research Unit at West Virginia University Research Corporation is currently accepting applications for a (Hybrid) Regulatory CoordinatorAbout the OpportunityThe Protocol Management Office (PMO) as a unit within the WVU Cancer Institute Clinical Research Unit (WVUCI CRU) is tasked with general regulatory and financial oversight of all active WCUCI clinical research studies from open to accrual through termination.Under the direction of the Protocol Management Manager, the Regulatory Coordinator position is responsible for completing all regulatory activities associated with active industry and cooperative group sponsored clinical studies. The Regulatory Coordinator is also tasked with the start-up of cooperative group sponsored clinical studies.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 DoCooperative Group Protocol Start-up Activities: The Regulatory Coordinator is responsible for the study start-up activities for cooperative group sponsored protocols.Facilitates new protocol submission for disease team and protocol review committee reviews and notifies relevant research staff of approvalsPrepares and submits new and annual Principal Investigator Worksheets for the NCI CIRBSubmits Study Specific Worksheets for new protocol to the NCI CIRB and prepares informed consent forms in accordance with InstitutionalSubmits new protocols to the WVU IRB for local review and acknowledgementSchedules and assists in making materials for site initiation visitsCreates initial delegation and training logs
Protocol Maintenance Activities: The Regulatory Coordinator is responsible for the lifetime management of all WVUCI industry-sponsored, and cooperative-group sponsored protocols.Prepares and submits IRB continuing reviews and amendment reviewUpdates protocol specific regulatory documents including FDA Form 1572, Financial Disclosure Forms, Delegation Logs, and Training Logs as needeReviews all protocol specific deviations, safety reports, and adverse event reports for reportability, and submits to the IRB when applicablResponds to questions regarding regulatory issues, including queries from internal quality review and the Data Safety and Toxicity CommitteParticipates in WVUCI disease team-oriented research meetings, to also include research affiliate network, with investigators and coordinators to ensure prompt and accurate communication of changes in the protocol plan, IRB comments and other regulatory itemPrepares for study monitoring and auditing visits by reviewing all protocol specific regulatory files and reconciling as needed. Notifies appropriate institutional officials of external audits by FDA and sponsorMaintains professional and prompt communications with investigators, coordinators, and sponsors as required
Protocol Closeout Activities: The Regulatory Coordinator is also responsible for coordinating and completing cooperative-group and industry-sponsored protocol closeout activities.Reviews and reconciles regulatory files with sponsor monitorsCoordinates and attends study closeout visitsCoordinates and attends study close out visitsPrepares and submits study IRB closures
Professional Development:Maintains 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 field.A minimum of two (2) years of experience in the following:Experience in regulatory aspects of industry and government sponsored clinical trials and investigator initiated clinical trials
Any 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 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 capability.Proven ability to handle confidential information with discretion, be adaptable to various competing demands, and demonstrate the highest level of customer/client service and response.Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment.Proficiency with Microsoft Office suite, particularly Outlook, Excel, Word.Working knowledge of regulatory aspects of industry and government sponsored clinical trials including IRB regulations.Ability 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: Nov 6, 2024 Posting Classification: Research Corporation Exemption Status: Exempt Benefits Eligible: Yes Schedule: Full-time
The Cancer Institute Clinical Research Unit at West Virginia University Research Corporation is currently accepting applications for a (Hybrid) Regulatory CoordinatorAbout the OpportunityThe Protocol Management Office (PMO) as a unit within the WVU Cancer Institute Clinical Research Unit (WVUCI CRU) is tasked with general regulatory and financial oversight of all active WCUCI clinical research studies from open to accrual through termination.Under the direction of the Protocol Management Manager, the Regulatory Coordinator position is responsible for completing all regulatory activities associated with active industry and cooperative group sponsored clinical studies. The Regulatory Coordinator is also tasked with the start-up of cooperative group sponsored clinical studies.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 DoCooperative Group Protocol Start-up Activities: The Regulatory Coordinator is responsible for the study start-up activities for cooperative group sponsored protocols.Facilitates new protocol submission for disease team and protocol review committee reviews and notifies relevant research staff of approvalsPrepares and submits new and annual Principal Investigator Worksheets for the NCI CIRBSubmits Study Specific Worksheets for new protocol to the NCI CIRB and prepares informed consent forms in accordance with InstitutionalSubmits new protocols to the WVU IRB for local review and acknowledgementSchedules and assists in making materials for site initiation visitsCreates initial delegation and training logs
Protocol Maintenance Activities: The Regulatory Coordinator is responsible for the lifetime management of all WVUCI industry-sponsored, and cooperative-group sponsored protocols.Prepares and submits IRB continuing reviews and amendment reviewUpdates protocol specific regulatory documents including FDA Form 1572, Financial Disclosure Forms, Delegation Logs, and Training Logs as needeReviews all protocol specific deviations, safety reports, and adverse event reports for reportability, and submits to the IRB when applicablResponds to questions regarding regulatory issues, including queries from internal quality review and the Data Safety and Toxicity CommitteParticipates in WVUCI disease team-oriented research meetings, to also include research affiliate network, with investigators and coordinators to ensure prompt and accurate communication of changes in the protocol plan, IRB comments and other regulatory itemPrepares for study monitoring and auditing visits by reviewing all protocol specific regulatory files and reconciling as needed. Notifies appropriate institutional officials of external audits by FDA and sponsorMaintains professional and prompt communications with investigators, coordinators, and sponsors as required
Protocol Closeout Activities: The Regulatory Coordinator is also responsible for coordinating and completing cooperative-group and industry-sponsored protocol closeout activities.Reviews and reconciles regulatory files with sponsor monitorsCoordinates and attends study closeout visitsCoordinates and attends study close out visitsPrepares and submits study IRB closures
Professional Development:Maintains 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 field.A minimum of two (2) years of experience in the following:Experience in regulatory aspects of industry and government sponsored clinical trials and investigator initiated clinical trials
Any 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 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 capability.Proven ability to handle confidential information with discretion, be adaptable to various competing demands, and demonstrate the highest level of customer/client service and response.Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment.Proficiency with Microsoft Office suite, particularly Outlook, Excel, Word.Working knowledge of regulatory aspects of industry and government sponsored clinical trials including IRB regulations.Ability 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: Nov 6, 2024 Posting Classification: Research Corporation Exemption Status: Exempt Benefits Eligible: Yes Schedule: Full-time