Senior Coordinator, Research Department

$70,000.00 - $80,000.00 per year Pay Transparency: The above reflects the anticipated annual salary range for this position if hired to work in New Jersey. The compensation offered to the candidate selected for the position will depend on several factors, including the candidate's educational background, skills and professional experience. Section II: Summary of Job Function Under the supervision of the Manager of the Clinical Research Office, the IRB Coordinator will assist in the overall coordination and compliance of research at Cooperman Barnabas Medical Center, The Senior Coordinator will assist in the overall coordination and compliance of research at Cooperman Barnabas Medical Center.

The IRB Senior Coordinator will manage the privileged and confidential institutional review and approval process of all proposed research activities involving human subjects to protect their softy, right and welfare. Perform highly complex duties to facilitate the review and approval process, such as the use of independent judgment in interpreting and applying relevant federal and state laws, regulations and institutional policies and guidelines; instruct IRB Chairs, members, and researchers on the regulations and ethical principles essential to the review process; provide training and advice to faculty, staff, and student researchers on the regulations and preparation of applications and consent forms.

Review and approve administrative and procedural modifications of applications. As a Senior Coordinator, typical day might include the following: Serving as Coordinator of the IRB by coordinating all activities and services in support of the committee and processing all research protocols for appropriate review Analyzing all protocol submissions for completeness and accuracy, recommending the appropriate level of IRB review in accordance with federal and institutional codes, rules and regulations governing biomedical research Drafting correspondence that conveys IRB deliberations and contingencies for approval of research activities involving human subjects Serving as point of contact on IRB-related Serves as point of contact on IRB-related issues Providing regulatory, ethical, and methodological advice to investigators, staff, and students in preparing applications for research proposals involving human subjects.

Assisting in providing guidance and consultation to IRB members and investigators regarding implementation of regulations, policies, and procedures Ensuring that all IRB activities and documents are in compliance with OHRP and FDA regulations, including maintaining the institution’s Federal Wide Assurance (FWA) Distributing and collecting annual protocol reviews, conflict of interest forms and follow-up to ensure completion of required information Monitoring, analyzing and transmitting information to the IRB and investigators on new and/or modified protocols for proper review and conduct of clinical research Assisting the IRB Chair with processing of emergency use protocols and convening special meetings as necessary Maintaining IRB tracking/monitoring databases Maintains IRB tracking/monitoring databases and files Serving as coordinator of the Institutional Research Committee (IRC) Coordinating all activities in support of the committee for the feasibility and operational reviews of research protocols Scheduling IRC meetings; prepare agendas and distributes meeting minutes, and other related correspondence; including IRC deliberations and contingencies for approvals Attending other research-related meetings as requested by Chair and Clinical Research Office Attending local and national conferences and seminars to keep abreast of regulatory and legislative requirements related to research Communicating with other system IRB Coordinators on matters of common interest Working cooperatively with other staff in the Clinical Research Office on projects assigned by the Department Head Ensuring IRB staff and investigators complete initial human subjects’ protection training and periodic refresher courses.

(e,g. CITI Trainings) Facilitating and maintaining IRB Accreditation for Cooperman Barnabas Medical Center, Clara Mass Medical Center, and Barnabas Health Medical Group. Serve as point of contact on IRB-related issues Interpreting and applying federal and state laws, regulations, institutional policies and guidelines to protect human subjects and to ensure institutional compliance by providing regulatory, ethical, and methodological advice to investigators, staff, residents and students in preparing applications for research proposals involving human subjects as needed or required Collaborating with system IRB Coordinators/Administrators towards system-wide integration and harmonization of a centralized IRB and IRC Providing guidance and education to investigators and research staff on IRB policies, procedures, and applicable federal regulations Developing and maintaining educational materials (e.g. guides, templates, checklists, FAQs) to promote understanding and ensure compliance with human subjects’ research requirements The Senior Coordinator role might be for you if: You enjoy working in a fast-paced healthcare environment where no two days are the same You thrive on staying organized and balancing multiple priorities You take pride in providing outstanding customer service and compassionate support You are comfortable using computers and learning electronic health record systems You enjoy being part of a collaborative team dedicated to delivering exceptional patient care You're seeking a healthcare career where your organizational skills directly support clinical excellence To be considered for this position, candidates must have Bachelor’s degree in a scientific field or health related field required.

Master’s degree preferred. At least three years of experience related to clinical research or research administration. Knowledge of state and federal regulations governing the ethical conduct of research and protection of human subjects.

Knowledge and understanding of IRB regulations and ICH/GCP guidelines. Collaborate with the IRB Chair regarding IRB education, Department Management, IRB Membership, Administration, Medical Staff, Research Staff, and Regulatory Agencies. Excellent verbal and written communication skills.

Can work with minimal supervision and can function independently. Ability to conduct independent literature research including Internet-based research. Time management skills and ability to prioritize and who can deal with high volumes and rigid deadlines.

Experience with computer applications, particularly proficiency with Microsoft Word, Excel, and PowerPoint. Comprehensive knowledge of medical terminology preferred. Experience with IRB/Research Management Systems (e.g.

ProIRB, Oncore, or related systems preferred. Monday-Friday with flexibility with hours to start on day shift.

Day shift · 37.5