Job Posting for Senior Manager of Clinical Research Compliance , Full-time at Burke Rehabilitation

Job Summary

This position will oversee the regulatory and operational aspects of all human subjects research conducted at the Winifred Masterson Burke Rehabilitation Hospital. The Senior Manager of Clinical Research Compliance will partner closely with colleagues at Albert Einstein College of Medicine to manage multisite clinical trials. He/she will serve as the key point of contact for institutional leadership, investigators, faculty, staff, the IRB, and other administrative departments. He/she will also partner with external IRBs and organizations, site personnel, and sponsors to manage a portfolio of biomedical research on behalf of the Hospital.

Job Responsibilities

Serve as the key leader for human subjects research conducted at the Winifred Masterson Burke Rehabilitation Hospital
Serve as lead contact among investigators, department administrators, IRB, and (Einstein/Montefiore) units (Conflict of Interest Office, Office of Biotechnology and Business Development, etc.)
Maintain institutional policies compliant with federal regulations (COI, FWA, ClinicalTrials.gov)
Oversee the reliance process for studies utilizing external IRBs, including the Albert Einstein College of Medicine IRB
Serve as the designated site contact for single IRB in multi-site trials
Manage reliance arrangements for cooperative research not under Einstein IRB review
Oversee site-level ancillary reviews/approval.
Notify IRB/external IRBs of any conflict of interest (individual or institutional) with a proposed research study being reviewed by the Einstein/external IRB.
Work with PIs to promptly report serious or continuing noncompliance and unanticipated problems
Assist with obtaining and maintaining data for ClinicalTrials.gov
Maintain an active Federal Wide Assurance (FWA) with OHRP
Assist Burke researchers with submissions in the electronic IRB system
Support Burke medical and research leadership in the development of guidance, procedures, and other supporting materials. Maintain up-to-date knowledge of federal and state regulations governing human subjects research.
Participate in the oversight and monitoring of investigator/coordinator compliance with IRB and institutional requirements and the approved protocol.
Assist with site-initiation visits, routine, and close-out visits to assure adherence to local and federal requirements.
Assist with internal auditing and monitoring of study protocols to ensure compliance with federal and state regulations and institutional policy.
Assure that research regulatory documents are filed and maintained in accordance with FDA and OHRP regulations, ICH guidelines, and Standard operating procedures (SOPs).
Practices Standard Precautions.
Follows regulations, policies and guidelines on the prevention of infections; does not eat or drink in patient care areas.
Maintains confidentiality of information; abides by HIPAA regulations.
Maintains a professional image and follows Hospital’s policy on uniforms; consistently wears hospital ID.
Demonstrates reliable, on-time attendance, which is an essential function of all jobs at Burke.
Completes mandatory annual learning (Learning Harbor) within deadline.
Personally adheres to Burke C.A.R.E.S. philosophy by demonstrating compassion, accountability, respect and exceeding expectations through service excellence.
Performs other job related duties as assigned.

Education And Qualifications

Bachelor's Degree
Master’s Degree (Preferred)
Relevant combination and education and experience will be considered in lieu of formal degrees

Experience

Minimum of three years IRB or clinical research experience required
Excellent knowledge of federal regulations governing human subjects research required
Ability to prioritize and manage competing deadlines
Strong analytical and problem-solving skills
Demonstrated organizational skills and ability to pay close attention to detail
Dependable, self-motivated, and able to work with minimal supervision
Excellent oral and written communication skills
Excellent computer skills

Licenses and Certifications

Certified IRB Professional (CIP) or Certified Clinical Research Professional (CCRP) certification (Preferred)

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