Clinical Research Contract Compliance Analyst
4 weeks ago
GENERAL SUMMARY OF POSITION:
Under the general direction of the Assoc Director of Clinical Research Compliance or designee, the Clinical Research Compliance Analyst is responsible for ensuring the institutions compliance with all assigned clinical research regulatory policies and procedures.
Responsibilities:
MAJOR RESPONSIBILITIES:
Responsible for drafting, negotiating and managing a variety of clinical research contracts in a timely manner
Ensure timely completion of information in relevant contract management tool/tracking systems
Collaborate with other internal contracting department when triaging agreements to facilitate appropriate review
Implement and monitor compliance program components (such as AAHRPP accreditations, clinical trials.gov etc.)
Assist with the identification, interpretation, implementation and maintenance of relevant federal and state regulations and local policies
Prepare and assist with implementing remediation and corrective action plans, audit responses and timelines
Coordinate with staff members when needed to address compliance program matters
Assist with the development, review, and revise assigned curriculum, training materials, job aids, SOPs, and policies
Deliver compliance training and orientation to clinical research staff/faculty
Collaborate with staff to ensure that related web page content is written and maintained
Maintain various internal reporting systems, providing metrics to senior management ensuring that metrics are captured in an accurate and timely manner
Perform other duties as required.
Qualifications:
REQUIRED QUALIFICATIONS:
Bachelor's Degree in a related field, or equivalent experience
2-3 years of experience drafting and negotiating contracts/agreements related to biomedical/science industry and analyzing clinical research compliance/regulatory component areas
Working knowledge and understanding of federal, state regulation and guidance related to clinical research
Strong computer and software skills.
Additional Information:
This is a hybrid work model with the understanding that the Compliance Analyst will be available and onsite as required to support the department.
PREFERRED QUALIFICATIONS:
Certification in clinical research (CIP, SOCRA, ACRP or equivalent)
Prior experience in an academic health center or hospital
OnCore clinical trial management experience
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