Overview

GENERAL SUMMARY OF POSITION:

Under the general direction of the Assoc Director of Clinical Research Compliance or designee, the Senior Clinical Research Compliance Analyst is responsible for ensuring the institutions compliance with all assigned clinical research regulatory policies and procedures.

Responsibilities

MAJOR RESPONSIBILITIES:

• Develop, implement and monitor compliance program components (such as AAHRPP accreditation, clinicaltrials.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
• 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
• Manage daily activity of Clinical Research Compliance support staff
• Develop, review, and revise assigned curriculum, training materials, job aids, SOPs, and policies
• Deliver compliance training and orientation to clinical research staff/faculty
• 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
• 3-5 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 thedepartment. **

PREFERRED QUALIFICATIONS:

• Juris Doctor, 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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