Clinical Research Contracts Associate II

About the Role

This position is fully remote with occasional onsite time as needed. The selected candidate may only work remotely from a New England state (ME, VT, NH, MA, CT, RI).

Responsibilities

• Draft, review, negotiate, and execute a high volume of basic to complex clinical research-related agreements using DFCI template-based provisions under supervision.
• Partner with Senior Associates, Director, and/or Manager in the CRAO on all complex agreements and studies.
• Independently negotiate confidentiality agreements, clinical trial agreements, consortium agreements, multi-site and academic subcontract agreements, subcontracts, services agreements, and amendments, in collaboration with Manager and Director.
• Coordinate and hold independent meetings with industry partners to resolve contract issues.
• Work as a team member, including initiating and collaborating on complex and dual-funded combination trials.
• Respond to inquiries from Principal Investigators (PIs), study teams, OHRS, and other parties on non-complex clinical trial matters, requiring Director input and support.
• Draft written responses to inquiries from PIs, study teams, OHRS, and other parties for final review by senior management.
• Attend meetings with PIs, study teams, and other parties, contributing to discussions.
• Manage consortiums and multi-party collaborations led by DFCI/DFMGBCC.
• Develop comprehensive knowledge of institutional policies and practices to relay to PIs and study teams as rationale for contractual issues.

Requirements

• Ability to identify, suggest, and implement solutions to complex issues.
• Comprehension of science, research, and translation of medical-legal issues in clinical trials.
• Understanding of federal, state, and institutional policies and practices relevant to duties.
• Detail-oriented with excellent verbal and written communication skills.
• Proactively communicate areas needing additional training to management.
• Excellent interpersonal skills.
• Ability to manage and prioritize numerous complex agreement transactions, consulting with management to bring them to closure in a timely manner.
• Ability to work as a team member, including assisting colleagues to share caseloads.
• Ability to represent CRAO and DFHCC, possessing the confidence, trust, and respect of clinicians, scientists, administrators, investors, and external industry counterparts.
• Demonstrated ability to work in a highly matrixed and complex organization with multiple stakeholders.

Qualifications

• Juris Doctor (J.D).
• Minimum of 1 year of strong clinical trial contracts negotiation experience.
• Prior experience working in an academic healthcare institution or bio-pharma industry.
• Basic knowledge of clinical trials.

Pay

$100,400.00 - $117,600.00