This position's work location is fully remote with occasional time onsite as needed. The selected candidate may only work remotely from a New England state (ME, VT, NH, MA, CT, RI).
The Clinical Research Contracts Associate II will draft, review, negotiate and execute a high-volume of basic to complex clinical research related agreements. Works under supervision on clinical research related agreements based on DFCI template based agreement model provisions. Partners with Senior Associates, Director and/or Manager in the CRAO on all complex agreements and studies.
Agreements/Transactions
- Uses institutional templates and checklist guidelines to guide negotiations and drafts creative language to address departures from templates, to be approved by management.
- Independently negotiates but under collaboration with Manager and Director , confidentiality agreement, clinical trial agreements, consortium agreements, multi-site and academic subcontract agreements, subcontracts, services agreements and amendments to the foregoing.
- Coordinates and holds independent meetings with industry partners to resolve contract issues
- Ability to work as a member of a team. Ability to initiate and successfully collaborate with team members on complex and dual funded combination trials.
PI Relationship Management/Communication
- Responds to inquiries from PIs , study teams , OHRS a,nd other parties on non-complex clinical trial related matters, requiring Director input and support.
- Drafts written response messages to inquiries from PIs , study teams , OHRS and other parties, for final review by senior management.
- Attends meetings with PIs, study teams and other parties, with contributing role in discussions
- Manages consortiums and multi-party collaborations led by DFCI/DFMGBCC Develops comprehensive knowledge of institutional policies and practices to that is relayed to PIs and Study Teams as rationale of contractual issues
KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED: - Ability to identify and suggest and implement solutions to complex issues.
- Comprehension of science, research and translation of medical legal issues in clinical trials
- Understanding and comprehension of federal, state and institutional policies and practices relevant to duties and responsibilities
- Detail-oriented
- Excellent verbal and written communication skills required.
- Communicates proactively to management areas lacking full comprehension and knowledge to identify areas needing additional training.
- Excellent interpersonal skills
- Ability to manage and prioritize numerous complex agreement transactions and consulting with management bring to closure in a timely manner.
- Ability to work as a member of a team including taking work on from/assisting colleagues to share caseloads.
- Ability to represent CRAO and DFHCC and possesses the confidence, trust and respect of clinicians, scientists, administrators, investors, external industry counterparts.
- Demonstrates the ability to work in a highly matrixed and complex organization with multiple stakeholders.
MINIMUM JOB QUALIFICATIONS:Minimum Education: Juris Doctor (J.D)
Minimum Experience:
- Minimum 1 year strong clinical trial contracts negotiation experience required
- Prior experience working in an academic healthcare institution or bio-pharma industry
- Basic knowledge of clinical trials
The hiring range is based on market pay structures, with individual salaries determined by factors such as business needs, market conditions, internal equity, and based on the candidate's relevant experience, skills and qualifications.
For union positions, the pay range is determined by the Collective Bargaining Agreement (CBA).
$100,400.00 - $117,600.00
