Clinical Contracts Specialist

Overview

This Contract position supports clinical research contracting and informed consent documentation. The Clinical Contracts Specialist independently manages the lifecycle of clinical research agreements and informed consent documents to support site activation, participant enrollment, study execution, and inspection readiness. The role serves as a primary operational point of contact for contracting and consent activities, negotiates terms within established parameters, and ensures compliance with protocols, regulatory requirements, and internal standards.

Responsibilities

• Independently administer and manage the lifecycle of standard and moderately complex clinical research agreements, including Clinical Trial Agreements (CTAs), site agreements, confidentiality agreements, amendments, and other research-related agreements from initiation through negotiation, execution, amendment, and closeout.
• Negotiate clinical research contract terms with research sites, institutions, CROs, and other external parties within established parameters and delegated authority; resolve routine and moderately complex issues and escalate significant legal, regulatory, privacy, financial, or business risks as appropriate.
• Serve as the primary operational point of contact for assigned clinical research contracting and informed consent activities, driving deliverables and timelines required to support site activation, enrollment, study execution, and closeout.
• Independently coordinate and manage the development, review, negotiation, approval, implementation, and maintenance of Informed Consent Forms (ICFs) and related participant-facing consent documents in accordance with approved protocols, sponsor requirements, IRB/Ethics Committee requirements, applicable regulations, and internal standards.
• Evaluate site-specific modifications to informed consent language, resolving changes within established parameters and determining when proposed deviations require escalation to Legal, Regulatory, Privacy, Clinical, or other subject-matter experts.
• Review clinical research agreements, site budgets, payment terms, consent requirements, and related study documentation to identify inconsistencies, operational risks, or requirements that may affect site activation, enrollment, study execution, or compliance.
• Partner cross-functionally with Clinical Affairs, Legal, Regulatory, Privacy, Finance, study teams, CROs, and other stakeholders to resolve contracting and consent issues and drive decisions necessary to maintain study timelines.
• Proactively identify contract and consent-related risks, delays, and dependencies and develop or recommend solutions to minimize impact on study milestones.
• Manage informed consent changes resulting from protocol amendments, emerging safety information, regulatory requirements, or IRB/EC requests and coordinate implementation and reconsent requirements across assigned studies and sites.
• Provide guidance to study teams and sites regarding approved contract and consent processes, templates, requirements, and escalation pathways.
• Ensure executed contracts, approved informed consent documents, amendments, correspondence, and supporting documentation are appropriately maintained in applicable clinical systems and repositories in accordance with Trial Master File (TMF), document retention, and inspection-readiness requirements.
• Perform periodic reconciliation and quality review of contractual and consent documentation and independently address identified gaps or deficiencies.
• Monitor and analyze contract cycle times, consent approval timelines, negotiation trends, recurring site requests, and operational bottlenecks and recommend actions to improve performance.
• Develop or recommend enhancements to contract and consent templates, negotiation playbooks, tracking tools, workflows, and procedures to improve cycle time, quality, consistency, compliance, and scalability.
• Support implementation of process improvements and cross-functional initiatives related to clinical research contracting, informed consent management, site activation, and clinical documentation.
• Communicate risks, status, recommendations, and potential solutions to stakeholders to support decision-making and achievement of study milestones.

Essential Skills

• High School Diploma or equivalent with 4+ years of relevant experience in clinical research, clinical research contracts, clinical operations, regulatory documentation, informed consent administration, contracts administration, or equivalent experience; OR Associate's Degree with 2+ years of relevant experience; OR Baccalaureate Degree with 1+ year of relevant experience.
• Working knowledge of Good Clinical Practice (GCP), clinical research processes, informed consent requirements, clinical study documentation, and research-site operations.
• Experience administering or negotiating clinical research agreements, managing informed consent documents, supporting IRB/EC processes, or performing related clinical research activities (preferred but strongly beneficial).
• Demonstrated ability to independently manage multiple agreements, sites, priorities, and timelines while maintaining attention to detail and quality.
• Ability to identify, assess, and escalate contractual, operational, regulatory, privacy, or compliance risks appropriately.
• Experience with clinical trial management systems, contract lifecycle management systems, electronic Trial Master File (eTMF) systems, or similar clinical research platforms (preferred).
• Ability to interpret and apply protocols, sponsor requirements, IRB/Ethics Committee requirements, and applicable regulations to contract and consent activities.
• Strong analytical skills to review agreements, budgets, payment terms, and consent requirements and identify inconsistencies or operational risks.
• Effective communication skills to interact frequently with Clinical Affairs, Legal, Regulatory, Privacy, Finance, Clinical Operations, study leadership, research sites, investigators, study coordinators, institutional contracting offices, CROs, and IRBs/ECs.
• Capacity to work as an established and productive individual contributor, exercising judgment in resolving routine and moderately complex contract and consent issues.

Compensation & Benefits

• Pay range: $35.00 - $65.00/hr
• Individual compensation offered within this range will depend on qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other job-related factors.

Benefits (eligibility requirements apply and may depend on job classification and length of employment; subject to change):

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan
  • Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Location

• Workplace type: Fully remote
• Base location: Maple Grove, MN

Application Deadline

This position is anticipated to close on Nov 11, 2026.

Equal Opportunity

The employer considers applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information, or any characteristic protected by law.

Reasonable Accommodation

Reasonable accommodations are available for modifications or adjustments to the job application process or interviewing process due to a disability.

Additional Notices

• San Francisco Fair Chance Ordinance: For positions located in the city and county of San Francisco, qualified applicants with arrest and conviction records will be considered.
• Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment.
• Use of Artificial Intelligence (AI): AI may be used to support parts of the hiring process, including sourcing, screening, and evaluating candidates. Final decisions are made by the hiring team; applying acknowledges that applications may be reviewed using AI tools.