Remote Clinical Contracts & Consent Specialist

Actalent; Maple Grove (MN); À distance; USD 48 000 - 90 000; Plein temps

Avantages offerts par ce poste

Medical, dental & vision

401(k) Retirement Plan

Pre-tax and Roth post-tax benefits

Life Insurance (Voluntary)

Paid Time Off

Résumé du poste

Actalent is seeking a Clinical Contracts Specialist to independently manage the full lifecycle of clinical research agreements and informed consent documents. You will negotiate terms with sites and external partners, ensure regulatory compliance, and coordinate ICF development for site activation and study execution.

The role requires strong attention to detail, risk assessment, and cross-functional collaboration with Clinical Affairs, Legal, Regulatory, and Finance.

Qualifications

• 4+ years in clinical research, clinical contracts, or related field; or 2+ years with an Associate degree; or 1+ year with a Bachelor's.
• Working knowledge of GCP and regulatory processes.
• Experience administering or negotiating clinical research agreements and managing informed consent docs (preferred).
• Ability to manage multiple agreements, sites, priorities, and timelines with attention to detail.
• Identify, assess, and elevate contractual, regulatory, privacy, or compliance risks.
• Experience with clinical trial management or eTMF systems (preferred).
• Interpret protocols and sponsor/IRB requirements for contracts and consents.
• Strong analytical skills to review budgets and payment terms.
• Excellent cross-functional communication with stakeholders.
• Capable of independent contribution and resolving routine issues.

Responsabilités

• Negotiate contract terms with research sites within established parameters.
• Drive deliverables and timelines for site activation, enrollment, and study execution.
• Coordinate development and approval of informed consent forms and participant-facing documents.
• Escalate significant legal or regulatory issues as needed.
• Maintain TMF and study documentation for inspection readiness.
• Monitor contract cycle times and identify bottlenecks.
• Support process improvements in contracting and consent management.
• Provide guidance on approved contract and consent processes to study teams.

Connaissances

GCP knowledge

Clinical research processes

Informed consent requirements

Contract lifecycle management

Regulatory documentation

Effective communication

Independent multitasking

Formation

High School diploma or equivalent

Associate's degree

Bachelor's degree

Outils

Clinical trial management systems

Contract lifecycle management systems

eTMF systems

Description du poste

Actalent is seeking a Clinical Contracts Specialist to independently manage the full lifecycle of clinical research agreements and informed consent documents. You will negotiate terms with sites and external partners, ensure regulatory compliance, and coordinate ICF development for site activation and study execution.

The role requires strong attention to detail, risk assessment, and cross-functional collaboration with Clinical Affairs, Legal, Regulatory, and Finance.