Clinical Contract Analyst Exempt

Three Point Solutions

Job Location:

Any - USA

Monthly Salary: Not Disclosed

Posted on: 25 days ago

Vacancies: 1 Vacancy

Job Summary

Job Title: Clinical Contract Analyst

Client: Medical Device Manufacturing Company
Duration: 2 Years (Possible Extension)
Location: 100% Remote
Shift: 1st Shift

Position Overview:

The Contract Analyst (Informed Consent Specialist) acts as the primary point of contact for managing and negotiating patient informed consent (IC) documents within U.S. clinical research operations. This role supports cross-functional teams-including clinical legal and contracts-ensuring all informed consent templates and approvals meet regulatory and ethical standards while accelerating study start-up timelines.

Key Responsibilities: Informed Consent Management

Serve as the lead liaison between study teams research centers and IRBs/ECs for IC-related activities.
Develop review and customize IC templates per site and ethics committee requirements.
Ensure alignment between Clinical Trial Agreements (CTAs) and associated ICs.
Coordinate IC approvals renewals and submissions across stakeholders.
Provide IC training and support during investigator or coordinator meetings.

Document & Data Management

Maintain accurate and compliant IC documentation in the trial master file (TMF).
Perform audits of IC files for accuracy and regulatory completeness.
Track and report status updates using internal systems (CTMS eTMF).
Ensure all approvals and learnings are properly captured and stored.

Relationship & Process Management

Collaborate closely with study teams legal field clinical staff and contract analysts.
Build strong relationships with site coordinators and research center personnel.
Mentor junior ICS team members and support continuous process improvement.
Communicate SOP updates and provide compliance guidance to stakeholders.

Top Skills Required:

Proven experience managing and negotiating Patient Informed Consent (IC) within U.S. clinical research.
Strong document management and SOP adherence skills.
Effective relationship management across cross-functional and global teams.
Familiarity with IRB/EC processes clinical regulations and trial documentation standards.

Education & Experience:

Required: Bachelors in Clinical Research Biology Chemistry or related field.
Experience: Minimum 2 years working with informed consent/contracts in clinical research or advanced degree with no experience.
Preferred:
- 3 5 years in clinical study administration or related regulatory field.
- Juris Doctor or advanced degree in Clinical Administration.
- Multilingual (preferred but not mandatory).
- Strong understanding of clinical research compliance and regulations (FDA ICH-GCP).

Soft Skills:

Excellent communication and negotiation skills.
High attention to detail and organizational accuracy.
Strong documentation and audit-readiness mindset.
Ability to work independently and manage multiple concurrent projects.

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Job Title: Clinical Contract Analyst Client: Medical Device Manufacturing Company Duration: 2 Years (Possible Extension) Location: 100% Remote Shift: 1st Shift Position Overview: The Contract Analyst (Informed Consent Specialist) acts as the primary point of contact for managing and negotiating p...