Senior Clinical Research Associate
Remote, US
Monitoring – Monitoring /
Full-Time /
Remote
Are you looking for an exciting and fulfilling new position? Join our dynamic team at WEP Clinical, where your contributions will play a key role in driving impactful solutions and improving outcomes for clients and patients. We encourage innovation and collaboration, challenging our team to bring forward ideas that make a real difference. Be part of a mission-driven organization dedicated to advancing clinical research and transforming lives.
Role Objectives:
The WEP Clinical Senior Clinical Research Associate (Senior CRA) performs and coordinates all aspects of clinical monitoring and site management in compliance with ICH Good Clinical Practice (GCP), FDA/MHRA/EMA guidelines, local regulations, and WEP Clinical Standard Operating Procedures (SOPs).
The Senior Clinical Research Associate performs on-site and/or remote monitoring visits to assess site adherence to protocol and regulatory requirements, manages essential documentation, and ensures that patient and site data remain inspection-ready for WEP Clinical, Sponsors, and regulatory agencies. In addition, the Senior CRA develops and maintains strong relationships with sponsors and clinical sites, serving as a trusted point of contact throughout the study lifecycle.
The Senior Clinical Research Associate may also contribute to developing study-specific procedures and documents, such as the Clinical Monitoring Plan, and may train and coordinate other CRAs within the clinical monitoring team.
The Ideal Candidate:
- Leader
- Detail Oriented
- Problem Solver
- Adaptable
What You'll Do:
- Contribute to the design and review of study documents (protocols, CRFs, ICFs, and study plans).
- Lead site feasibility activities: distribute/collect questionnaires, evaluate responses, conduct SQVs, and recommend sites for selection.
- Planned and conducted SIVs, routine monitoring, and close-out visits in line with protocol, ICH-GCP, and regulatory requirements.
- Build strong relationships with site staff; deliver training and ongoing guidance on protocol compliance and regulations.
- Verify source data and CRFs for completeness, accuracy, and consistency; always keep site files audit-ready.
- Review IP accountability, safety event documentation, and protocol deviations; drive corrective and preventative actions.
- Manage and resolve data queries, analyze error trends, and provide targeted retraining to prevent recurrence.
- Track and close action items within study or company timelines; maintain clear oversight of monitoring deliverables.
- Support investigator meetings and key internal/external meetings; contribute to SOPs, monitoring tools, and templates.
- (Lead CRA, if assigned) Oversee monitoring on complex studies; develop study-specific monitoring documents (e.g., CMP, deviation plan, report templates); finalize visit reports; train/coordinate CRAs; act as primary clinical monitoring contact for PM/Sponsor and handle CRA escalations.
What You'll Need:
- Bachelor’s degree (life sciences, nursing, or related field preferred).
- 5–7+ years’ experience conducting on-site and remote monitoring visits (or equivalent clinical research experience).
- Senior CRA levelling: SCRA I (3–5 yrs) – independently manages complex sites; SCRA II (5+ yrs) – oversees complex sites/regions, mentors peers, and drives process improvements.
- Broad therapeutic exposure across multiple study types and indications.
- Strong technical/scientific aptitude with the ability to quickly grasp and execute clinical protocols.
- Advanced organizational and logistical skills; able to manage multiple sites/protocols within budget and timelines.
- Excellent written and verbal communication; confident stakeholder engagement.
- Solid understanding of medical/therapeutic areas and medical terminology.
- Proven ability to train, coach, and mentor clinical research staff.
- Proficient with MS Office and EDC systems; willing to travel up to 80%.
What We Offer:
Medical, dental, and vision insurance, FSA, HSA
Voluntary short-term and long-term disability insurance
Voluntary life insurance
401K safe harbor plan and company match
Paid vacation, holiday, and sick time
Paid maternity & paternity leave
What sets us apart:
WEP Clinical partners with sponsors to help patients and physicians gain early access to medicines when no other treatment options are available. WEP Clinical has over 15 years of experience distributing products to over 120 countries worldwide to treat unmet patient needs.
We're Committed to Our Team:
WEP has many initiatives to encourage wellness, growth and development, and team relationships. Check out our LinkedIn Life Page to learn more about our team events, and all that we do to support our employees.
We're Committed to DEI:
At WEP Clinical, acceptance, recognition, and engagement are the core of our DEI values. We are committed to giving employees opportunities for personal and professional success and growth, embracing everyone's unique identities.
Our services include:
Access Programs
Clinical Trial Services
Patient Site Solutions
Clinical Trial Supply
Market Access and Commercialization
WEP Clinical is a smoke-free, drug-free, and alcohol-free work environment.
WEP Clinical is an equal-opportunity employer. WEP Clinical does not unlawfully discriminate against employees or applicants for employment based on an individual’s race, colour, religion, creed, sex, sexual orientation, gender identity or expression, national origin, genetic information, age, disability, marital status, veteran status or any other status protected by applicable law. This policy applies to all terms, conditions, and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination. WEP Clinical will make reasonable accommodation for qualified individuals with known disabilities, in accordance with applicable law.
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