Senior Clinical Research Associate

Role Objectives

The WEP Clinical Senior Clinical Research Associate (Senior CRA) oversees all aspects of clinical monitoring and site management in compliance with GCP, global regulatory requirements, and WEP Clinical SOPs. They conduct on-site and remote monitoring to ensure protocol adherence, maintain essential documentation, and keep site and patient data inspection-ready. The Senior CRA builds strong relationships with sponsors and sites, serving as a key point of contact throughout the study. They may also support development of study-specific procedures (e.g., Monitoring Plans) and assist in training or coordinating other CRAs.

Complex Study Experience Required

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%
• Able to remain in a stationary position for extended periods as part of normal day-to-day activities, with reasonable accommodations considered where appropriate

Location Eligibility

Candidates must reside in a U.S. state where the company is authorized to hire. This role is not eligible for residents of: California, Colorado, New York, Washington, New Jersey, Massachusetts, Illinois, Hawaii, and District of Columbia.

What We Offer

• Medical, dental, and vision insurance
• FSA, HSA
• Voluntary Critical Illness, Hospital Indemnity, and Accident Insurance
• Group short-term and long-term disability insurance
• Group Life Insurance
• 401K safe harbor plan and company match
• Paid vacation, holiday, sick and volunteer time
• Paid maternity & paternity leave

How We Work at WEP Clinical

We look for individuals who are conscientious, exercise sound judgment, and engage with others thoughtfully and professionally. We believe excellence is achieved through integrity, accountability, and respect for diverse perspectives - and we are committed to helping our people grow and succeed in an inclusive, supportive environment.

Our Services

• Access Programs
• Clinical Trial Services
• Patient Site Solutions
• Clinical Trial Supply
• Market Access and Commercialization
• Data Privacy Notice

Privacy Policy

WEP Clinical is committed to protecting your personal information throughout the recruitment process. By applying, you acknowledge that your personal data will be processed in accordance with our Privacy Policy and Job Applicant Privacy Notice.

How to Apply

To be considered for this role, please submit your resume through the WEP Clinical Careers Portal or by using LinkedIn’s Easy Apply option. Please ensure your resume is in English.