Senior Clinical Research Associate

WEP Clinical Inc.; Morrisville (NC); Hybrid; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401K match

Paid vacation and holidays

Job summary

WEP Clinical is seeking a Senior Clinical Research Associate (Senior CRA) to oversee monitoring and site management under GCP and company SOPs. You will perform on-site and remote monitoring, ensure regulatory documentation, and maintain audit-ready site files.

You will train and coordinate CRAs, review study documents, and build strong sponsor-site relationships. This role may involve travel and requires a strong clinical research background.

Qualifications

• Bachelor’s degree in life sciences, nursing, or related field preferred.
• 5–7+ years’ experience conducting on-site and remote monitoring.
• Strong knowledge of GCP/ICH-GCP and regulatory requirements.

Responsibilities

• Design and review study documents (protocols, CRFs, ICFs, study plans).
• Lead site feasibility activities: questionnaires, responses, SQVs, site selection recommendations.
• Plan and conduct SIVs, monitoring, and close-out visits per protocol and ICH-GCP.

Skills

Leader

Detail Oriented

Problem Solver

Adaptable

Education

Bachelor’s degree in life sciences or related field

Tools

MS Office

EDC systems

Job description

Role Objectives

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) 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%


• Ability 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 Applies. 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, 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

What Sets Us Apart

WEP Clinical partners with biopharmaceutical Sponsors to help them bring treatments closer to the patients who need them most. Through end-to-end clinical trial delivery, home health services, expanded access programs, and market access consultancy, we provide flexible, fit-for-purpose solutions that support drug development, improve access, and help therapies reach the right patients at the right time. With more than 15 years of global experience, we have supported programs across 150+ countries, combining operational scale with the agility and personalized service of a specialized provider. Our work helps bridge critical gaps in care, ensuring safe, ethical, and efficient access to promising new treatments.

We’re Committed To Our Team

WEP has many initiatives to encourage wellness, growth and development, and team relationships.

How We Work At WEP Clinical

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.

Data Privacy Notice

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.

Privacy Policy: https://www.wepclinical.com/privacy-policy/

Job Applicant Privacy Notice: https://www.wepclinical.com/Job-Applicant-Privacy-Notice/

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.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.