Skip to main content

Wepclinical

Senior Clinical Research Associate

United States +1

Location
United States · Morrisville, North Carolina, United States
Work
Remote
Employment
Full-time
Level
Senior
Function
Science & research
Pay
Not stated
Posted
13 months ago

About the role

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.

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/

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.

Important Note

To streamline our hiring process, we use an Upwage AI screener. If you receive a link from Upwage, it is a legitimate part of our application process and helps ensure every candidate is reviewed consistently. If you are selected to move forward after the screener, a member of our team will contact you directly from an @wepclinical.com email address to guide you through the next steps of the interview process. Please ensure you apply only through our official careers page (https://www.wepclinical.com/careers/) or our verified LinkedIn page.

For Your Safety, Please Note

We will never communicate with you via Microsoft Teams or text message

We will never ask for your bank account information at any stage of recruitment

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.

#LI-fulltime #LI-remote

Source

Posted by Wepclinical on their own hiring page, jobs.lever.co. OptiTalent shows it as published, read 07 Nov 2026 03:44 UTC; the original is the reference.

View the original ad ↗

More at Wepclinical

  • Responsible Person

    2 months ago

    Wepclinical · Dublin, Ireland

    On-siteFull-time

    The Responsible Person (RP) is an integral role within the company to ensure that EU Good Distribution Practice, national regulations, and provisions listed on the Wholesalers Distribution Authorisation are met and complied with at the company. The objective is to assure…

  • Wepclinical · Morrisville, North Carolina, United States

    HybridFull-timeSeniorEngineering

    The Site US Senior GMDP Quality Assurance Manager will provide senior leadership and accountability for the site quality assurance function supporting distribution and manufacturing activities, including secondary packaging and labelling. The role will oversee day-to-day site…

  • Wepclinical · Dublin, Ireland

    On-siteFull-timeManagerTrades & logistics

    The WEP Clinical cGMP Production Manager is responsible for both hands‑on execution and technical expertise of production, packaging, and labeling activities, ensuring compliant, efficient, and audit‑ready operations. The role oversees end‑to‑end GMP batch execution, including…

  • Wepclinical · United Kingdom

    RemoteMid level€1.00 an hourEngineering

    Job Description: As a Mobile Research Nurse, you will be crucial in ensuring the successful execution of research studies. You will be responsible for administering investigational medications/products, conducting patient assessments, collecting vital information, and adhering…