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Senior Clinical Research Associate (Cell & Gene Therapy)

Key Facts

Remote From: 
Full time
Senior (5-10 years)
English

Other Skills

  • Communication
  • Teamwork
  • Problem Solving
  • Adaptability

Roles & Responsibilities

  • 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)
  • Strong technical/scientific aptitude with the ability to quickly grasp and execute clinical protocols
  • Proficient with MS Office and EDC systems; willing to travel up to 80%

Requirements:

  • Oversee all aspects of clinical monitoring and site management in compliance with GCP and regulatory requirements
  • Conduct on-site and remote monitoring to ensure protocol adherence and maintain essential documentation
  • Build strong relationships with sponsors and sites, serving as a key point of contact throughout the study
  • Support development of study-specific procedures and assist in training or coordinating other CRAs

Job description

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.
Cell and Gene Therapy 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, 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
     
    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. Check out our LinkedIn Life Page to learn more about our team events and all we do to support our employees. 
     
    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. 
     
    Our Services Include:
    Access Programs
    Clinical Trial Services
    Patient Site Solutions
    Clinical Trial Supply
    Market Access and Commercialization
     
    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.
     
    Job Applicant Privacy Notice: https://www.wepclinical.com/privacy-policy/ 
     
    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

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