Lead Clinical Research Associate
WEP Clinical
Full-time
Remote
United States
Science & Research
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 Lead Clinical Research Associate (CRA) supervises, performs and coordinates all aspects of the clinical monitoring and site management process in accordance with ICH Good Clinical Practices, FDA/MHRA/EMA guidelines, local regulations and WEP Clinical Standard Operating Procedures.
The Lead CRA is responsible for ensuring the effective and efficient delivery of clinical site monitoring, regulatory requirements, and managing required documentation. Additionally, the Lead CRA provides project-level oversight to In-House CRAs and/or CRA I/II ensuring the smooth execution of monitoring activities for clinical trials and Expanded Access Programs (EAP).
The Lead CRA will be a part of a multi-disciplinary team that provides scientific, statistical, operational, and support for clinical trials and EAPs.
The Ideal Candidate:
- Leader
- Detail Oriented
- Problem Solver
- Adaptable
What You'll Do:
- Provide guidance, oversight, and performance assessment for In-House CRAs and CRA I/II, including co-monitoring visits and on-site training.
- Oversee monitoring activities for clinical trials and Expanded Access Programs (EAPs), ensuring compliance with protocols, SOPs, and regulatory requirements.
- Review, approve, and provide guidance on monitoring visit reports, including resolution of complex and escalated issues.
- Collaborate with Cross-Functional Team Leads to support successful project execution and alignment across departments.
- Assist in resource planning and workload distribution within the Clinical Monitoring Department.
- Contribute to the creation and implementation of monitoring strategies, plans, and required documentation (e.g., Monitoring Plans, Visit Reports, Action Item Logs).
- Identify, assess, and escalate potential project risks or issues in a timely manner.
- Ensure accurate and timely data entry in clinical trial management systems (CTMS) and other project trackers.
- Support CRA recruitment, onboarding, and training, while staying current with industry trends and best practices.
- Participate in sponsor meetings, audits, and contribute to the development and ongoing revision of company SOPs.
What You'll Need:
- 6+ years’ experience coordinating on-site and remote monitoring visits
- Bachelor's Degree (in a health, nursing or science field preferred)
- Broad range of therapeutic experience
- Highly proficient technical/scientific knowledge required for comprehension and execution of clinical protocols
- Highly proficient organizational and logistical skills to ensure effective management of multiple sites and protocols within timeframes and on budget
- Highly effective written and verbal communication skills
- Demonstrate a strong understanding of medical/therapeutic area knowledge and medical terminology
- Experience training and mentoring staff
- Computer literacy, including proficiency in MS Office and use of EDC systems
- Willingness to travel up to 50%
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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