Clinical Research Associate I/II (CRA I/II) – Morrisville, NC, USA
The Clinical Research Associate I/II (CRA I/II) performs and coordinates all aspects of the clinical monitoring and site management process in accordance with ICH Good Clinical Practices, FDA guidelines, local regulations and WEP Clinical Standard Operating Procedures.
This position requires proven monitoring skills. The CRA I/II conducts site visits to assess site adherence to protocol and regulatory requirements as well as manages required documentation. The CRA I/II will also be responsible for ensuring the data remains audit ready and able to pass an audit by WEP Clinical, the Sponsor or a regulatory agency.
The CRA I/II will be a part of a multi-disciplinary team that provides scientific, statistical, operations, and management support for commercially or federally funded clinical trials.
Responsibilities
Responsibilities and duties include, but are not limited to:
- Perform all site monitoring visit activities, inclusive of all study visit types (PSV, SIV, IMV and COV)
- Participate in the site selection process
- Provide feedback to assist sites with resolution of detected deficiencies and corrective action needed, follow-up with sites until deficiencies are resolved
- Contribute to the development of protocols, study tools, and materials as well as documentation for clinical trials
- Provide mentoring, training, and co-monitoring of junior clinical team members
- Develop and maintain effective working relationships with clinical sites, with sponsors, and within WEP Clinical as well as ensure communication of project goals and critical requirements
- Participate in the Clinical Operations community at WEP Clinical by contributing to internal initiatives and standard operating procedures for the administration and monitoring of clinical trials
- Perform both onsite & remote monitoring and study activation and closure activities across multiple protocols
- May participate in drafting Clinical Monitoring Plans and Templates
Qualifications
Minimum Requirements:
- Approximately 2-5 years of on-site monitoring experience
- BA/BS, preferably in a life science, nursing, pharmacy or related field
- Clinical background preferred
- Broad range of therapeutic experience
- Proficient technical/scientific knowledge required for comprehension and execution of clinical protocols
- High organizational and logistics skills to ensure effective management of multiple sites and protocols within timeframes and on budgets
- Superior written and verbal communication skills
- Demonstrate an understanding of medical/therapeutic area knowledge and medical terminology
- Demonstrated ability to train and mentor clinical research staff
- Computer literacy, including proficiency in MS Office and use of EDC systems
Benefits
- Medical, dental, and vision insurance
- Short-term and long-term disability insurance
- Voluntary life insurance
- 401K safe harbor plan and company match
- Paid vacation, holiday and sick time
- Remote/work from home opportunities
- Flex hours available
- Employee outings
- Collaborative office environment
Job Type: Full-time
Location:
- Morrisville, NC, USA