Mentor, provide support and oversee CRAs, Senior CRAs and Lead CRAs (LCRA) Requirements
- Bachelor's degree required
- Clinical background or equivalency in clinical research experience
- Strong knowledge of medical terminology
- Strong written and verbal communication skills
- Strong computer skills • Moderate travel
- Supervisory and Leadership skills
- Good interpersonal skills
- Knowledge of FDA regulations/ICH guidelines
Supervision of CRAs, Senior CRAs and LCRAs Specific Job Duties
- Evaluate contract/ proposal to ensure proper staffing on overall project
- Work with Project Managers to ensure studies are adequately staffed.
- Ensure CRAs receive adequate training for specific job assignments.
- Ensure adherence to company policies and/or sponsor's SOPs.
- Work with staff and project team to plan and organize site monitoring.
- Ensure consistency with maintaining monitoring folders.
- Work closely with staff and project team to resolve monitoring issues.
- Report and discuss difficult personnel and/or site issues with Director and/or Project Management, as needed for possible resolutions.
- Work with CRAs to monitor workloads and make adjustments as needed
- Conduct performance appraisals and annual co-monitoring assessment visits for direct reports
- Conduct CRA staff interviews
- Working knowledge of all active protocols
- Attend applicable study team teleconferences/meetings
- Attend investigator meetings and provide support, as needed
- Ensure monitor visits occur per project schedule
- Ensure monitor visit reports and letters are of good quality, completed and submitted per UBC and client SOP
- Other duties as assigned
United BioSource Corporation (UBC) is a leading provider of pharmaceutical support services, partnering with life science companies to make medicine and medical products safer and more accessible. Our services support the full lifecycle of medicine and medical products, including development, commercialization, and long-term value and safety.
While UBC offers employment within Patient Support, Nursing, Pharmacy and Corporate, two main focus areas for the company are Clinical Development & Research and Safety & Risk Management. Members of the Clinical Development and Research teams help evaluate study protocol, target study population, recruit physicians and patients, and collect, clean, validate and report data. As a result, sponsors are able to submit findings to regulatory authorities or make a no-go decision in a timely and clear-cut manner. Additionally, our Safety and Risk Management teams develop, deliver, and report evidence to reinforce safe and appropriate product use.
Through our Patient Access services, we help patients begin therapy quickly and remain on therapy, building strong relationships with patients to ensure optimal care.
You can find out more by visitingwww.ubc.com