Description
Major Roles and Responsibilities of the CRA / LCRA:- Trip report review, management, resolution, and escalation
- Manages Clinical Monitor site assignments and schedules
- Conducts project co-monitoring visits and team training
- Provides project specific performance feedback
- Site contact for protocol clarifications and subject enrollment
- Protocol Deviation documentation, tracking, and escalation
- Oversees the development of study newsletters
- Relates project status to Project Manager
- Sponsor contact for monitoring/site issues
- Communicates project status and issues to Clinical Research Associates
- Responsible for coordination and management of the clinical monitoring budget and scope of work for monitoring activities
- Reviews and approves weekly project labor and pass through expenses for monitors
- Tracks monitoring services billing units and reports to Project Manager monthly
- Participates in Monthly Project Review meeting and provides budget projections for monitoring services units
- Ensures appropriate monitor staffing. Adds additional monitors and removes monitors through planned attrition according to budget projections
- Coaches/mentors monitoring team
- Develops project specific training materials for team
- Ensures project consistency within and across projects by following SOPs and/or Sponsor SOP and guidelines
Required Education and Experience of the Clinical Trial Manager/ LCRA:
- College graduate, preferably with a healthcare or life science degree; may require a BS, RN, or BSN degree or equivalent
- Minimum of 5 years of experience in monitoring clinical studies in the specified therapeutic area based on study assignment
- Must have current driving license and valid passport for those required to travel internationally
Required Technical and Behavioral Experience of the Clinical Trial Manager/ LCRA:
- Knowledge of regulatory requirements is required
- Familiar with a variety of the field's concepts, practices, and procedures
- Superior written and verbal communication skills
- Excellent interpersonal skills
- Possesses strong knowledge of GCP/ICH guidelines
- Proficient with Microsoft Office Suite Software, Internet Skills.
- Knowledge of medical terminology
- Ability to travel 10 - 20%
If you are interested in this role please send an up to date CV and call Hailey on . Please also pass this onto anyone else who may be suitable as we offer £200 referral vouchers.