Job Description – CRA – Site Manager
JOB DESCRIPTION
TITLE: Clinical Research Associate (CRA) – Site Manager
Company: Global BioClinical Location: Seattle, WA Type: Full Time with TravelDescription:
The Clinical Research Associate (CRA) – Site Manager will coordinate clinical studies and be responsible for all major stages of study development, execution, monitoring, and close-out.
Responsibilities will Include:
- Drafts materials including informed consents, case report forms (CRFs), CRF completion guidelines, and technical instructions.
- Carries out clinical site qualification, contract negotiation, IRB/ethical committee submissions, protocol initiation, site monitoring, and site close-out
- Coordinates and manages the activities of investigative sites to ensure compliance with study protocol requirements
- Ensures preparation, collection and distribution of trial master file (TMF) documents and maintenance of regulatory files at investigative site
- Conducts clinical site and data monitoring and completes monitoring visit reports
- Supports study supply, biospecimen delivery, and biospecimen testing logistics
- Evaluates clinical data and coordinates data query resolutions
- Supports internal departmental quality compliance
- Prepares progress reports and performance metrics
- Required travel to investigative sites up to 10%
Skills and Qualifications:
Clinical Research Competencies:
- >2 years clinical site management and monitoring experience
- Understands and can apply knowledge of clinical trial designs to trial execution
- Advanced knowledge and experience with GCP/ICH and local regulations
- Experience in web-based data collection applications, knowledge of key areas for compliance
Non-Clinical Experience:
- Strong communication skills as single point of contact for investigator
- Excellent organizational skills with high attention to detail is required
- Strong computer skills (spreadsheets, word processing, etc) is required
- Ability to manage, prioritize, and routinely report progress on multiple projects and tasks
- Strong skills in building and maintaining relationships with investigative sites
- Strong presentation skills to internal professionals and external collaborators
Send Resumes to: careers@globalbioclinical.com