Description
We are seeking a Clinical Research Coordinator to serve as a Single Point of Contact (SPOC) for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary.
The successful candidate will ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables, and project timelines.
Key responsibilities include:
- Performing start-up and site activation activities according to applicable regulations, SOPs, and work instructions
- Preparing site regulatory documents, reviewing for completeness and accuracy
- Ensuring accurate completion and maintenance of internal systems, databases, and tracking tools with project-specific information
- Reviewing and providing feedback to management on site performance metrics
- Establishing and agreeing on project planning and project timelines
- Informing team members of completion of regulatory and contractual documents for individual sites
- Reviewing, tracking, and following up on progress, approval, and execution of documents
- Providing local expertise to SAMs and project teams during initial and ongoing project timeline planning
- Performing quality control of documents provided by sites
- May have direct contact with sponsors on specific initiatives
Requirements:
- Bachelor's degree in a related field
- 1 year of clinical research experience or equivalent combination of education, training, and experience
- In-depth knowledge of clinical systems, procedures, and corporate standards
- Strong knowledge of medical terminology and regulations
- Broad knowledge of clinical research
- Strong knowledge of Microsoft Office and email applications
- Effective communication, organizational, and interpersonal skills
- Ability to work independently and prioritize tasks
- Ability to manage multiple projects
- Attention to detail
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients