Job Listing
Senior Clinical Research Associate
Job Type
Permanent
Employment
Full Time
- Extensive Knowledge of FDA regulations and their practical implementation
- Manage and track the preparation and return of investigational supplies at individual sites
- RN or Bachelor and/or advanced degree in biological sciences or related field
- Paying up to high $130’s
Job Responsibilities
- Monitor clinical studies of investigational and approved products that have been determined to satisfy a medical need and/or offer a commercial benefit. This may include the following site visits: qualification, initiation, interim, and close out
- Manage and train site personnel on therapeutic area, protocol requirements, proper source documentation, and case report form completion
- Manage and track the preparation and return of investigational supplies at individual sites
- Monitor and document investigational product dispensing, inventory, and reconciliation
- Monitor and document laboratory sample storage and shipment
- Monitor trial by reviewing and reporting on the following: site enrollment and termination updates, monitoring visits, protocol deviations/exceptions, serious adverse events, and laboratory abnormalities
- Review source data and case report forms for accuracy, completeness, and integrity of the data, and identify and resolve ongoing data issues
- Review data queries and listings, and work with study centers to resolve data discrepancies
- Review regulatory documentation for accuracy and completeness, and support study centers with regulatory issues
- Maintain complete and accurate study files and review files to ensure all appropriate documentation is present
- Maintain consistent and timely contact with the study centers, investigators, coordinators, client personnel, and other individuals involved in clinical trials
- Serve as a resource for project team members including supporting CRA I and CRA II staff by providing solutions to resolve issues
Qualifications
OTHER QUALIFICATIONS
- Detail-oriented
- Excellent organizational skills, strong interpersonal and communications skills, and strong problem-solving skills
- Flexibility with changing priorities
- Ability to efficiently perform and prioritize multiple tasks
- Familiarity with the medical and pharmaceutical industries, and related terminology and practices
- Extensive knowledge of FDA regulations and their practical implementation
- Ability to travel, including by air or by car on short notice
- Computer proficiency in Microsoft Word, Excel, and PowerPoint
EDUCATION AND/OR EXPERIENCE
- RN or Bachelor and/or advanced degree in biological sciences or related field, or equivalent combination of relevant experience, education or training, and previous CRA experience demonstrating career growth in the CRA position
