Sr. Clinical Monitor
6000 Shoreline Court Suite 304 South San Francisco, CA 94080
Sr. Clinical Monitor
Commutable to Costa Mesa, CA or SF Bay Area (in SSF office 1-2 times per week)
50% Travel Requirement
- Monitoring 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.
- Managing and training of site personnel on therapeutic area, protocol requirements, proper source documentation, and case report form completion.
- Managing, preparing, sending, tracking, and returning investigational supplies at individual sites.
- Monitoring and documenting investigational product dispensing, inventory, and reconciliation.
- Monitoring and documenting laboratory sample storage and shipment.
- Monitoring trial by reviewing and reporting on the following: site enrollment and termination updates, monitoring visits, protocol deviation/exceptions, serious adverse events and laboratory abnormalities.
- Reviewing source data and case report forms for accuracy, completeness, and integrity of the data, and identifying and resolving ongoing data issues.
- Reviewing data queries and listings, and working with the study centers to resolve data discrepancies.
- Reviewing regulatory documentation for accuracy and completeness, and supporting study centers with regulatory issues.
- Maintaining complete and accurate study files and reviewing files to ensure all appropriate documentation is present.
- Maintaining consistent and timely contact with the study centers, investigators, coordinators, client personnel, and other individuals involved in clinical trials.
- Other tasks or responsibilities as assigned.
- Attention to detail.
- Flexibility with changing priorities.
- Excellent organizational skills.
- Ability to efficiently perform and prioritize multiple tasks.
- Ability to identify and take initiative to solve logistical problems.
- Effective verbal and written communication skills.
- Ability to work effectively both independently and on a diverse team.
- Familiarity with medical and pharmaceutical industry, and related terminology and practices.
- Appropriate knowledge of FDA regulations and their practical implementation.
- General computer skills (PC based) with proficiency in Microsoft Word, Excel, and Outlook.
- Ability to work efficiently on the computer, including document retrieval, review, and tracking.
- Ability to travel, including air travel, on notice as short as 24 hours, maintaining efficient and effective travel schedules.
- Must have a valid driver' s license, a good driving record, and up-to-date car insurance.
EDUCATION AND/OR EXPERIENCE
- Bachelors and/or advanced degree in biological sciences or related field
- Equivalent combination of relevant experience, education, and previous 5yrs CRA monitoring experience.