- 31-Jan-2013 to 30-Nov-2013 (PST)
- Clinical Research
- Sunnyvale, CA, USA
- Full Time
An employee working in the Lead Clinical Research Associate role may be located in-house at ProTrials HQ or a client, or be regionally based. This person will be responsible for tasks that relate to the operations and management of clinical trials. The Lead Clinical Research Associate may be involved in some or all of the tasks listed below:
1. Monitoring clinical studies of investigational and approved products. This may include qualification, initiation, interim monitoring, and close out site visits.
2. Acting as primary liaison between the study site staff and sponsor company.
3. Monitoring studies by reviewing and reporting to the Sponsor on the following: site enrollment and subject status, findings at monitoring visits, protocol deviations/exceptions, serious adverse events and laboratory abnormalities.
4. Reviewing source data and case report forms for accuracy, completeness, and integrity of the data, and identifying and resolving ongoing data issues.
5. Reviewing investigational product accountability, including discrepancy resolution.
6. Processing or overseeing transmission of study data to sponsor according to protocol-specified timelines.
7. Reviewing data queries and listings, and working with the study site staff to resolve data discrepancies.
8. Overseeing the study site staff to assess protocol compliance and appropriate data collection including proper handling, storage and shipment of biological samples.
9. Maintaining consistent contact with the study site staff, including investigators, coordinators, client personnel, and other individuals involved in the clinical study.
10. Visit report writing and site correspondence.
11. Training of site personnel on therapeutic area, protocol requirements, proper source documentation, and case report form completion.
1. Managing the preparation, collection and maintenance of trial regulatory documents.
2. Maintaining complete and accurate study files, and reviewing files to ensure all appropriate documentation is present.
3. Managing, preparing, sending, tracking, and returning investigational supplies at individual sites.
4. Managing investigational product ordering, packaging, labeling and ongoing inventory.
1. Managing the reporting of serious adverse events.
2. Developing study-related documents such as: protocols, case report forms, informed consent forms, study binders, standard operating procedures, study guidelines, study management/tracking tools, and monitoring plans.
3. Preparing contracts with investigators/hospitals, and negotiating budgets and payment schedules.
4. Planning, preparing for, and giving presentations at investigator meetings.
5. Development and management of study timelines.
6. Assisting with medical writing and regulatory submissions, such as interim, final study, and annual progress reports. Developing or updating Investigational Product Brochures. Preparing documentation for regulatory submissions (IND, NDA, BLA, IDE, PMA).
1. Visit report writing and site correspondence.
2. Interacting with project manager (sponsor or other) through formal and informal communications, including providing updates, identifying issues, sharing of information and instructions.
3. Managing the resource requirements of the project.
4. Supervision and guidance of CRAs, CR Assistants, and external CROs. Conduct of co-monitoring, training and audit visits. Creation of visit report templates. Review of completed visit reports.
5. Managing all aspects of the implementation of a clinical study.
6. Interdepartmental liaison working with regulatory, data management, biostatistics and clinical groups to develop and maintain clinical plan.
7. Selection and management of outside vendors, such as CROs, DM groups, investigational product packaging, central laboratories.
• RN or BS degree in biological sciences or related field or equivalent combination of education and experience: 4 or more years successful CRA experience.
• Detail oriented.
• Excellent organizational skills, strong interpersonal and communications skills, and strong problem solving skills.
• Familiarity with medical and pharmaceutical industry, and related terminology and practices.
• Extensive knowledge of FDA regulations and their practical implementation.
• Willingness to travel.
• Computer proficiency in Microsoft Word, Excel, and Powerpoint.
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