Clinical Trials Assistant
|Date Posted||June 20, 2018|
|Hours Per Week||40|
|PAVIR Job ID||ADM1808.18|
PAVIR engages in the administration of funds and providing support for the conduct of clinical research at the Veterans Affairs Palo Alto Health Care System (VAPAHCS) to find new and improved ways to combat human disease and help people with disabilities. We are currently seeking a Clinical Trials Assistant (CTA) to work under the supervision of PAVIR’s Clinical Trial Program Manager and serve under the guidance/direction of VAPAHCS Principal Investigators and their research staff.
This position will learn about and assist with the implementation of all new and ongoing studies. The CTA plays a critical role at every stage of clinical studies and will have the opportunity to grow in the research field. The CTA will be exposed to industry sponsors, will have direct interaction with prestigious Principal Investigators from different therapeutic areas, and will be exposed to all aspects of clinical operations of exciting clinical studies taking place at the VAPAHCS. The CTA will act as the administrative foundation in supporting different aspects of clinical studies, which includes facilitating clinical trials from inception, implementation, and closeout.
This is a regular (40 hours a week), non-exempt (hourly paid) position.
PAVIR is a nonprofit foundation affiliated with the Veterans Affairs Palo Alto Health Care System (VAPAHCS). As a condition of employment, all PAVIR employees are required to have an approved Without Compensation (WOC) appointment with VAPAHCS and complete a background check before they can commence work.
Study Start Up:
- Assist Clinical Research Coordinator (CRC) with collection of study documents (e.g. protocol signature pages, 1572s, PI CVs), scheduling and coordination of Pre-Site Selection Visits (PSV) and Site Initiation Visits (SIV).
- Receive sponsor-specific training for Electronic Data Capture (EDC) system(s) and serve as back-up to CRC for data entry.
- Review protocol and schedule of events to set up subject reimbursement schedule in online system.
- Assist with the coordination and logistics of receiving study materials from the sponsor.
- Ensure timely entry of subject visit data and respond to query resolution in sponsor-specific EDC system.
- Assist CRC in subject follow-up visit including scheduling collection of quality-of-life questionnaires, processing and shipping of laboratory and pathology specimens.
- Help with the maintenance of Trial Master Files for monitoring visits, final reconciliation and archival.
- Act as a central contact for the team for designated project communications, correspondence and associated documentation.
- Liaise between CRC, PI, and PAVIR Accounting for the reconciliation of subject reimbursement as needed.
Regulatory and Compliance:
- Assist CRC in the initiation and renewal of IRB application and R&D Committee Submissions.
- Prepare for internal and external audits.
- Address all queries generated during monitoring visits while monitor is on site.
- Maintain CT.gov registration records of clinical trials being conducted at VAPAHCS. Communicate with study staff for the timely entry of data in CT.gov and address queries as needed.
- Coordinate the study closeout visit with the sponsor.
- Assist the CRC prepare the EDC system for data lock.
- Help CRC with various administrative tasks related to pharmacy and laboratory closeout activities including reconciliation of drug and temperature logs, shipment of unused collection kits
- Assist the CRC closeout the IRB, R&D, and PAVIR accounting.
- Responsible for study record archival and tracking of materials sent to DataSafe per protocol.
- Maintain internal processes, including accurate qualitative and financial data input and data maintenance, participate in department activities and process improvement activities as appropriate.
- Contribute and help maintain Standard Operating Procedures for department and position.
- Required: Bachelor’s Degree in Biological Sciences or equivalent
- Required: 0 – 1 year of related experience;
Knowledge / Skills / Abilities:
During the interview you will be asked to perform a task or take a test for Aptitude/Analytical abilities and Clinical Research Knowledge. This will be used to assess candidates’ level of detail orientation and ability to extract complex information and apply it to specific case studies. Hiring decisions will not be solely based on the outcomes of this assessment, but will be used to help the selected candidate be placed and trained accordingly.
- Ability to prioritize and organize a high-volume workload and adapt to changing priorities
- Familiarity with standard concepts, practices, and procedures within the research field
- Excellent interpersonal, verbal, and written communication skills
- Outstanding organizational skills
- Ability to work independently
- Ability to assume responsibility for professional self-development
- Proficient with Microsoft applications (Word, Excel, and Outlook), mainframe computer applications, and database management
- Knowledge of IRB, FDA, and other sponsors requirements.
- Knowledge of VA and its health care system regarding clinical research trials and understanding of VA procedures and safety issues highly desired
Environmental Conditions / Physical Demands:
Physical: Lifting, standing, bending, repetitive movement, etc.
Environmental: Exposure to an office/clinical environment, office equipment, and some wet lab.
PAVIR engages in nonprofit medical research and works with sponsors and the Veterans Affairs Palo Alto Health Care System (VAPAHCS) in administering funds for conducting research to find new and improved ways to combat human disease and help people with disabilities. Please refer to our website for additional information: www.pavir.org
PAVIR is pleased to be an Equal Opportunity Employer for minorities, women, protected Veterans, and qualified individuals with a disability. If you need special assistance or an accommodation to apply for a posted position, please contact our Human Resources department.
- Sick Pay
- 401(k) Retirement Plan with Company Match and Profit Share
- Employee Assistance Program
- Commuter Benefits