Clinical Research Coordinator I/II
|Date Posted||June 22, 2017|
|Hours Per Week||20|
|PAVIR Job ID||PAT1701.17|
The Palo Alto Veterans Institute for Research (PAVIR) is seeking a Clinical Research Coordinator position to support the clinical research of the VAPAHCS by overseeing assigned clinical research studies related to oncology.
The Research Coordinator’s duties involve coordinating studies, managing study participants, data collection, all regulatory compliance and IRB protocols, patient record organization, and reporting to sponsor, IRB, and VAPACHS.
This is a regular, non-exempt, part-time position with flexible hours (20 hours a week).
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 WOC appointment with VAPAHCS and complete a background check before they can commence work.
-Manage study participants:
- Read, understand and interpret study protocol
- Develop plan and implement patient recruitment strategy
- Identify and recruit study participant working
- May collect data through VA medical record review
- Prepare and maintain participant records and consent forms
- Explain the informed consent to participants
- Enroll potential subjects after obtaining informed consent
- Serve as point of contact for all enrolled participants
- Communicate with study subjects regularly via follow-up visits and telephone contact as per protocol
- Report adverse events in a timely manner
- Act as a liaison between the study subject and the physician concerning any problems or adverse reactions related to study medication or procedures.
-Manage data collection:
- Independently apply protocol approved study tasks, which may include preparing, distributing, administering and processing questionnaires and tests, scoring test measurements and questionnaires, and coding data for computer entry
- Evaluate, and interpret collected data and prepare appropriate documentation for sponsor and PI
- Perform quantitative review of forms, tests, and other measurements for completeness and accuracy, scheduling with other departments as applicable.
- Ensure data collection is compliant with protocol guidelines and requirements of regulatory agencies and sponsor requirements; may ship samples to collaborating sites
- Manage the database for internal and external audits and prepare summary reports.
-Complete administrative and other tasks:
- Perform all administrative tasks associated with assigned studies, including developing recruitment materials and requesting IRB approval
- Participate and provide status updates in research team meetings
- Manage administrative duties of each study.
-Maintain regulatory compliance:
- Prepare associated materials for IRB submission
- Manage all regulatory procedures for each study protocol, including compliance with all VA, Stanford University privacy and confidentiality regulations
- Independently respond to all sponsor queries
- Ensure compliance with all FDA regulations
- Submit and assist with local IRB submissions and coordinate responses to local IRB requests for additional information
- Review protocols and ensure compliance with protocol guidelines and requirements of regulatory agencies and HIPAA regulations
- Manage the study binder and serve as a point of contact for audits.
Required: BA/BS degree (or equivalent combination of education, training and experience) in health care, science, or in a related field
Desired: MA/MS/MPH degree in health care, science, or in a related field.
License / Certification:
- Clinical Trials Design and Management Certificate desired
- Phlebotomy certification desired.
Required: 2 or more years of experience in the conduct and coordination of clinical research
Desired: 5 or more years of experience in the conduct and coordination of clinical research.
Knowledge / Skills / Abilities:
- Strong knowledge of IRB, FDA, and other sponsors desired
- Strong knowledge of research procedures gained through education or experience
- Knowledge of VA and its health care system in regards to clinical research studies and ability to follow VA procedures and safety issues preferred
- Demonstrated experience recruiting subjects for clinical studies; Demonstrated ability to work with human study participants
- Familiarity and ability to apply standard concepts, practices, and procedures within the research field
- Excellent interpersonal, verbal, and written communication skills
- Strong organizational skills and ability to work independently and as part of a team
- Ability to assume responsibility for professional self-development
- Proficiency with Microsoft Word, Excel, and database software; Previous experience with statistical software desired;
- Strong computer skills and ability to quickly learn and master computer programs.
- Ability to use and apply analytical and mathematical skills effectively.
Environmental Conditions / Physical Demands:
Physical: Lifting up to 10 lbs occasionally, sitting, bending, standing, repetitive motion, etc.
Environmental: Exposure to office and hospital/clinical environment. Potential exposure to body fluids and bloodborne pathogens.
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, Females, Protected Veterans, and Qualified Individuals with a Disability. If you need special assistance or an accommodation to apply for a posted position, please contact email@example.com – Human Resources department.
- Sick Pay
- 401(k) Retirement Plan with Company Match and Profit Share
- Employee Assistance Program