Clinical Research Coordinator I
|Date Posted||April 29, 2018|
|Hours Per Week||40|
|PAVIR Job ID||ADM1809.18|
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 Research Coordinator (CRC) 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 CRC plays a critical role at every stage of clinical studies and will have the opportunity to grow in the research field. The CRC 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 CRC will have a key role in supporting and expanding different aspects of the clinical research program, 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.
- Perform pre-study feasibility assessment and study kick-off meeting with key stakeholders.
- Assist the CT Program Manager and coordinate with the Principal Investigator (PI) in the design of high-quality clinical trial budgets;
- Complete and coordinate study specific VA and PAVIR regulatory and compliance tasks to support rapid start up.
- Serve as primary contact for sponsors on administrative and regulatory issues, and triage as appropriate.
- Serve as a resource / trainer to other incoming study coordinators as needed.
- Complete all aspects of clinical trial registration as needed.
- Set up and maintain Trial Master Files (TMFs).
- Assist in the determination of guidelines for the collection of clinical data or administration of clinical studies.
- Assist in the preparation of protocols or modifications to study design.
- Assist with initial patient recruitment strategy and prepare associated materials for IRB submission.
- Coordinate the development of forms, questionnaires, and the application of research techniques.
- Coordinate and implement procedures for data collection from patient charts, medical records, interviews, questionnaires, diagnostics tests, and other sources.
Study Start Up:
- Coordinate collection of study documents (e.g. protocol signature pages, 1572s, PI CVs), schedule and attend Pre-Site Selection Visits (PSV) and Site Initiation Visits (SIV).
- Receive sponsor-specific training for Electronic Data Capture (EDC) system(s).
- Submit and assist with IRB submissions and coordinate responses to IRB requests for additional information;
- Draft ICF for PI review.
- Recruit, obtain informed consent, screen and enroll patient research subjects in suitable clinical trials. Review of Medical History of patients against Inclusion/Exclusion Criteria of studies.
- Review protocol and schedule of events to set up subject reimbursement.
- Manage coordination and logistics of receiving and shipping of study materials from and to the sponsor.
- 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.
- Schedule patient visits according to study protocol visit window and coordinator/investigator schedule.
- Performs Patient Visit Reminders, Visit Confirmations and/or Rescheduling of Visits.
- Ensure protocol adherence: understand, communicate and make sure the study parameters are ordered and carried out per protocol requirements.
- Meet with patient research subjects and perform visit requirements including scheduling collection of quality-of-life questionnaires, processing and shipping of laboratory and pathology specimens.
- Ensure that non-serious and serious adverse events are properly documented and reported as per protocol.
- Dispense study medication in a professional and accountable manner following protocol requirements.
- Screen all laboratory results when received and follow protocol procedure regarding abnormal results.
- Ensure scientific integrity of data and protect the rights, safety, and well-being of patients enrolled in clinical trials.
- Obtain, process and ship required specimens per protocol and transport specimens to coordinating research offices/lab as per protocol.
- Confirm all required data is collected and transferred to case report forms.
- Obtain all required source documentation.
- Schedule and set up for monitoring visits prior to monitor’s arrival.
- Complete all Case Report Forms (CRFs) and before all monitoring visits and address all queries generated during the monitoring visit.
- Help with the maintenance of TMFs for monitoring visits, final reconciliation and archival.
Regulatory and Compliance:
- Review protocols for compliance with accepted research guidelines and ensure compliance with protocol guidelines and requirements of regulatory agencies, HIPAA regulations, and special institutional policies of the VA and Stanford.
- Report any protocol violation/deviation to the PI, Sponsor & Regulatory Authorities per protocol guidelines.
- Assist PI in the initiation and renewal of IRB application and R&D Committee Submissions.
- Ensure the filing and maintenance of all regulatory documents.
- Prepare TMFs and subject charts for internal and external audits.
- 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.
- Prepare the EDC system for data lock.
- Manage tasks related to pharmacy and laboratory closeout activities including reconciliation of drug and temperature logs, shipment of unused collection kits.
- 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
Desired: CRC Certification
- Required: Two years of research-related experience or 1 year of experience specific to clinical-trial coordination plus certificate or equivalent in clinical trials education course(s)
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.
- Knowledge of following: Principles of Good Clinical Practice (GCP), Human Subjects Education, HIPAA, Bloodborne Pathogens, International Air Transport Association (IATA)
- Knowledge of IRB, FDA, and other sponsors requirements
- 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 VA and its health care system regarding clinical research trials and understanding of VA procedures and safety issues highly
Environmental Conditions / Physical Demands:
Physical: Lifting up to 10 lbs. occasionally, standing, bending, repetitive movement, etc.
Environmental: Exposure to an office/clinical environment and office equipment.
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.
- Medical Insurance
- Vision Insurance
- Dental Insurance
- Life Insurance – paid by PAVIR
- Long-term Disability Insurance – paid by PAVIR
- Short-term Disability Insurance – paid by PAVIR
- Flexible Spending Account
- Sick Leave
- 401(k) Retirement Plan with Company Match and Profit Share
- Employee Assistance Program
- Commuter Benefits