Clinical Research Coordinator Cooperative Studies Program

Clinical Research Coordinator Cooperative Studies Program

Palo Alto Veterans Institute for Research (PAVIR) supports the nation's second largest research program conducted among the VA Hospitals and is looking for a full-time Clinical Research Coordinator (CRC). The CRC is responsible for participant recruitment/enrollment, coordination of study activities, data collection, analysis of data and project activities, documentation of activities, meeting reporting requirements, and providing oversight to study activities under the site Pl's authority. The CRC ensures that all protocols adhere to Federal and VA guidelines and requirements; are able to be audited for compliance with applicable research policies and regulations; are closed out and archived properly; and all research activities are documented as required by the specific protocol. Regular written and oral communications to the Pl and/or Supervisor describing study progress and results will be required.

The CRC serves as an advisor and technical expert to research and administrative staff, interpreting the regulations, policies, procedures, and practices governing the conduct of research, and providing guidance on documentation of progress, financial and administrative reporting requirements, annual review, and project closure and archiving.

The CRC will manage and oversee the day-to-day operations of complex clinical research to assure adherence of study protocol, including all actions related to regulatory compliance, study conduct, and Good Clinical Practice (GCP). The CRC will be responsible for accuracy and completeness of all local site documentation and records in the Investigator Study File (all records and materials pertaining to the clinical research study, including participant files and related correspondence and regulatory documents) and electronic medical records.

PAVIR offers generous benefits, including comprehensive health insurance, vision, dental, 14 paid holidays, paid vacation time, sick pay, a 401(k) with a fully vested 6% company match and 3% profit share, a wellness program, commuter benefits, and professional development training. Plus, we pay for life, short-term disability, and long-term disability insurance.

JOB RESPONSIBILITIES

• Develops policies, procedures and criteria for administration of the organization's health science research program Standard-of-Procedures (SOP), including scheduling and conducting research participant visits, clinical communication templates, safety reporting, data entry and data capturing methods, maintenance of regulatory documents, preparing for monitoring visits, etc.
• Reviews regular project status reports and statistical data to verify compliance with research reporting and administrative criteria.
• Prepares consolidated reports (e.g., monthly status/recruitment/quality metric reports, annual continuing reviews, responding to data queries, payment reimbursement accounting, protocol deviation, resolve tracking log discrepancies, personnel training adherence, etc.) for management, Sponsor, and higher echelon review.
• Establish program goals and objectives and identify results indicative of successful program accomplishments.
• Assist specialists with establishing acceptable research policies and procedures for evaluation groups to conduct their reviews and to frame their recommendations for project effectiveness.
• Assist in providing guidance to others in analyzing research and to determine the appropriate kind of review.

Recruitment of Candidates for Clinical Trials

• Oversee, screen, and evaluate recruitment of candidates for clinical research studies via telephone and/or in person.
• Use objective rating techniques to identify potential candidates for participation in study where project design is complex.
• Oversee recruitment and enrollment of participants, providing information on study objectives and constraints.
• Perform informed consent process throughout the study and continuously educate participants on study processes and procedures.
• Obtain verbal and/or written informed consent, Health Insurance Portability and Accountability Act (HIPAA) authorization, and background demographic information (as needed) from patients ensuring that the process adheres to HIPAA, information security and other federal regulations regarding confidentiality and the conduct of human subjects' research.

Management of Clinical Tests

• Manage implementation, control and reporting on clinical tests.
• Implement data collection and monitor protocols for difficult clinical research studies.
• Administer or monitor administration of tests and measurements required by project design.
• Record data from samples and specimens to ensure that all tracking data is organized and is monitored during the progress of the study.
• Identify test results and trends requiring further analysis.
• Maintain all study and regulatory records.
• Prepare project and statistical reports for review process.
• Coordinate the accomplishment of the scientific (merit) review and evaluation of research programs to provide recommendations or decisions for program strategies, modifications, budgeting, or improvements.

Data Collection Management

• Participate in initial classification and coding of qualitative/quantitative data and entering coding data into qualitative/quantitative software.
• Participate in activities preparing for, and subsequent to, collection of study data.
• Assist with data analysis from a variety of sources, including databases and spreadsheets, and conceive and write reports as needed.
• Monitor data collection processes ensuring data integrity and completeness.
• Help respond to inquiries from a sponsor, clinical research coordinating center and/or site Pl on matters related to data, data compliance, and subject complaints related to data collection.
• Help ensure that data collection and transmission activities are compliant with applicable data security and privacy policies.
• Summarize research data using computerized programs (e.g., Microsoft Office)

Management of Research Project Administration and Evaluation

• Manages the routine, day-to-day activities, and administration of the project.
• Plan, develop, complete, and submit on time all required documentation/paperwork/forms for initial and continuing human subjects' review.
• Analyze processes and documentation to ensure compliance with all technical, regulatory requirements, and information safety regulations.
• Regularly review guidance, policies, and procedures to maintain regulatory compliance
• Conduct quality assurance evaluations for project data and clinical research instruments, as applicable.
• Establish and monitor remediation plans to correct deficiencies.
• Provide technical guidance to research staff regarding regulations, policies, and procedures applicable to the conduct of research.
• Technical guidance may require understanding resources and/or appropriate individuals from whom to obtain needed information to be applied in the context of a study
• Monitor project progress and timelines as required.
• Independently respond to general inquiries from program participants, staff, and other stakeholders.
• Independently draft correspondence and general communications regarding the program, including memorandums and reports.
• Schedule meetings, including scheduling meeting space, notifying participants, preparing the agenda and minutes and following-up on all commitments to ensure that necessary arrangements have been made.
• Assist in determining whether funds are being expended in accordance with study goals and budgets.
• Assist in the development of clinical research standard operating procedures and policies including those ensuring the protection of human subjects.
• Assist in the development and implementation of administrative procedures to comply with all applicable regulations.
• Draft detailed and summary reports for presentation at meetings and conferences and for publication in peer reviewed journals.
• Compile and produce educational and training materials; determines contents needed for training binders and tools; oversees production of the educational and/or training tools and materials.
• Organize and maintain all study documents for management, data, record keeping and/or compliance purposes.
• Administers screening, advisory and approval processes for the organization's health science research program.
• Prepares information for research project evaluation functions.
• Gathers statistical and narrative data on project status, including resource utilization, statistical data on participation, adherence to protocols on matters such as participant education, control of data, and other similar matters.
• Arranges data in formats required by review process.
• Performs a variety of duties to maintain specialized data and implement study design.
• Performs other related duties as outlined in the specific research protocols.
• Other tasks as assigned.

QUALIFICATIONS

• Required: Bachelor's degree or equivalent experience;
• 6 months or more of relevant experience;
• Valid Driver License required.
• Good understanding of clinical terminology and procedures gained through experience;
• Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices;
• Ability to read and understand study/trial protocol;
• Ability to prioritize and organize a high-volume workload and adapt to changing priorities;