Clinical Research Coordinator – Cooperative Studies Program

PAVIR•Stanford, CA

4d•Onsite

About The Position

Palo Alto Veterans Institute for Research (PAVIR) is seeking a full-time Clinical Research Coordinator (CRC) to support the nation's second largest research program among VA Hospitals. The CRC will be responsible for participant recruitment and enrollment, coordination of study activities, data collection and analysis, documentation, meeting reporting requirements, and providing oversight to study activities under the site PI's authority. The CRC ensures all protocols adhere to Federal and VA guidelines, are auditable for compliance, are closed out and archived properly, and all research activities are documented as required. Regular communication with the PI and/or Supervisor regarding study progress and results is expected. The CRC will act as an advisor and technical expert to research and administrative staff, interpreting regulations, policies, and procedures, and providing guidance on documentation, reporting, annual reviews, and project closure. The CRC will manage and oversee the day-to-day operations of complex clinical research to ensure adherence to study protocols, including regulatory compliance, study conduct, and Good Clinical Practice (GCP). The CRC is responsible for the accuracy and completeness of all local site documentation and records in the Investigator Study File and electronic medical records.

Requirements

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
Demonstrated ability to work independently and cooperatively
Demonstrated ability to work and communicate effectively with study subjects
Proven track record towards meeting goals and deadlines
Strong interpersonal skills
Proficiency with Microsoft Office and database applications

Nice To Haves

Knowledge of VA and its health care system regarding clinical research trials and understanding of VA procedures and safety regulations
Knowledge of and experience working in orthopedic research
Knowledge of medical terminology

Responsibilities

Development of Program Evaluation Policies and Procedures
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 PI 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.
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.