Qualification/Experience
- 2+ years of senior research coordinator experience.
- Methodical and strategic thinking.
- Project management skills
- Experience in budgeting and tracking expenditures for all study-related activities, including supplies and equipment.
- Knowledge of auditing policies.
- Must have documented experience of aiding at least one resident in design and completion of clinical research scholarly activity projects.
- Knowledge of the Health Insurance Portability and Accountability Act (HIPAA) and the ability to manage Protected Health Information (PHI).
- Experience administering and conducting the daily operation of clinical investigations including scheduling; supply and equipment needs, maintenance.
- Experience with developing and implementing a successful subject recruitment strategy and execution.
- Experience with developing Standard Operating Procedures (SOPs) for and maintain oversight and responsibility for all study data collection processes as outlined in IRB approved protocol.
- Experience with clinical research processes in reviewing case reports, coordinating the flow of information between case workers, Institutional Review Board (IRB), medical monitor and Principal Investigators (PIs), and handling case report forms in a secure manner.
- Experience with research data collection and records maintenance; clinical research processes in reviewing case reports, coordinating the flow of information between case workers, IRB, medical monitor and PIs, and handling case report forms in a secure manner.
- Experience with Occupational Safety and Health Administration (OSHA), Good Clinical Practices (GCP), Good Laboratory Practices (GLP), infection control procedures and rules and regulations pertaining to research sites.
- Experience explaining research protocols and obtaining signed consent from patients and research trial candidates as required per protocol.
- Experience with data collection procedures and research records maintenance.
- Proficient with creating, updating, and distributing content using Microsoft 365 e.g., Teams, Outlook, Word, Excel, PowerPoint.
- Must be detail oriented and able to work independently.
- Sufficient initiative, interpersonal relationship skills and social sensitivity such that they can relate constructively to a variety of people from diverse backgrounds.
- Excellent time management skills, able to work in a team environment and concurrently supporting several active projects.
- Strong oral and written communication skills.
Essential Duties and Responsibilities
- Coordinates with Principal Investigator (PI) and CID to help ensure that clinical research and related activities are performed in accordance with federal regulations and sponsoring agency policies and procedures.
- Assists the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to (but not limited to) protocol requirements, schedule of visits, execution of research plan. Maintains documentation of training.
- Assists Principal Investigator to assure that all key personnel or persons ‘engaged’ in the research project have met training requirements in accordance with federal regulations and sponsoring agency policies and procedures.
- Cooperates with NMCSD compliance and monitoring efforts.
- Assists the PI in study feasibility assessments as requested.
- Attends investigator meetings as required or requested by the PI.
- Collaborates with the PI to prepare IRB/HRPO and any other regulatory submission documents as required by the protocol.
- Prepares other study materials as requested by the PI. These study materials include, but are not limited to, the informed consent document, case report forms (CRFs), enrollment logs, and drug/device accountability logs.
- Establishes and organizes study files, including but not limited to, regulatory binders, study specific source documentation and other materials.
- Reviews and develops a familiarity with the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections.
- Assists PI in communication of study requirements to all individuals involved in the study. Provides appropriate training and tools for study team members. Documents date of training and signatures of study personnel trained on study specific training log.
- Collects documents needed to initiate the study and submit to the sponsor (e.g., FDA Forms 1572, CVs, etc.).
- Works with the PI to develop and implement recruitment strategies in accordance with requirements and approvals.
- Conducts or participates in the informed consent process including interactions with the IRB and discussions with research participants, including answering any questions related to the study. Obtains appropriate signatures and dates on forms in appropriate places. Assures that amended consent forms are appropriately implemented and signed.
- Screens subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or exclusion.
- Registers participants to the appropriate coordinating center (if multi-site study).
- Registers each participant in the billing matrix to ensure billing of study procedures to the appropriate funding source.
- Coordinates participant tests and procedures.
- Collects data as required by the protocol. Assures timely completion of Case Report Forms.
- Maintains study timelines.
- Completes study documentation and maintains study files in accordance with sponsor requirements and NMCSD policies and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms.
- Retains all study records in accordance with sponsor requirements and NMCSD policies and procedures.
- Maintains effective and ongoing communication with sponsor, research participants and PI during the study.
- Assists PI in preparation of any modifications to the scientific protocol in accordance with federal regulations and NMCSD and sponsoring agency policies and procedures.
- Works with the PI to manage the day-to-day activities of the study including problem solving, communication and protocol management.
- Promotes the ethical conduct of research by reporting good faith suspicions of misconduct in research as defined within NMCSD’s Research Integrity Policy and other misconduct as described in NMCSD’s Code of Conduct.
- Assists Principal Investigator with scientific and compliance reporting requirements in accordance with Federal regulations and NMCSD and sponsoring agency policies and procedures.
- Assists in the registration (if required) of the study at ClinicalTrials.gov and maintains current information on the site.
- Assists the Principal Investigator in submission of accurate and timely closeout documents to applicable federal agencies, NMCSD entities, and the sponsoring agency in accordance with federal regulations and NMCSD and sponsoring agency policies and procedures.
- Arranges secure storage of study documents that will be maintained according to NMCSD policy.
- Adheres to and supports all Federal regulations and NMCSD policies and procedures instituted to safeguard protected health information (PHI).
- Assists the Principal Investigator in promptly reporting any unanticipated problems involving risks to research participants or others.
- Assists the Principal Investigator in submission of accurate and timely closeout documents to applicable federal agencies, NMCSD entities, and the sponsoring agency in accordance with federal regulations and NMCSD and sponsoring agency policies and procedures.
- Arranges secure storage of study documents that will be maintained according to NMCSD policy or for the contracted length of time, whichever is longer.
- Works with Environmental Health and Safety to ensure that all facilities used follow all applicable regulations. Maintains copies of any applicable facility audits and equipment inspection/service reports.
Education/Certification Requirements:
- A Graduate degree in a healthcare related field is required.
Work Environment & Other Information:
- Location: Naval Medical Center San Diego, CA
- Telework schedule as approved by the direct supervisor.
- Background and employment checks are required.
- Must have proof of US citizenship.
- Active Public Trust or higher (preferred)
Job Types: Full-time, Contract
Pay: From $85,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Flexible schedule
- Health insurance
- Paid time off
- Vision insurance
Experience level:
Schedule:
Education:
Experience:
- Lead Clinical Research Coordinator: 2 years (Required)
- budgeting/tracking study-related expenses: 2 years (Required)
- Clinical Research: 5 years (Preferred)
License/Certification:
Security clearance:
Ability to Relocate:
- San Diego, CA 92134: Relocate before starting work (Required)
Work Location: In person