Senior Clinical Research Coordinator - San Diego, United States - Odyssey Systems

Description

Position Summary:

Odyssey is looking for a Senior Clinical Research Coordinator to support researchers in the performance of moderately complex research and experimentation for the Clinical Investigations Department (CID) , Directorate for Professional Education at Naval Medical Center San Diego (NMCSD) and 14 additional DHA mandated sites.

***Contingent upon contract award***

Duties include, but are not limited to:

• Coordinates with Principal Investigator 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 participants 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 NMCSDs Research Integrity Policy and other misconduct as described in NMCSDs 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 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.

***Contingent upon contract award***

Minimum Required Qualifications:

Citizenship: Must be a US citizen

Clearance: None

Education: Graduate degree in a healthcare related field is required

Years of Experience: 2+ years of senior research coordinator experience

Skills:

• Methodical and strategic thinking.
• Project management skills
• Budgeting and accounting experience.
• Computer literacy.
• Knowledge of auditing policies.
• Strong writing skills.
• Proficient with MS Office Word and Excel.
• Excellent communication skills, both verbal and written.
• Ability to meet deadlines.
• Must have documented experience of aiding at least one resident in design and completion of clinical research scholarly activity project.
• Knowledge of the Health Insurance Portability and Accountability Act (HIPAA) and the ability to manage Protected Health Information (PHI).

Additional Information:

Location: San Diego, CA

Travel: up to 10%

Remote, Onsite, or Hybrid: Onsite

***Contingent upon contract award***

#LI-AS1

Odyssey Systems Consulting Group, is an innovative small business committed to providing world-class technical, management, and training support services to government and public sector clients. We focus on people, processes, and performance to deliver superior results. Since our inception in 1997, our commitment to mission success and customer satisfaction has been recognized with exponential growth and exceptional past performance ratings. We accept challenging assignments and drive projects from the planning stages, through implementation, and into operations and support.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

Final compensation for this position will be determined by various factors such as the Federal Government contract labor categories and contract wage rates, relevant work experience, specific skills and competencies, geographic location, education, and certifications.

This position is filled through continuous recruitment and will remain open until a sufficient pool of applications has been received.

Hired applicants may be eligible for benefits, including but not limited to, medical, dental, vision, life insurance, Tricare supplement, short-term disability, long-term disability, 401(k) match, flexible spending accounts, health savings accounts, employee assistance program, learning and development benefit, paid time off, and holidays.

Odyssey Benefits