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Senior Clinical Research Coordinator
2 months ago
We are seeking a Senior Clinical Research Coordinator to support a health organization in San Diego, CA.
Successful Candidate will:
Coordinate with members of the organization to help ensure that clinical research and related activities are performed in accordance with federal regulations and sponsoring agency policies and procedures.
Develop 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.
Conduct study feasibility assessments as requested.
Collaborate to prepare IRB/HRPO and any other regulatory submission documents as required by the protocol.
Establish and organize study files, including but not limited to, regulatory binders, study specific source documentation and other materials.
Review and develop a familiarity with the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections.
Assists in communication of study requirements to all individuals involved in the study.
Collect documents needed to initiate the study and submit to the sponsor.
Develop and implement recruitment strategies in accordance with requirements and approvals.
Conduct the informed consent process including interactions with the IRB and discussions with research participants, including answering any questions related to the study.
Screen subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant's eligibility or exclusion.
Register each participant in the billing matrix to ensure billing of study procedures to the appropriate funding source.
Coordinate participant tests and procedures.
Collect data as required by the protocol. Assure timely completion of Case Report Forms.
Requirements Include:
Masters degree in a healthcare-related field is required.
2 plus years of senior research coordinator experience.
Ability to undergo a background investigation which requires U.S. Citizenship.
Project management skills.
Excellent communication skills, both verbal and written.
Must have documented experience of aiding at least one resident in the design and completion of a clinical research scholarly activity project.
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