Clinical Research Coordinator 1

MPF Federal•San Diego, CA

9d•Hybrid

About The Position

MPF Federal seeks a Clinical Research Coordinator I to support the Naval Health Research Center (NHRC). This role involves patient recruitment, study protocol oversight, conducting study visits, data management, and ensuring regulatory compliance. The coordinator will interpret study protocols, collect and manage data, resolve data queries, and make regulatory decisions with minimal supervision. They will also assist with IRB submissions, collaborate with investigators and sponsors, and prepare for monitoring visits. Additional responsibilities include potential oversight of support personnel and conducting research activities in varied environments, including remote sites which may involve travel. The role requires making real-time decisions regarding study operations and troubleshooting unexpected scenarios.

Requirements

A BA/BS in biological sciences, public health, or equivalent OR five (5) plus years of infectious disease Biosurveillance experience.
Familiarity with regulatory requirements for clinical trials, including IRB submissions and reporting processes.
Proficiency in Clinical Trial Management Systems (CTMS) and electronic IRB systems.
Strong organizational, communication, and problem-solving skills.
Ability to work both independently and collaboratively in a research setting.
US Citizenship and the ability to obtain and maintain a T3/Secret Clearance.

Nice To Haves

Certification in clinical research (such as CCRC or CCRP).
Experience with infectious disease studies or military health research.

Responsibilities

Identifies, and obtains informed consent from potential study participants in compliance with study protocols and ethical guidelines.
Help lead recruitment efforts, developing and refining strategies to meet enrollment targets.
Make independent decisions about how to target and select participants, and whether a potential participant meets eligibility criteria.
Manage and coordinate complex biosurveillance.
Interprets study protocols, assessing feasibility, and modifying procedures to align with the objectives of clinical trials.
Coordinates and conducts study visits, including patient interviews, sample collection, and other protocol-driven procedures.
Accurately collects, records, and manages study data.
Ensures timely data entry into the Clinical Trial Management System (CTMS).
Interprets data to make recommendations on the direction of the research and adjusts study parameters based on preliminary findings.
Works with the study team to resolve data queries and discrepancies in accordance with Good Clinical Practice (GCP) guidelines.
Interprets and applies regulatory requirements, ensuring trials comply with legal, ethical, and institutional standards, and addressing issues without minimal supervision by the Clinical Program Manager.
Assists with Institutional Review Board (IRB) submissions and protocol amendments.
Collaborate with principal investigators and sponsors and provide insights based on field experience.
Recommend changes to improve study feasibility and evaluate the implications of protocol adjustments on ongoing activities.
Ensures compliance with all regulatory requirements, including study registrations in the electronic IRB (eIRB) system.
Maintains accurate study documentation and ensures that study protocols are adhered to throughout the study lifecycle.
Ensure that the research team follows procedures.
Troubleshoot and resolve any deviations or challenges that may arise.
Develop and implement quality control procedures, identify areas for improvement, and resolve any issues that could impact the validity or integrity of the study outcomes.
Prepares for and participates in monitoring visits, audits, and inspections by regulatory agencies.
Prepares and submits initial and continuing IRB applications, study amendments, and adverse event reports in compliance with NHRC and sponsor requirements.
Ensures all study-related documents are appropriately filed and accessible for audits.
Manages study registrations and updates in the Clinical Trial Management System and eIRB system.
May be required to provide oversight and guidance to Assistant Clinical Research Coordinators and other support personnel.
Conduct research activities in varied environments, such as on naval ships or other remote sites, which may involve travel.
Coordinate logistics, including equipment and resource allocation, and serve as a research team representative on-site.
Make real-time decisions regarding study operations and troubleshoot unexpected scenarios to ensure study fidelity and safety.
Performs other duties as assigned.