Clinical Research Coordinator 1

MPF Federal•San Diego, CA

2d•$68,000 - $73,000•Hybrid

About The Position

MPF Federal seeks a Clinical Research Coordinator I to support the Naval Health Research Center (NHRC). This role involves a wide range of responsibilities related to clinical trial management, from patient recruitment and data collection to regulatory compliance and on-site leadership in diverse environments. The position requires a strong understanding of research protocols, regulatory requirements, and the ability to work independently and collaboratively.

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.
Helps lead recruitment efforts, developing and refining strategies to meet enrollment targets.
Makes independent decisions about how to target and select participants, and whether a potential participant meets eligibility criteria.
Manages and coordinates 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.
Collaborates with principal investigators and sponsors and provide insights based on field experience.
Recommends changes to improve study feasibility and evaluates 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.
Ensures that the research team follows procedures.
Troubleshoots and resolves any deviations or challenges that may arise.
Develops and implements quality control procedures, identifies areas for improvement, and resolves 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.
Conducts research activities in varied environments, such as on naval ships or other remote sites, which may involve travel.
Coordinates logistics, including equipment and resource allocation, and serves as a research team representative on-site.
Makes real-time decisions regarding study operations and troubleshoots unexpected scenarios to ensure study fidelity and safety.
Performs other duties as assigned.