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MPF Federal, LLC · 1 month ago

Clinical Research Coordinator 1

San Diego, California, United States

Full-time

Onsite

New Grad, Entry Level

$68K/yr - $71K/yr

MPF Federal, LLC is seeking a Clinical Research Coordinator I to support the Naval Health Research Center's Operational Infectious Diseases Directorate. The role involves coordinating and managing clinical research studies, including patient recruitment, data collection, and ensuring compliance with regulatory standards.

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Responsibilities

Identifies, recruits, 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 clinical trials: Handle complex logistics of trials, solve problems related to compliance or participant concerns, and make adjustments to protocols based on emerging situations during the study

Interprets study protocols, assesses feasibility, and modifies 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

Qualification

Clinical Trial ManagementRegulatory ComplianceData CollectionPatient RecruitmentQuality ControlProblem SolvingTeam Collaboration

Required