Clinical Research Coordinator I

Patient Recruitment and Consent

• Identifies, recruits, and obtains informed consent from potential study participants in compliance with study protocols and ethical guidelines.
• 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.

Study Protocol Design and Oversight

• Interpret study protocols, assessing feasibility, and modify procedures to align with the objectives of clinical trials.

Study Visits

• Coordinate and conduct study visits, including patient interviews, sample collection, and other protocol-driven procedures.

Data Collection and Entry

• Accurately collect, record, and manage study data.
• Ensure timely data entry into the Clinical Trial Management System (CTMS).

Data Analysis and Reporting

• Interpret data to make recommendations on the direction of the research and adjust study parameters based on preliminary findings.
• Query Resolution: Work with the study team to resolve data queries and discrepancies in accordance with Good Clinical Practice (GCP) guidelines.

Compliance and Regulatory Decisions

• Interpret and apply regulatory requirements, ensuring trials comply with legal, ethical, and institutional standards, and address issues without minimal supervision by the Clinical Program Manager.
• Regulatory Management: 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.

Regulatory Responsibilities

• 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.

Other Responsibilities

• May be required to provide oversight and guidance to Assistant Clinical Research Coordinators and other support personnel.
• Remote and On-Site Study Leadership: 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.

Qualifications

• A BA/BS in biological sciences, public health, or a related field OR five (5) plus years of clinical research 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.

Preferred

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

Physical Requirements, Workplace Hazards and Conditions, and PPE and Chemical Requirements

The physical requirements, workplace hazards and conditions, and PPE and chemical requirements described here are representative of those that a candidate must meet to perform the essential functions of this job. Reasonable accommodation may be provided to enable individuals with disabilities to perform essential job functions.