Clinical Research Coordinator

Summary: The Clinical Research Coordinator (CRC) manages and coordinates clinical research studies, ensuring they are conducted efficiently, ethically, and in compliance with regulatory requirements. The role involves working with principal investigators, research staff, and study participants to oversee all aspects of trials, including recruitment, data management, regulatory compliance, and monitoring participant progress.

Duties and Responsibilities: The Clinical Research Coordinator:

• Performs study subject.
• Screens and recruits’ subjects.
• Doses and administers study drugs and/or implements study methodologies.
• Accounts for study drugs.
• Communicates with subjects and medical group providers, including the Principal Investigator and any Sub-Investigators.
• Accounts for study drugs.
• Communicates with subjects and medical group providers, including the Principal Investigator and any Sub-Investigators.
• Collects, labels, stores, and ships specimens collected from subjects in connection with a clinical research trial.
• Enters patient and research data in systems designated by the company.
• Maintains patient charts and resolves research queries.
• Monitors study activities to ensure compliance with study protocols and with applicable federal, state, and local regulatory and site requirements.
• Maintains required records of study activity including case report forms, drug dispensation records, and regulatory forms.
• Tracks enrollment status of subjects and documents dropout information, such as dropout causes and subject contact efforts and communicates this information as directed.
• Assess eligibility of potential subjects through methods such as screening interviews, reviews of medical records, and discussions with physicians and other health care professionals.
• Oversees subject enrollment to ensure that informed consent is properly obtained and documented.
• Records adverse events and side effect data and confers with Investigators regarding the reporting of events to oversight agencies.
• Prepares for or participates in quality assurance audits conducted by study sponsors, federal agencies, or designated review groups.
• Creates source documents as assigned, such as regarding protocols, memos, patient participation.
• Prepares study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports.
• Reviews proposed study protocols to evaluate factors such as sample collection processes, data management plans, and potential subject risks.
• Instructs research staff in scientific and procedural aspects of studies including standards of care, informed consent procedures, or documentation procedures.
• Collaborates with Investigators and Company Management to prepare presentations or reports of clinical study procedures, results, and conclusions.
• Communicates with laboratories or investigators regarding laboratory findings.
• Reviews scientific literature, participates in continuing education activities, and/or attends conferences and seminars to maintain knowledge of clinical research.
• Orders drugs or devices necessary for study completion.
• Documents findings and events in the Company’s research CTMS platform and in other binders and platforms as directed.
• Occasional travel to Company sites, Principal Meetings, and/or Company meetings.
• Performs other duties as assigned.

Requirements:

• Minimum high school diploma required.
• Bachelor's degree in Life Sciences, Nursing, or a related field preferred
• Knowledge of clinical trial management software and electronic data capture systems required
• 2+ Years of previous CRC experience required
• Phlebotomy preferred
• Bilingual English/ Spanish preferred
• Familiarity with Good Clinical Practice (GCP) and regulatory guidelines (FDA, ICH) required
• Certification as a Clinical Research Coordinator (e.g., ACRP, SOCRA) is a plus but not required
• Enthusiasm for clinical research and a desire to learn required

Competency Requirements:

• Strong organizational and time management skills.
• Excellent attention to detail and ability to maintain accurate records.
• Effective communication skills, both written and verbal.
• Ability to work independently and collaboratively in a team environment.
• Proactive problem-solving skills and adaptability in a dynamic setting.