Clinical Research Coordinator

American Clinical Research Services Opco LLC•Dallas, TX

11d•Hybrid

About The Position

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.

Requirements

Minimum high school diploma required.
3 + years Clinical Research Coordinator Experience Required
Strong Psychiatric experience required
Familiarity with Good Clinical Practice (GCP) and regulatory guidelines (FDA, ICH).
Knowledge of clinical trial management software and electronic data capture systems.
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.

Nice To Haves

Bachelor's degree in Life Sciences, Nursing, or a related field.
Clinical rating experience preferred.
Certification as a Clinical Research Coordinator (e.g., ACRP, SOCRA) is a plus.

Responsibilities

Performs study subject screening and recruitment.
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.
Collects, labels, stores, and ships specimens collected from subjects in connection with a clinical trial.
Enters patient and research data in designated systems.
Maintains patient charts and resolves research queries.
Monitors study activities to ensure compliance with study protocols and applicable regulations.
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.
Assesses eligibility of potential subjects through screening interviews, medical record reviews, and discussions with healthcare professionals.
Oversees subject enrollment to ensure informed consent is properly obtained and documented.
Records adverse events and side effect data and confers with Investigators regarding reporting to oversight agencies.
Prepares for or participates in quality assurance audits.
Creates source documents 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, data management, and potential subject risks.
Instructs research staff in scientific and procedural aspects of studies.
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, and/or attends conferences and seminars.
Orders drugs or devices necessary for study completion.
Documents findings and events in the Company’s research CTMS platform and other designated platforms.
Performs occasional travel to Company sites, Principal Meetings, and/or Company meetings.
Performs other duties as assigned.