Clinical Research Coordinator

Prolerity Clinical Research•Metairie, LA

13d

About The Position

The Clinical Research Coordinator (CRC) oversees and manages the daily operational activities of assigned clinical research studies. Working closely with investigators, clinical staff, study participants, sponsors, and CROs, the CRC ensures research activities comply with study protocols, regulatory requirements, and ethical standards. The role owns study coordination, documentation, data management, and sponsor communication, supporting compliant trial execution from study start-up through close-out.

Requirements

Bachelor’s degree in a related field.
Minimum of two years of clinical research or clinical trial management experience.
Prior experience performing blood draws and handling biological specimens is required.
Strong leadership and communication skills.
Exceptional organizational and multitasking abilities.
High attention to detail and commitment to regulatory compliance.
Ability to work independently and collaboratively in a multidisciplinary environment.
Strong time management and operational efficiency skills.
Proficiency with office equipment and study-specific systems.
Ability to maintain strict confidentiality.

Nice To Haves

Medical certification or licensure, such as MS, LPN, or RN.

Responsibilities

Organize, plan, and coordinate assigned clinical trials from initiation through close-out.
Support study start-up activities, including feasibility, regulatory submissions, and site activation.
Attend investigator meetings, site initiation visits, and other study-related meetings.
Manage visit schedules and coordinate study activities across clinical teams.
Collaborate with recruitment teams to support participant screening and enrollment.
Conduct informed consent discussions, ensure participants understand study requirements, and document consent.
Ensure protocol and regulatory requirements are met throughout enrollment.
Monitor and assess study subjects according to protocol requirements.
Identify, document, and report adverse events in collaboration with the Principal Investigator and clinical staff.
Escalate safety concerns and protocol issues to the PI, sponsor, and IRB as required.
Maintain accurate and complete source documentation, case report forms, regulatory files, and study records.
Enter study data into EDC and other required systems and manage study databases.
Complete, verify, and resolve case report forms and sponsor or monitor queries in a timely manner.
Report protocol deviations to the PI, sponsor, and IRB as required.
Manage investigational product accountability records and documentation.
Collect, process, package, and ship study specimens according to protocol requirements.
Perform phlebotomy and handle biological specimens according to study protocols and safety guidelines when trained and authorized.
Ensure study activities comply with SOPs, GCP, and regulatory requirements.
Support quality assurance activities and audit readiness.
Provide assistance and mentorship to fellow coordinators as needed.
Maintain strict confidentiality of participant and study information.
Serve as the primary point of contact for sponsor and CRO communications.
Participate in occasional outreach or community events related to clinical trials.
Ensure timely and accurate communication of study updates and issues.
Perform additional duties as needed to support study requirements, operational needs, and organizational priorities.