Clinical Study Coordinator

PSI CRO•Tulsa, OK

About The Position

The Site/Study Coordinator supports a medical institution with clinical trial-related activities. Protocol-specific duties are determined by the Principal Investigator, taking into account applicable laws and regulations and competencies observed and documented by Milestone One. The role may involve study feasibility, protocol-required research visits, visit scheduling and logistics, coordination with ancillary departments, general study conduct, data entry in electronic data capture (EDC) systems, and coordination with sponsor or CRO representatives. The coordinator may also mentor staff and perform administrative tasks assigned by the Milestone One Manager. The coordinator serves as a communication link among Milestone One, sponsors or CROs, and the medical institution. Responsibilities include supporting feasibility assessments, participant recruitment and eligibility evaluation, informed consent, protocol assessments, laboratory activities, study visit preparation, enrollment tracking, data quality, investigational product and supply accountability, staff training, study documentation, regulatory submissions, and site improvement efforts. The coordinator must work within assigned training and licensure and consult the assigned Milestone One manager about tasks outside that scope.

Requirements

Relevant education and at least two years of experience coordinating clinical research studies involving human subjects, or, where local regulations permit, on-the-job training and at least two years of such experience.
Current Good Clinical Practice (GCP) certification.
International Air Transport Association (IATA) certification.
Current Basic Cardiopulmonary Resuscitation (CPR) certification.
Phlebotomy certification unless covered by active professional licensure as an RN or LPN.
Maintains applicable licensure and certifications and performs duties within the scope of training and licensure.

Nice To Haves

Certification in clinical research by ACRP, SOCRA, or another approved Clinical Research Organization; may be obtained within one year of employment or status change if not currently certified.

Responsibilities

Acts as a communication link between Milestone One, the sponsor or CRO, and the medical institution.
Facilitates evaluation of proposed studies and ensures feasibility questions are answered in a timely manner.
Participates in patient recruitment and identification and evaluates potential participants against inclusion and exclusion criteria.
Assists with developing recruitment and retention tools, source documentation, and other site tools to improve research quality and time management.
Assists the local research team in obtaining informed consent before study entry or study-related procedures or tests.
Assists with obtaining protocol-required assessments and notifies the investigator of critical values requiring immediate attention or that could prohibit or delay treatment.
Assists with local and central laboratory testing, processing, and shipping according to site SOPs and study-specific laboratory manuals.
Schedules and prepares for sponsor or CRO representative visits at the medical institution.
Tracks recruitment and enrollment, supports site enrollment targets, and updates staff and investigators regarding study amendments.
Enters study data accurately and promptly into study-specific EDC systems, resolves data queries, and assists with adverse event and protocol deviation reporting and follow-up.
Supports proper handling, accountability, and reconciliation of investigational products and clinical supplies, maintaining study blinding when applicable and following guidance for unblinding.
Assists site staff with temperature monitoring for study products and supplies.
Supports contract and budget negotiations and oversees investigator/site payments.
Ensures trial staff complete required study-specific and general training before participating, and completes retraining when protocol changes are implemented.
Ensures the investigator reviews and signs study documents appropriately and in a reasonable period, and educates the research team on clinical trial documentation requirements.
Maintains study documents at the medical institution in preparation for site visits, audits, and regulatory inspections.
Assists with preparing and submitting regulatory documents and correspondence to regulatory authorities and IRBs.
May provide on-site training to additional staff through SEO or other education programs.
Identifies site improvement needs and helps develop tools to address them.
Maintains role-related licensure and certifications.
Performs only assigned tasks within the scope of training and licensure and consults the assigned Milestone One manager about tasks outside that scope.
Mentors staff and performs administrative tasks as assigned by the Milestone One Manager.