Clinical Study Coordinator

Milestone One•Tulsa, OK

12h

About The Position

The Site/Study Coordinator supports a medical institution with clinical-trial-related activities. Protocol-specific tasks are determined by the Principal Investigator, taking into account applicable laws and regulations and the coordinator’s documented competencies. Responsibilities may include study feasibility assessment, research visits, visit scheduling and logistics, coordination with ancillary departments, general study conduct, data entry, sponsor or CRO monitoring visits, issue resolution, staff mentoring, and 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. The role supports participant recruitment and retention, informed consent, protocol-required assessments and testing, study-product accountability, accurate study documentation and data, regulatory submissions, staff training, and preparation for monitoring visits, audits, and inspections. The coordinator must perform only tasks within their training and licensure and consult the assigned Milestone One manager about tasks outside their scope.

Requirements

Relevant education and at least two years of experience coordinating clinical research studies involving human subjects; alternatively, where local regulations allow, 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 it is included in active professional licensure as an RN or LPN.
Maintain applicable licensure and certifications.
Perform assigned tasks only within the scope of training and licensure, if applicable.

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

Act as a consistent line of communication between Milestone One, the sponsor or CRO, and the medical institution.
Facilitate evaluation of proposed studies and provide timely responses to feasibility questions.
Participate in patient recruitment, identification, and assessment for study inclusion according to inclusion and exclusion criteria.
Help develop recruitment and retention tools, source documentation, and other site tools to improve quality and research-team time management.
Assist the local research team in obtaining informed consent before study entry or study-related procedures or tests.
Help obtain protocol-required assessments at each visit and notify the investigator of critical values requiring immediate attention or that could prohibit or delay treatment.
Assist with local and central laboratory testing, processing, and shipping according to site SOPs and study-specific lab manuals.
Schedule and prepare for sponsor or CRO representative visits at the medical institution.
Track recruitment and enrollment and support the medical site team in meeting site enrollment targets.
Provide staff and investigators with updates about study amendments.
Enter data accurately and on time into study-specific EDC systems, resolve data queries, and assist with adverse-event and protocol-deviation reporting and follow-up according to guidelines and investigator instructions.
Support handling, accountability, and reconciliation of investigational products and clinical supplies; maintain blinding when applicable and follow protocol and sponsor/CRO guidance for unblinding.
Assist site staff with temperature monitoring for study products and supplies.
Support contract and budget negotiations and oversee investigator/site payments.
Ensure staff complete required study-specific and general training before trial involvement and complete retraining for protocol changes before site implementation.
Ensure the investigator reviews and signs study documents appropriately and within a reasonable period.
Educate the site research team about clinical-trial requirements, including date formats.
Help maintain study documents in preparation for site visits, audits, or regulatory inspections.
Assist with preparing and submitting regulatory documents and correspondence to regulatory authorities and IRBs.
May train additional staff onsite as part of SEO or other education programs.
Help identify site improvement areas and develop tools to support improvements.
Maintain licensure and certifications applicable to the SEO Site/Study Coordinator II role.
Perform only assigned tasks within the coordinator’s training and licensure, and promptly consult the assigned Milestone One manager about tasks outside that scope.
Mentor staff and perform administrative tasks as assigned by the Milestone One Manager.