Clinical Study Coordinator

Psi CRO; Tulsa (OK); On-site; USD 60,000 - 90,000; Full time

Job summary

Milestone One seeks a Site/Study Coordinator to support clinical trial activities at a medical institution. The role involves coordinating with the Sponsor or CRO, assisting with feasibility and recruitment, and ensuring protocol adherence across visits and data tasks.

Responsibilities include data entry into EDC systems, regulatory document preparation, site training, and collaboration with cross-functional teams to maintain study quality and compliance.

Qualifications

• Requires 2+ years coordinating clinical research studies involving human subjects.
• GCP certification required. IATA, CPR, Phlebotomy can be required or desirable.
• Certification in Clinical Research (ACRP or SOCRA) preferred or obtainable within 1 year.

Responsibilities

• Serve as primary liaison between Milestone One, Sponsor/CRO, and the medical institution.
• Assist feasibility assessment and provide timely responses to feasibility questions.
• Identify and evaluate patient recruitment and site eligibility for study inclusion.

Education

GCP

IATA

CPR

Phlebotomy Certification

ACRP/SOCRA Certification

Job description

Milestone One is a Site Enabling Services organization with global headquarters in Zug, Switzerland. We understand what clinical study sites need and our overall mission is to support sites in stronger study delivery.

Job Description

The Site/Study Coordinator supports a medical institution in clinical trial-related activities. Protocol-specific tasks will be determined by the Principal Investigator, considering all local and federal laws and regulations and upon review of competencies observed and documented by Milestone One. Tasks may include activities associated with thefeasibility of new/potential clinical studies, conducting research-related visits as outlined in the respective protocol, assisting thesite with logistics of scheduling research visits and testing per the schedule of events in the protocol, collaboration with ancillary departments involved in theresearch visit to assist in a smooth patient flow at research visits., general study conduct tasks, assistance with data entry into study related EDC systems, contact with CRO or sponsor representatives to schedule and conduct monitoring visits as well as resolve study specific issues at the medical institution. In addition, mentoring staff and administrative tasks as assigned by the Milestone One Manager.

In this job you will:

• Acts as a constant line of communication between Milestone One, the Sponsor or CRO, and the medical institution.
• Facilitates the evaluation of proposed studies and ensures responses to feasibility questions are provided in due time.
• Actively participates in patient recruitment/identification and evaluation for study inclusion by confirming eligibility according to the Inclusion and exclusion criteria.
• Assists with plan development for new recruitment / retention tools, source documentation and other site tools to enhance quality and time management of research staff.
• Assists the local research team in obtaining informed consent before study entry or any study-related procedures or tests being performed.
• Assist with obtaining the required assessments at each visit per the protocol and notify the investigator of any critical values that need immediate attention orwould prohibit or delay study treatment.
• Assist with obtaining local and central laboratory testing, processing, and shipping per site SOP and study-specific lab manual.
• Assistin scheduling and preparation for all types of sponsors or CRO representative visits at the medical institution.
• Trackpatient recruitment and enrollment and actively supports the medical site team to ensure enrollment targets are met at the site level. Provides regular updates to the staff and investigators regarding study amendments.
• Ensureaccurate and timely data entry into study-specific EDC systems, resolves data queries, and assists in reporting and following up on adverse events and protocol deviations according to guidelines and investigator instructions.
• Supportproper handling, accountability, and reconciliation of all investigational products and clinical supplies. If applicable, always maintain the study blinding. Protocol and sponsor/CRO guidance will be followed if a study participant requires unblinding.
• Assistsite staff with maintaining appropriate temperature monitoring for study products and supplies.
• Supportthe contract and budget negotiationsand oversees Investigator/Site Payments.
• Ensure that all staff participating in a clinical trial complete all necessary study-specific and general training before their involvement in the trial. Retraining will be completed for changes to theprotocol before site implementation.
• Be responsible for ensuring the investigator reviews and signs study documents appropriately and within a reasonable period. Guidance should be provided to educate the site research team on requirements for conducting clinical trials, date format, etc.
• Actively participatein maintaining study documents at the medical institution in preparation for on-site study visits/audits or regulatory agency inspections.
• Assistwith preparing and submitting regulatory documents and correspondence to regulatory authorities and institutional review boards (IRBs).
• May be involved in the on-site training of additional staff as part of the SEO or other education programs.
• Assistwith identifying areas that need improvement for specific sites and assists with developing tools to assist with improvements.
• Maintainall licensure and certifications applicable to the role of SEO site/Study coordinator II.
• SEO SCis responsible for only performing assigned tasks within their training and licensure if applicable. SEO SCshould immediately consult the assigned Milestone One manager for tasks that do not fall within their scope.

Qualifications

Education

Relevant education and at least two years of experience coordinating clinical research studies involving human subjects OR, if allowed by local regulations, on-the-job training with at least two years of experience coordinating clinical research studies involving human subjects.

Certifications

• Current Good Clinical Practice (GCP)
• International Air Transport Association (IATA)
• Current Basic Cardiopulmonary Resuscitation (CPR)
• Phlebotomy certification unless part of active professional licensure (RN or LPN)
• Preferred Certification in Clinical Research by ACRP or SOCRA or another approved Clinical Research Organization. May be obtained within (1) year of employment or status change if not currently certified.

Additional Information

Location: Tulsa, OK

If you feel it is time to make your skills and knowledge visible within a developing company with true focus on its people, then Milestone One is the right choice for you!