Clinical Study Coordinator

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 the assessment of the feasibility of new or potential clinical studies, conducting research-related visits as outlined in the respective protocol, assisting the site with logistics of scheduling research visits and testing per the schedule of events in the protocol, collaboration with ancillary departments involved in the research 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, and resolve study-specific issues at the medical institution. In addition, mentoring staff and administrative tasks are assigned by the Milestone One Manager. In this job you will: Act as a constant line of communication between Milestone One, the Sponsor or CRO, and the medical institution. Facilitate the evaluation of proposed studies and ensure responses to feasibility questions are provided in due time. Actively participate in patient recruitment, identification, and evaluation for study inclusion by confirming eligibility according to the inclusion and exclusion criteria. Assist with plan development for new recruitment and retention tools, source documentation and other site tools to enhance quality and time management of research staff. Assist the local research team in obtaining informed consent before study entry or any study-related procedures or tests being performed. Obtain the required assessments at each visit per the protocol and notify the investigator of any critical values that need immediate attention or could prohibit or delay study treatment. Obtain local and central laboratory testing, processing, and shipping per site SOP and study-specific lab manual. Schedule and prepare for all types of sponsors or CRO representative visits at the medical institution. Track patient recruitment and enrollment and actively support the medical site team to ensure enrollment targets are met at the site level. Provide regular updates to the staff and investigators regarding study amendments. Ensure accurate and timely data entry into study-specific EDC systems, resolve data queries, and assist in reporting and following up on adverse events and protocol deviations according to guidelines and investigator instructions. Support proper handling, accountability, and reconciliation of all investigational products and clinical supplies. If applicable, always maintain the study blinding. Follow protocol and sponsor/CRO guidance for unblinding when required. Assist site staff with maintaining appropriate temperature monitoring for study products and supplies. Support contract and budget negotiations and oversee 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 the protocol before site implementation. Ensure that the investigator reviews and signs study documents appropriately and within a reasonable period. Provide guidance to educate the site research team on requirements for conducting clinical trials, date format, etc. Actively participate in maintaining study documents at the medical institution in preparation for on-site study visits, audits, or regulatory agency inspections. Assist with 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. Identify areas that need improvement for specific sites and develop tools to assist with improvements. Maintain all licensure and certifications applicable to the role of SEO Site/Study Coordinator II. Perform only assigned tasks within their training and licensure; 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 one year of employment or status change if not currently certified. Additional Information Location: Tulsa, OK #J-18808-Ljbffr