Clin Res Project Coordinator I

Universities of WisconsinMadison, WI

About The Position

Join a collaborative and mission-driven research team within the Department of Obstetrics and Gynecology as a Clinical Research Project Coordinator supporting innovative, non-cancer related women’s health research. This role provides the opportunity to contribute to impactful clinical trials and research initiatives across Maternal Fetal Medicine, General Obstetrics and Gynecology, Reproductive Endocrinology and Infertility, and Urogynecology. The Clinical Research Project Coordinator serves as the central coordinator for administrative clinical trial activities, including study activation, maintenance, and closure processes. This position partners closely with Principal Investigators, research teams, clinical research coordinators, study sponsors, and external collaborators to ensure successful administration of research protocols and achievement of study goals within established timelines. Responsibilities may include coordination of local site trial management as well as support for external participating sites. The ideal candidate is highly organized, collaborative, and passionate about advancing women’s health research through operational excellence and strong relationship management. This is an exciting opportunity to join a growing research program dedicated to improving patient outcomes and advancing clinical innovation. This position has been identified as a position of trust with access to vulnerable populations. The selected candidate will be required to pass an initial caregiver check to be eligible for employment under the Wisconsin Caregiver Law and every four years.

Requirements

  • 2 years employment experience in Clinical Research Coordination and Clinical Trials is required by the start date of the position.

Nice To Haves

  • Bachelor’s Degree preferred; focus in life sciences/healthcare or related field preferred

Responsibilities

  • Designs and develops a system of databases for research data in a format suitable for analysis
  • Serves as the primary liaison between the HSC and MFM/Meriter and ASOG clinical staff. Create site specific workflows that are within clinic and protocol limits to fully integrate clinical research as part of clinical care.
  • Assist with training of staff
  • Serves as a main point of contact for clinical research participants, providing information regarding research procedures, expectations, and informational inquiries. Ensures participants follow the research protocol and alerts Principal Investigator of issues
  • Serves as point of contact for external institutions participating in clinical research studies. Ensures data is entered accurately by study team(s), which may include monitoring study records for completeness and accuracy
  • Coordinates and assists with development of investigator-initiated study protocols and associated documents, both during initial development and when changes are required. May contribute to the development of protocol Case Report Forms
  • Schedules, coordinates, and prepares for sponsor site visits, ensuring that all study records are available, complete, and accurate for sponsor review
  • Collaborates with investigators, research staff, study sponsors, and other collaborators to rapidly move clinical trial research protocols through the activation process. May assist with coordination of and communication related to new clinical trial opportunities
  • Interfaces with investigators, research staff, sponsors, and collaborators to maintain clinical trials, including reviewing, evaluating, and implementing new protocols, protocol amendments, ensuring timelines and milestones are met; assists with, or is responsible for proper study close-out procedures and communication to ensure proper trial management.
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