The role You will own the day-to-day conduct of assigned studies from start-up through close-out: recruiting and retaining participants, keeping source documentation and regulatory files inspection-ready, entering clean data in EDC, and serving as the primary link between the Principal Investigator, the Sponsor/CRO, and the IRB. This is a high-ownership role for a coordinator who is organized, protocol-driven, and comfortable with enrollment targets. What you will do Study conduct and participants Screen, recruit, consent, and follow study participants; build trust with patients and families and ensure protocol adherence and retention. Meet enrollment timelines set by Research Management across all assigned studies. Schedule and perform study visits; coordinate specimen collection, processing, and shipment per protocol (IATA-compliant). Data and documentation Maintain accurate, complete, and timely source documents and case report forms; enter and resolve data in EDC (Medidata Rave, Veeva, Oracle, or similar). Manage the regulatory binder/eTMF, adverse event and deviation reporting, and study correspondence. Regulatory and IRB Prepare and submit new protocols, amendments, and continuing reviews to IRB (WIRB) and local IRBs; verify that all approved documents and required corrections are received and filed in the correct format. Contribute to protocol development and to initial and ongoing GCP training for site staff. What you bring Required 2+ years of hands-on clinical research coordination experience in Phase I, II, and/or III trials. Working experience with EDC systems and IRB submissions (new protocols, amendments, continuing reviews). Current ICH-GCP certification and IATA dangerous goods/shipping certification (or ability to obtain within 30 days). Strong command of source documentation, regulatory files, and adverse event reporting. Excellent organization, follow-through, and written/verbal communication with investigators, sponsors, and patients. Legal authorization to work in the United States. Preferred Bilingual English/Spanish (strongly preferred — our patient population is largely Hispanic). How to apply Submit your resume and a brief cover note describing the trials you have coordinated (phases, therapeutic areas, EDC systems used) through Indeed. Qualified candidates will be contacted within one week. Galenus Group, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, national origin, age, disability, or veteran status.

Job Type:

Full-time Work Location:

In person