Clinical Research Manager

The Clinical Research Manager oversees on‑site research operations, including supervising the conduct of clinical trials, recruiting new research studies and investigators, and ensuring regulatory responsibilities are met. This RION study is part of the MIRROR portfolio. It is a Phase 1b, open‑label, dose‑escalation study designed to evaluate the safety and tolerability of a single dose of PEP administered via intratendinous injection under ultrasound guidance by the Principal Investigator. Salary: $105,000 – $120,000. Salaries are determined based on external market data, internal equity, and the candidate’s related knowledge, skills, and abilities for the position. Qualifications Bachelor’s degree or relevant experimental background required 3–5 years experience in clinical research preferred 3–5 years non‑profit, research, or healthcare experience desired 1–3 years experience in staff or project management Demonstrated competence in oral and written communication Must be organized, attentive to detail, and possess a positive, friendly, and professional demeanor Must be flexible with changing priorities and able to communicate diplomatically and professionally Ability to exercise independent judgment in a fast‑paced, high‑pressure environment with strict deadlines and manage multiple projects Computer skills including at least intermediate level experience with Excel and Microsoft Office Experience writing and submitting IRB protocols preferred Experience with FDA‑regulated clinical trials required Management Responsibilities Oversee study‑related conduct ensuring staff perform tasks within scope of the project Plan and facilitate individual and team meetings Ensure all staff comply with Foundation and site policies, procedures, and SOPs Proactively prepare and conduct site evaluation and study initiation visits Provide regulatory oversight of clinical trials Cognizant of and promote networking opportunities with sponsors, subjects, and physicians Responsibilities Promote safety and confidentiality of research subjects at all times Meet or exceed sponsor and Geneva enrollment, study execution, and monitoring expectations on assigned studies Conduct study review on a recurring basis Demonstrate competency and accuracy in conducting research activities, including participant screening, recruitment, and completion of source documentation and case report forms Report and document adverse events (AEs) and serious adverse events (SAEs) per sponsor requirements Ensure maintenance of complete and accurate drug accountability at all times Demonstrate proficiency in performing basic study‑related procedures (e.g., vital signs, ECG, phlebotomy) as required Cognizant of and adhere to FDA and OSHA regulations and GCP guidelines Utilize appropriate platforms to facilitate participant communications and study visit scheduling Assist in the preparation of all required technical progress reports Maintain and update files of all applicable regulatory documentation for IRB (including protocols, approvals, amendments, modifications, etc.) and internal study documents (logs, manual of procedures, etc.) and communications with sponsors or other federal or regulatory offices Attend, facilitate, document, and communicate Safety Review Committee (SRC) meetings in accordance with roles and responsibilities outlined in the SRC charter Serve as site subject matter expert (SME) for regulatory affairs actions, compliance with federal and military‑specific regulations, good documentation practices (GDP), and general good research practices (GRP) Advise study team members on good research practices and answer ad‑hoc study conduct‑related questions that arise throughout the research lifecycle Oversee, prepare, and track regulatory lifecycle actions submitted to the Institutional Review Board (IRB) spanning from initial submissions to continuing review submissions, protocol amendments/modifications, reportable events, and closure reports Perform data quality checks in alignment with the data management plan #J-18808-Ljbffr The Geneva Foundation