Clinical Research Manager

About the PositionThe Clinical Research Manager oversees on-site research operations to include supervision of the conduct of clinical trials, recruitment of new research studies and investigators, and oversight of all regulatory responsibilities.About the ProjectThis RION study is within the MIRROR portfolio. This 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 several factors including external market data, internal equity, and the candidate’s related knowledge, skills, and abilities for the position.QUALIFICATIONSBachelors degree or experimental background required3-5 years experience in clinical research preferred3-5 years non-profit, research, or healthcare experience desired1-3 years experience in staff or project managementDemonstrate competence in oral and written communicationMust be organized, attentive to detail, and possess a positive, friendly and professional demeanorMust be flexible with changing priorities and able to communicate in a diplomatic and professional mannerAbility to exercise independent judgment in fast-paced, high-pressured environment with strict deadlines and to manage multiple projectsComputer skills including at least intermediate level experience with Excel and Microsoft Office SoftwareExperience writing and submitting IRB protocols preferredExperience with U.S. Food and Drug Administration (FDA) regulated clinical trials requiredMANAGEMENT RESPONSIBILITIESOversee study related conduct ensuring staff perform tasks within scope of projectPlan and facilitate individual and team meetingsEnsure all staff complies with Foundation and site policies, procedures and SOPsProactively prepare and conduct site evaluation and study initiation visitsProvide regulatory oversight of clinical trialsCognizant of and promotes networking opportunities with sponsors, subjects, and physiciansRESPONSIBILITIESPromote safety and confidentiality of research subjects at all timesMeet or exceed sponsor and Geneva enrollment, study execution, and monitoring expectations on assigned studiesConduct study review on a recurring basisDemonstrate competency and accuracy in conducting research activity, including participant screening and recruitment and completion of source documentation and Case Report FormsReport and document Adverse Events (AEs) and Serious Adverse Events (SAEs) per sponsor requirementsEnsure maintenance of complete and accurate drug accountability at all timesDemonstrate proficiency in performing basic study related procedures (e.g., Vital Signs, ECG, phlebotomy, etc.) as requiredCognizant of and adhere to Federal Drug Administration and Occupational Safety and Health Administration regulations and Good Clinical Practices guidelinesUtilize appropriate platforms to facilitate participant communications and study visit schedulingAssist in the preparation of all required technical progress reportsMaintain and update files of all applicable regulatory documentation for IRB (including protocols, approvals, amendments, modifications, etc.) as well as internal study documents (logs, manual of procedures, etc.), and any communications with the sponsor or any other Federal or regulatory office (including prior approvals, change in scope, etc.)Attend, facilitate, document, and communicate Safety Review Committee (SRC) meetings in accordance with roles and responsibilities outlined in Safety Review Committee CharterServe 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 lifecycleOversee, 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, etc.Perform data quality checks in alignment with the data management plan #J-18808-Ljbffr