About the Position
The 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 Project
This 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.
QUALIFICATIONS
- Bachelors degree or 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
- Demonstrate 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 in a diplomatic and professional manner
- Ability to exercise independent judgment in fast-paced, high-pressured environment with strict deadlines and to manage multiple projects
- Computer skills including at least intermediate level experience with Excel and Microsoft Office Software
- Experience writing and submitting IRB protocols preferred
- Experience with U.S. Food and Drug Administration (FDA) regulated clinical trials required
MANAGEMENT RESPONSIBILITIES
- Oversee study related conduct ensuring staff perform tasks within scope of project
- Plan and facilitate individual and team meetings
- Ensure all staff complies 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 promotes 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 activity, including participant screening and 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, etc.) as required
- Cognizant of and adhere to Federal Drug Administration and Occupational Safety and Health Administration regulations and Good Clinical Practices 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.) 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 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, etc.
- Perform data quality checks in alignment with the data management plan
