Monitor Sponsor clinical studies at sites within the U.S. Responsible for the management of assigned clinical study sites. Ensures the regulatory and scientific integrity of studies. Evaluates, monitors, and documents all study information. Maintains excellent relationships, and contact with site personnel and uses good judgment based on GCPs, ICH Guidelines.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Responsibilities include, but are not limited to:
- As a member of the clinical project team, provides CRA oversight for Soligenix managed clinical trials. This includes but is not limited to planning, organizing, and communicating with and managing sites to allow them to meet study objectives for study protocols.
- Participates in clinical team meetings; leads discussion on assigned protocol(s).
- Prepares a variety of documents including protocols, CRFs, informed consent forms, operations manuals, and other documentation required for the conduct of a clinical trial.
- Identifies potential investigators. Conducts and/or reviews pre-study site visits to assure adequacy of site, investigators, and research staff in accordance with SOPs and relevant regulations/guidelines. Recommends acceptable sites to study and management teams.
- Manages day-to-day clinical operations of assigned protocol(s), including management of vendors (e.g., CRO, central lab, sites, SMOs) and coordination of team member activities.
- Initiates the development of a template site budget for management review and approval, and negotiates budget with sites.
- Participates in conducting investigator meetings, including advance preparation, presentations, problem resolution, and follow-up.
- Performs initiation, interim and close-out site visits in accordance with SOPs when applicable.
- Takes a lead role, under the supervision of a Clinical Manager, to develop comprehensive subject recruitment strategies and monitors enrollment to assure compliance with clinical milestones.
- Identifies, analyzes, and reports serious compliance issues, and develops action plans for approval by management. May conduct monitoring or accompanied oversight visits to resolve difficult study conduct issues.
- Ensures continual availability, at each site, of clinical and non-clinical supplies necessary to meet study requirements.
- Reviews data tables, listings, and study reports for assigned protocol(s).
- Reviews data listings, manages processes, and facilitates data review from internal and external sources. Tracks all decisions and items that develop from internal meetings. Coordinates and ensures that all paper and/or electronic study related documents are appropriately filed for submission and inspection purposes.
- Anticipates study conduct issues and assists in developing contingency plans prior to study initiation and throughout the life of the trial.
- Conducts oversight visits to CROs throughout the life of the trial and in preparation for inspection.
- Performs other duties as assigned, including continuing to successfully perform functional responsibilities of CRAs.
EDUCATIONAL REQUIREMENTS (degree, license, certification):
- Bachelors degree in a health science field or nursing degree.
YEARS OF EXPERIENCE:
- Minimum of 3 years of experience in the pharmaceutical industry and 3-6 years of clinical trial and monitoring experience.
- Experience in working on at least 2 multicenter, Phase 2 clinical studies and 1 Phase 3 clinical study.
- Experience working in the clinical settings of oncology and/or gastroenterology.
PHYSICAL REQUIREMENTS / WORKING CONDITIONS of POSITION:
OTHER SKILLS AND ABILITIES:
- Requires comprehensive knowledge of the pharmaceutical clinical development process and applicable regulations and guidelines.
- Thorough knowledge of study SOPs
- Good working knowledge of medical terminology, physiology, and pharmacology in multiple therapeutic areas.
- Solid understanding of the roles and responsibilities of all functional areas in the extended project team.
- Knowledge of GCP/ICH and applicable regulatory requirements.
- Strong communication, organizational and planning skills.
- Strong computer skills with demonstrated experience in working with Microsoft Office programs (Word, Excel, PowerPoint, and Outlook).
- Good understanding of CRA-related software, e.g., eCRF, IVRS.
- Strong problem solving and analytical skills.
- Ability to travel up to 50% of the time.