Clinical Sub Investigator
Job Description
Job Description
Prescreen Coordinator
The ARNP / DNP / Sub Investigator promotes Good Clinical Practice in the conduct of clinical investigations by ensuring adherence to protocol requirements, protecting the rights and welfare of study subjects, assuring the integrity of data generated at the site and directing the conduct of the clinical investigation according to federal and state regulations and guidance documents.
Primary Responsibilities :
- Provide investigator qualifications and agreements as required for study participation
- Maintain current, up-to-date curriculum vitae
- Maintain current licensure and continuing education
- Assume responsibility for the conduct of the clinical investigation
- Maintaining documentation of all aspects of the clinical investigation
- Ensure protocol compliance
- Ensure initial and ongoing review and oversight by a duly constituted IRB
- Provide adequate facilities to conduct the clinical trial
- Manage the medical care of study participants (subjects)
- Ensure validity of data reported to sponsor
- Ensure documentation of study-related procedures, processes, and events
- Ensure proper use, storage, and return or disposal of investigational agents
- Maintain professional and technical knowledge
- Reading, understanding and adhering to organizational Standard Operating Procedures
- Assisting in establishing and enforcing departmental standards
- Contributes to team effort by :
- Working with internal staff to resolve issues by :
- Exploring new opportunities to add value to organization and departmental processes
- Helping others to achieve results
- Performing other duties as assigned
- Learn and support the mission and goals of Bioclinica Research’s program
- Maintains Technical and Industry Knowledge by Attending and participating in applicable company-sponsored training
Knowledge, Skills, and Abilities :
- Broad knowledge of general medicine
- Strong analytical and problem-solving skills
- Excellent organizational skills, detail oriented, efficient, and able to multi-task and prioritize effectively.
- Excellent interpersonal skills.
- Strong written and verbal communication skills Bilingual skills preferred.
Qualifications :
- Licensed ARNP or DNP in the state of FL
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