ESSENTIAL DUTIES AND RESPONSIBILITIES Include the following. Others may be assigned.
1. Analyze information for appropriate clinical trial agreements to identify research tasks
2. Analyze information for appropriate clinical trial agreements to identify research costs to assure that costs are included in budget negotiations
3. Work with facility resources to determine pricing, coding and determination whether services are Standard of Care or Research Specific
4. Screens patients for Inclusion/Exclusion Criteria and communicates with the physicians regarding the patient’s participation
5. Reads the protocol and develops source documents according to the protocol flow chart
6. Performs any lab procedures required for the clinical trial(s)
7. Able to take at least 5 trials, based on the complexity
8. Follows Informed Consent Document guidelines for consenting subjects
9. Accountable for Investigational Product (IP). Assures proper storage of IP according to the protocol. Instructs the patients on the how to take the IP and to bring all IP back to the site at each visit. Allows the patient to verbalize understanding of the instructions. Patients are instructed to bring back even the empty containers of IP. Maintain Study Specific Drug accountability Logs (as applicable)
10. Maintaining all study specific Logs
Qualifications
EDUCATION / EXPERIENCE Include minimum education, technical training, and/or experience required to perform the job.
Bachelor’s degree in science, Healthcare or a related field required; or education recognized by the State of Florida as qualification for Registered Nurse licensure Certified Clinical Research Professional (CCRP) or Registered Nurse licensed in the state of Florida At least five years of experience in research Knowledge of federal and state laws governing research preferred Knowledge of medical terminology Knowledge and understanding of both CPT and ICD-10 codes preferred.Experience with medical record documentation review for accuracy, and compliance with all laws, rules, policies and procedures preferred.Must possess strong problem solving, analytical skills and process management skills. Must possess strong planning, organizational and project management skills, interpersonal and oral/written communication skills. Requires attention to detail and the ability to manage multiple priorities. Self-motivated and possess excellent communication skills with strong attention to detailProficiency in a windows environment with a working knowledge of Word, Outlook, PowerPoint, Excel, and the Internet is required#LI-WB1
Description
The Reseach Manager is responsible for the management of Tenet’s Clinical Research Compliance Program, policy development and management of the department. The role may be the leader or my report to the Director. The Research Manager is responsible for the oversight of research coordinators, auditors, assistants. General activities associated with the position include: review and processing of new studies, maintenance of study database, other compliance auditing and monitoring initiatives as required, and assisting with relevant compliance training and education to hospital staff. Models appropriate behavior as exemplified in the Tenet's Standard of Conduct.
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