This position is responsible for Clinical Research program, including compliance with the achievement of the activities outlined in Tenet's Compliance Program. Activities associated with research and compliance include but are not limited to; adherence to hospital research policies, hospital research review and approval process, ensuring hospital compliance with Medicare's clinical trials policies, education of staff regarding research policies, etc. 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.
Maintain complete oversight of the day-to-day operations of the following areas of Clinical Research Services
Including regulatory affairs, patient recruitment and data management, quality control and quality assurance, budgeting and financial systems, informatics, staffing, office management, education, and new policy and procedure development.
Be the primary resource to physicians, research staff, and patients regarding the clinical trials performed and the investigational drugs used.
Assure compliance with and for all Federal regulations and laws governing the conduct of clinical trials in human subjects, following the International Committee on Harmonizationâ��s â��Good Clinical Practicesâ�� Guidelines.
Be accountable for the finances for the Research Program, compiling and disseminating reports, managing the accounts payables and receivables, and on a quarterly basis, distributing the funds received and paying the bills per outlined contracts/agreements within your facility.
REQUIRED POSITION QUALIFICATIONS:
Bachelor's Degree in Business Administration, Healthcare Administration, Clinical or related disciplines required with research focus preferred; or education recognized by the State of Florida as qualification for Registered Nurse licensure.
Three to five years of experience in clinical research to include healthcare compliance, research auditing, monitoring standards, or related experience.
Knowledge of federal and state laws governing research preferred.
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.
Ability to work without close supervision or guidance and to exercise independent judgment.
General PC skills.
Certification through a clinical trials professional organization (SoCRA or ACRP). Certification should be maintained. If certification not current or potential hire does not have at date of hire, a plan will be put into place to test within one year of year of hire.
3+ years managerial experience
Prior experience in fiscal management and contracts negotiation
Job: Managers and Directors
Primary Location: Palm Beach Gardens, Florida
Facility: Palm Beach Gardens Medical Center
Job Type: Full-time
Shift Type: Days
Employment practices will not be influenced or affected by an applicantâ��s or employeeâ��s race, color, religion, sex (including pregnancy), national origin, age, disability, genetic information, sexual orientation, gender identity or expression, veteran status or any other legally protected status. Tenet will make reasonable accommodations for qualified individuals with disabilities unless doing so would result in an undue hardship.