Job Description

Description

Director Research Institute AdventHealth Tampa

Location Address: 3100 East Fletcher Avenue Tampa, Florida 33613

Top Reasons to Work at AdventHealth Tampa

• AdventHealth Tampa Pepin Heart Institute, known across the country for its advances in cardiovascular disease prevention, diagnosis, treatment and research.
• Surgical Pioneers – the first in Tampa with the latest robotics in spine surgery
• Building a brand new, six story surgical and patient care tower which will ensure state of the art medical and surgical car for generations to come
• Awarded the Get With The Guidelines – Stroke GOLD Quality Achievement Award from the American Heart Association/American Stroke Association and have been recognized as a recipient of their Target: Stroke Honor Roll for our expertise in stroke care. We have also received certification by The Joint Commission in collaboration with the American Stroke Association as a Primary Stroke Center.

Work Hours/Shift:

FT Days

PRINCIPAL DUTIES AND JOB RESPONSIBILITIES:

• Achieve regional / national recognition for Pepin Heart Hospital / FHT.

• Promote Research Institute to physicians and the community.

• Supervision of clinical research operations and oversight of protocols from implementation to completion.

• Serve as point of contact for Investigators, research staff, and auditors to answer questions, resolve problems, advise, and prepare/negotiate agreements.

• Medical supervision of patient care with Principal / Sub-Investigator physicians.

• Manage patient follow-up visits  with Principal / Sub-Investigator physicians.

• Review laboratory / EKG / study results performed for study patient management.

• Work with research staff to ensure continuous research education is provided to all departments and staff.

• Assist with educational requirements for the IRB, Investigators and related staff.

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• Develop and implement orientation programs for new research staff as well as promote ongoing training, continuing education, and professional development.

• Create a positive image by demonstrating professional, courteous manner in all encounters.

• Make decisions and act in the overall interest of the customer and the hospital.

• Monitor progress of all clinical research projects/trials on an ongoing basis relative to established timelines and key milestones. Ensure that delays are identified and communicated to PIs and research staff. Participate in and facilitate efforts to implement appropriate interventions across functional groups in order to meet timelines.

• Identify operational problems, issues, obstacles, and barriers across all projects based on input from research staff, PIs, and sponsors; communicate patterns and trends; and participate in and support efforts to develop and implement process/system improvements.Modify, as needed, hospital and department system to support services management.

• Develop positive working relations with other functionally related units of the hospital.

• Acknowledge patients, staff and physicians promptly.

• Maintain patient, staff and hospital confidentiality at all times.

• Provide verbal and written communications, which are clear, concise and complete.

• Responsible for integrating the mission, visions, and values of health system into the service line.

• Hire and supervise research and IRB staff.

• Network and collaborate with administration, physicians, sponsors and coordinators for the recruitment of studies.

• Collaborate with other research sites for the advancement of clinical trial research and development.

• Encourage and support front line decision-making.

• Promote, support and reward activities that foster cooperation and teamwork.

• Maintain high employee satisfaction

• Develop Institute’s budget plan and assure compliance.

• Assess resource requirement needs for each clinical trial.

• Assess and maintain equity of workload for the research staff on an ongoing basis.

• Develop, approve and negotiate study specific contracts and budgets and assure compliance.

• Develop and negotiate outside service agreements and requests for discounted research services.

• Achieve timely reconciliation of visits completed / sponsor invoicing

1. Sponsor invoicing of outstanding visits not paid.

2. Sponsor invoicing of IRB / Admin startup fees.

• Achieve timely, compliant billing and hospital account reconciliation.

  1. ID research patients to initiate bill hold / charge reconciliation.

  2. Sponsor invoicing of research-only procedures performed for research.

  3. Collaborate to assure best practices are maintained in billing compliance for clinical research.

  4. Monitoring of insurance payments received / denials / appeals on research-related hospital accounts.

  5. Sponsor invoicing of denied insurance payments.

• Prepare and report financial statements reflecting:

1. Rolling Profit / Loss statement

2. Contract Value

3. A/R on accrual vs. cash basis

4. A/P for physician / 3^rd party services provided.

• Responsible for assuring all patient informed consents are compliant with FDA and OHRP GCP/ICH guidelines.

• Ensure all research activities are in compliance with JCAHO; FDA; GCP/ICH Guidelines.

• Maintain all study regulatory documents and records according to FDA and OHRP GCP/ICH guidelines.

• Ensures policies and procedures for the Research Institute and IRB are updated to reflect current regulations.

• Oversee regulatory functions and assure IRB and FDA/GCP/ICH regulation compliance.

• Prepare annual research report based on clinical trial performance metrics of the Research Institute.

• Maintain a list of all protocols and related activities and communicate to administration.

• Review new protocols for patient safety, cost effectiveness, scientific merit and feasibility.

• Receive and review all research activities in the hospital.  Triage projects to the appropriate person for approval. Notify administration of any potential issues or conflicts regarding research activities.

• Promote and maintain, together with the Medical Director, collaborative alliances with community physicians and organizations who participate or have the desire and qualifications to participate in the Pepin Heart Hospital and Research Institute research program.

• Develop/update the Institute’s business plans for program’s expansion and joint ventures.

• Procure new, innovative research studies and initiate/collaborate in the development, with medical staff, of Institute’s initiated research.

• Maintain membership and regular attendance in appropriate professional associations.  Attend related conferences, workshops and seminars to stay current with new developments and knowledge.

• Demonstrate effective team building and leadership skills.

Qualifications

KNOWLEDGE AND SKILLS REQUIRED:

• Expert knowledge of all applicable federal regulations governing the use of human subjects.  Strong knowledge and experience with IND and IDE Trials is required.

• Individual must be able to work collaboratively with a diverse population of individuals, building and maintaining professional relationships with investigators, staff, hospital administration, and study sponsors.

• Exhibit strong organizational, communicative, diplomatic and empathic skills.

   

EDUCATION AND EXPERIENCE REQUIRED:

 

•         Master’s degree, health-related field

•         Ten years’ clinical management experience

•         Minimum five years’ experience in a research regulatory environment involving human subject’s protection program.

EDUCATION AND EXPERIENCE PREFERRED:

 

•         Doctoral degree in related field and Business degree

•         Ten years’ primary/specialty direct patient care experience

 

LICENSURE, CERTIFICATION OR REGISTRATION PREFERRED:

 

• ARNP/PA-C

• ACRP or SoCRA certification in clinical research

This facility is an equal opportunity employer and complies with federal, state and local anti-discrimination laws, regulations and ordinances.