Sub Investigator

We are seeking a dedicated and detail-oriented part-time Sub-Investigator to join our research division, the Florida Research Institute (FRI). The successful candidate will play a pivotal role in conducting clinical trials and research studies focused on gastroenterological diseases and treatments. This role involves close collaboration with the Principal Investigator (PI), Senior Director of Clinical Research and Development and research staff to ensure the integrity, compliance and successful execution of research protocols. The Sub-Investigator will assess physical health and administer treatments throughout the study aligned with scope of practice delegated responsibilities and oversee study conduct and assure study participant safety. He/she will also coordinate and manage care for participants enrolled in a clinical research trial and overseeing the execution of study protocols, delegating study related duties to site staff and ensuring site compliance with study protocols, study-specific laboratory procedures, standard operating procedures, standards of Good Clinical Practice (GCP), adhering to OSHA guidelines and other state and local regulations as applicable.

Under the direction of the Senior Director of Clinical Research and Development and Principal Investigator, responsibilities will include the following: identify and recruitment of participants, participate in study visits, communicate with families, participants, referring physicians and other health care providers, educating and guidance to participants and families to ensure compliance and retention of study participants, tracking and recording of adverse events, perform physical exams to ensure enrollment criteria and to track for any changes during study participation, diagnose and treat medical conditions such as allergic reactions and anaphylaxis during study drug administration, exacerbations of illness, formulate and evaluate treatment plans, manage common conditions such as allergic rhinitis, asthma and eczema, review home diaries and administer rescue medications based on clinical judgment.

Our Culture: Inspire hope. Build your legacy. Discover a rewarding, fulfilling, well-balanced career at Florida Digestive Health Specialist, LLP. With providers and locations across Florida, FDHS is one of the largest single-specialty, physician-owned GI practices in the state. FDHS was established in 2011 to provide comprehensive, high-quality gastroenterology services and foster advanced research for digestive health problems. With a growing team of nationally acclaimed care centers, providers, and staff, we continue to expand our reach to communities that need our care.

Job Details:

• Part-time (3 Days) Monday – Friday
• No Weekends
• No Holidays
• No On-Call

Essential duties:

• Ensure the safety of study participants, and maintain communication with patients, FRI team members and clinicians.
• Provide clinical and medical support and oversight for research clinical trials based on scope of practice; obtain complete study participant history, conduct physical exams, review medical charts, assess findings, prescribe medication, and perform designated procedures according to written protocols.
• Collaborate with clinical staff, researchers, outside vendors, and other staff to administer treatment and study protocols.
• Assess, grade, and document adverse events; apply triage and judgment to determine course of action.
• Oversee and, as needed, administer medications and treatments per study protocol and scope of practice.
• Comply with institutional policies, standard operating procedures, and guidelines; prepare and submit documentation as required by the study protocol and study sponsor; interpret complex protocols. Coordinate and collaborate with principal investigator to review study protocol.
• Assist recruitment team to identify, recruit, and enroll study participants, as well as maintain study participant records; determine study participant criteria.
• Support sponsor investigator research with investigational new drug/investigational device exemption applications.
• Communicate with FDHS partner when indicated
• Responsible for guidance of medical assistance team.
• Manage patient medical and scheduling issues when indicated.
• Other duties as assigned. Please note that the duties and responsibilities outlined in this job description are not exhaustive and may be subject to change at any time to meet the evolving needs of the company. In addition to the responsibilities listed above, employees may be required to perform additional tasks or duties as assigned by management.

QUALIFICATIONS AND REQUIREMENTS

• Medical degree with current medical licensure in the state of Florida is required
• Requires a thorough knowledge of the: Drug development process, Clinical trial management, study team management, Clinical monitoring, FDA regulations, ICH Good Clinical Practice, and Good Documentation Practice, HIPAA
• Current Basic CPR certification
• DEA license

OTHER SKILLS AND ABILITIES:

• Team player - Effective participant as a team member and team leader. Can demonstrate significant positive participation on successful teams.
• Professionalism and integrity - Able to adapt to a changing environment and demonstrates a “make it happen” attitude. Exhibits professionalism in negotiating sensitive issues. Exhibits professionalism in negotiating sensitive issues.
• Problem solving techniques
• Managing study team members to maintain clinic workflow and study organization
• Interpersonal interaction - Demonstrates excellent people skills and a positive attitude.
• Communication - Effective verbal communication and presentation skills. Ability to write clear, concise and convincing memos, letters and articles using original or innovative techniques or style.
• Ability to prioritize and to manage multiple tasks as necessary.
• Attention to detail - Produces high-quality, accurate work with minimal supervision
• Flexibility - Ability to adapt and be willing to assist with achieving Company goals in the area of responsibility and time.

WORKING CONDITIONS:

• May be required to work with, take specific precautions against, and/or be immunized against potentially hazardous agents.
• May be exposed to blood borne pathogens.

EEO Statement:

It is the policy of Florida Digestive Health Specialists to provide equal employment opportunities without regard to race, color, religion, sex, national origin, age, disability, marital status, veteran status, sexual orientation, genetic information or any other protected characteristic under applicable law.

­When you join FDHS, you become part of a premier team striving to deliver unparalleled, personalized care while treating patients like family. And at FDHS, our patients are at the heart of everything we do. Join our team at FDHS and make a difference in the lives of our patients and employees alike