Program Manager Study Intake Research Institute Orlando
Location Address: 601 E. Rollins St., Orlando, FL 32801
Top Reasons to work at AdventHealth Orlando
Located on a lush tropical campus, our flagship hospital, 1,368-bed AdventHealth Orlando
serves as the major tertiary facility for much of the Southeast, the Caribbean and South America
AdventHealth Orlando houses one of the largest Emergency Departments and largest cardiac catheterization labs in the country
We are already one of the busiest hospitals in the nation, providing service excellence to more than 32,000 inpatients and 125,000 outpatients each year
Full Time, Days
You Will Be Responsible For:
In collaboration with business development teams, pursues quality, revenue-generating trials for AdventHealth
Responsible for reviewing and routing feasibility assessments of proposed research projects; activities include sponsor collaboration, engagement with site investigators, and exploratory discussion with operations teams
Initiates and oversees the scientific operational administrative review (SOAR) process of all incoming projects and eliciting feedback from key stakeholders
Provides assistance with regulatory processes as necessary to ensure smooth flow of study projects within the assigned departments
Communicates appropriately and effectively with AdventHealth investigators, scientists, leadership (AHRI and Institute) and staff as well as external research collaborators
Working closely with Operations teams, reviews existing research projects for ongoing feasibility and provides updates to business development leads for the purposes of elevating trial-matching for AdventHealth
Maintains current knowledge of ICH Good Clinical Practices for human subjects' research and all local, state, and federal regulations governing the conduct of human subject research and ensures that all research activity is conducted in full compliance with regulations
Collaborates with other AdventHealth Research departments, including but not limited to the Office of Sponsored Programs, Office of Research Integrity and the Institutional Review Board, to ensure federal, state, local, and institutional regulatory compliance Qualifications
What You Will Need:
Bachelor's degree in Medical, Scientific, Business, Administration, Healthcare, or related field
Five (5) years' experience in a healthcare or research environment OR
Three (3) years' experience in clinical trial operations from execution through completion
MS in Medical, Life Sciences, Healthcare, Business or Administration (preferred)
Pharmaceutical, CRO or research unit leadership experience in a health-care or research site setting (preferred)
Five (5) years of operational assessment and review of research opportunities (preferred)
Excellent interpersonal skills and the ability to effectively communicate with all levels of personnel- executives, management, staff, Physician Investigators and supporting teams
Experience with clinical trial operations from execution through completion
Deep expertise in all aspects of study-startup including synopsis reviews and feasibility assessments, study-related deep dives, pre- and site-selection visits
Demonstrated experience aggregating study and sponsor and/or funder-related information for comprehensive scientific, operational and administrative review in a timely manner
Knowledge of all local (institutional), state, GCP and federal regulations governing human subjects' clinical trials
Proficient in Microsoft Office (Outlook, Word, Excel, PowerPoint), knowledge and skill to use the Internet, and other relevant computer programs
Flexible and comfortable working in a fast-paced environment with multiple stakeholders
Expertise in supplier relationship management tools for the purposes of tracking leads (preferred)
Knowledge of clinical trial landscape, industry trends, pathways and expertise in disease pathophysiology (preferred)
The Program Manager - Study Intake (Manager) is responsible for the execution of business and administrative processes required for the assessment, review and ultimately the initiation of clinical trials and research studies for a minimum of three therapeutic areas (i.e. Cardiovascular, Cancer, Neuroscience, Oncology, Digestive Health) within the AdventHealth Research Institute.
In this role, the Manager works with business development, investigators, AdventHealth administration, operational leadership, hospital staff, sponsoring agencies, and others to effectively assess new protocol feasibility and efficiently execute the initial phase of bringing clinical trials to AdventHealth up to and including the AdventHealth Scientific Operational and Administrative Review (SOAR) process.
The Manager collaborates with business development and physician scientists to identify quality clinical trials and research projects that meet the needs of the institutes and service lines they serve. Maintains accurate and timely record of study start-up status for each opportunity. May attend national meetings to learn about new trials and site activation practices that add value to the organization. Actively participates in outstanding customer service and accepts responsibility in maintaining relationships that are equally respectful to all.
This facility is an equal opportunity employer and complies with federal, state and local anti-discrimination laws, regulations and ordinances.
AdventHealth Greater Orlando (formerly Florida Hospital) is one of the largest faith-based health care providers in the United States. For 150 years, we have carried on a tradition of providing whole-person care that not only addresses patients' physical ailments, but also supports their emotional and spiritual well-being. We demonstrate the same level of compassion and care for our employees as well, doing all that we can to help them realize their full potential – both personally and professionally.