Program Manager Study Intake Research

AdventHealth; Orlando (FL); Remote; USD 75,000 - 115,000; Full time

Job summary

An established industry player is seeking a Program Manager for Study Intake to lead clinical trials and research studies. This role involves collaborating with various stakeholders to ensure successful project initiation and compliance with regulatory standards. You will be part of a vibrant community dedicated to delivering exceptional healthcare, where your contributions will help shape the future of clinical research. Join a team that values your unique experiences and fosters professional growth while making a significant impact on patient care. If you are passionate about research and thrive in a dynamic environment, this opportunity is perfect for you.

Benefits

Benefits from Day One

Paid Days Off from Day One

Career Development

Whole Person Wellbeing Resources

Mental Health Resources and Support

Qualifications

• 5+ years in healthcare or research environment.
• Experience in clinical trial operations from execution through completion.

Responsibilities

• Manage execution of clinical trials and research studies.
• Collaborate with teams to assess new protocol feasibility.

Skills

Clinical Trial Operations

Regulatory Compliance

Research Project Management

Feasibility Assessment

Communication Skills

Education

Bachelor’s degree in Medical, Scientific, Business, Administration, Healthcare

MS in Medical, Life Sciences, Healthcare, Business or Administration

Job description

Program Manager - Study Intake – AdventHealth Orlando

All the benefits and perks you need for you and your family:

- Benefits from Day One

- Paid Days Off from Day One

- Career Development

- Whole Person Wellbeing Resources

- Mental Health Resources and Support

Our promise to you:

Joining AdventHealth is about being part of something bigger. It’s about belonging to a community that believes in the wholeness of each person, and serves to uplift others in body, mind and spirit. AdventHealth is a place where you can thrive professionally, and grow spiritually, by Extending the Healing Ministry of Christ. Where you will be valued for who you are and the unique experiences you bring to our purpose-minded team. All while understanding that together we are even better.

Schedule: Full Time, Remote

Shift : Days

Location: 601 EAST ROLLINS STREET, Orlando, 32803

The community you’ll be caring for: 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

The role you’ll contribute:

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.

The value you’ll bring to the team:

• 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.
• In collaboration with central offices, department administration, and other stakeholders, recommends, develops, and updates institutional policies and procedures to ensure compliance with all applicable regulations
• Participates in internal and/or external training programs, staying current and compliant on knowledge and skills applicable to assigned duties

The expertise and experiences you’ll need to succeed:

• Minimum qualifications
• 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
• If RN, must be License in state of Florida

• Preferred qualifications:
  • MS in Medical, Life Sciences, Healthcare, Business or Administration
  • Pharmaceutical, CRO or research unit leadership experience in a health-care or research site setting
  • Five (5) years of operational assessment and review of research opportunities.

o Certification as Clinical Research Associate (CCRA) through the Society of Clinical Research Associates (SOCRA) or Clinical Research Coordinator (CCRP) through the Association of Clinical Research Professionals (ACRP)