Study Intake Program Manager

adventhealth; Orlando (FL); Presencial; USD 66.000 - 123.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

N/A

Descripción de la vacante

AdventHealth in Orlando, FL is seeking an experienced professional to oversee clinical trial operations from execution to completion. You will ensure compliance with ICH-GCP and federal regulations, coordinate feasibility analyses, and support sponsor interactions.

The role requires a Bachelor’s degree and 3+ years in clinical trial operations; RN preferred. You will collaborate with investigators and business development to advance high-quality trials while maintaining regulatory excellence.

Formación

• Excellent interpersonal and communication abilities across all levels.
• Self-motivated, detail-oriented with strong organizational skills.
• Experience with clinical trial operations from execution through completion.
• Deep knowledge of study-startup processes and feasibility assessments.
• Familiarity with local, state, and federal regulations governing trials.
• Proficiency with Microsoft Office and internet-based tools.

Responsabilidades

• Ensure research activities comply with applicable regulations.
• Develop and update institutional policies and procedures.
• Participate in training to stay current on ICH-GCP and regulations.
• Communicate effectively with investigators, leadership, staff, and collaborators.
• Review feasibility of projects and update business development leads.
• Identify and pursue quality and revenue-generating trials with BD teams.
• Initiate operational review and obtain approvals for projects.
• Route feasibility assessments with sponsor and site investigators.

Conocimientos

Interpersonal skills

Communication

Detail-oriented

Organizational skills

Clinical trials operations

MS Office

Multitasking

Regulatory knowledge

Educación

Bachelor's degree

Herramientas

MS Office

Descripción del empleo

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.

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

• Benefits from Day One: Medical, Dental, Vision Insurance, Life Insurance, Disability Insurance
• Paid Time Off from Day One
• 403-B Retirement Plan
• 4 Weeks 100% Paid Parental Leave
• Career Development
• Whole Person Well-being Resources
• Mental Health Resources and Support
• Pet Benefits

Schedule:

Full time

Shift:

Day (United States of America)

Address:

601 E ROLLINS ST

City:

ORLANDO

State:

Florida

Postal Code:

32803

Job Description:

Ensures all research activity is conducted in full compliance with regulations governing research activity.Recommends, develops, and updates institutional policies and procedures to ensure compliance with applicable regulations. Participates in internal and external training programs to stay current and compliant on knowledge and skills applicable to assigned duties. Performs other duties as assigned. Maintains current knowledge of ICH Good Clinical Practices and all local, state, and federal regulations governing human subjects' research. Communicates effectively and timely with investigators, scientists, leadership, staff, and external research collaborators. Reviews existing research projects for ongoing feasibility in collaboration with operations teams and provides updates to business development leads. Identifies and pursues quality, revenue-generating clinical trials in collaboration with business development teams. Initiates the operational review process for research projects and elicits input from key stakeholders. Reviews and routes feasibility assessments of proposed research projects, including sponsor collaboration, engagement with site investigators, and exploratory discussions with operations teams.Ensures operational approval of research projects and submits to protocol review and monitoring system (PRMS) for scientific study approval.

Knowledge, Skills, and Abilities:

• Excellent interpersonal skills and the ability to effectively communicate with all levels of personnel– executives, management, staff, Physician Investigators and supporting teams [Required]
• Self-motivated and detail-orientated, with good organizational, follow-up, computer and analytical skills [Required]
• Experience with clinical trial operations from execution through completion [Required]
• Deep expertise in all aspects of study-startup including synopsis reviews and feasibility assessments, study-related deep dives, pre- and site-selection visits [Required]
• Demonstrated experience aggregating study and sponsor and/or funder-related information for comprehensive scientific, operational and administrative review in a timely manner [Required]
• Knowledge of all local (institutional), state, GCP and federal regulations governing human subjects’ clinical trials [Required]
• Ability to conduct oneself professionally, maintaining confidence, confidentiality, integrity and objectivity [Required]
• Proficient in Microsoft Office (Outlook, Word, Excel, PowerPoint), knowledge and skill to use the Internet, and other relevant computer programs [Required]
• Flexible and comfortable working in a fast-paced environment with multiple stakeholders [Required]
• 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]

Education:

• Bachelor's[Required]

Field of Study:

• in Medical, Scientific, Business, Administration, Healthcare, or related field

Work Experience:

• 3+ clinical trial operations from execution through completion [Required] OR
• 5+ healthcare or research environment [Required]

Additional Information:

• N/A

Licenses and Certifications:

• Registered Nurse (RN) [Preferred]

Physical Requirements:

(Please click the link below to view work requirements)

Physical Requirements - https://tinyurl.com/23km2677

Pay Range:

$66,268.80 - $123,281.60

Background Screening Requirement (Florida Law)

Certain positions are subject to Florida Level 2 background screening, including fingerprinting, as required by state law.

Florida Care Provider Background Screening Clearinghouse

Applicants may review general information about Florida’s background screening requirements at the https://info.flclearinghouse.com/

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