Full 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:
022; Excellent interpersonal skills and the ability to effectively communicate with all levels of personnel- executives, management, staff, Physician Investigators and supporting teams [Required]
022; Self-motivated and detail-orientated, with good organizational, follow-up, computer and analytical skills [Required]
022; Experience with clinical trial operations from execution through completion [Required]
022; Deep expertise in all aspects of study-startup including synopsis reviews and feasibility assessments, study-related deep dives, pre- and site-selection visits [Required]
022; Demonstrated experience aggregating study and sponsor and/or funder-related information for comprehensive scientific, operational and administrative review in a timely manner [Required]
022; Knowledge of all local (institutional), state, GCP and federal regulations governing human subjects' clinical trials [Required]
022; Ability to conduct oneself professionally, maintaining confidence, confidentiality, integrity and objectivity [Required]
022; Proficient in Microsoft Office (Outlook, Word, Excel, PowerPoint), knowledge and skill to use the Internet, and other relevant computer programs [Required]
022; Flexible and comfortable working in a fast-paced environment with multiple stakeholders [Required]
022; Expertise in supplier relationship management tools for the purposes of tracking leads [Preferred]
022; Knowledge of clinical trial landscape, industry trends, pathways and expertise in disease pathophysiology [Preferred]
Education:
022; Bachelor's [Required]
Field of Study:
022; in Medical, Scientific, Business, Administration, Healthcare, or related field
Work Experience:
022; 3+ clinical trial operations from execution through completion [Required] OR
022; 5+ healthcare or research environment [Required]
Additional Information:
022; N/A
Licenses and Certifications:
022; Registered Nurse (RN) [Preferred]
Physical Requirements: (Please click the link below to view work requirements)
Physical Requirements - https://tinyurl.com/23km2677
Relocation Bonus Eligibility:
All regions, except Academic Strategy:
Eligibility requires relocation from more than 50 miles away. Former AdventHealth employees are eligible after 12 months of separation.
Example:
Up to $10,000 Relocation Bonus for eligible applicants*
* Eligibility requires relocation from more than 50 miles away. Former AdventHealth employees are eligible after 12 months of separation.
Academic Strategy: Eligibility requires relocation from more than 50 miles away.
Example:
Up to $10,000 Relocation Bonus for eligible applicants*
* Eligibility requires relocation from more than 50 miles away.
Sign-On Bonus Eligibility:
022; CFD, Corporate Services, EFD, RMR, SWR: Former AdventHealth employees are eligible after 12 months of separation. One year of applicable experience is required for candidates to receive the bonus.
022; WFD Acute: Former AdventHealth employees are eligible after 12 months of separation. One year of applicable experience is required for candidates to receive the bonus.
022; WFD Non-Acute, MAR, PHD, SER, SWR: Former AdventHealth employees are eligible after 12 months of separation.
022; GLR: Former AdventHealth employees are eligible after 12 months of separation.
022; Experience requirements vary by position. Some positions require 1 year of relevant experience and others require 2 years. Some positions do not require experience.
022; Academic Strategy does not have restrictions; all external candidates are eligible for a sign-on bonus. No additional information is needed in the job posting.
Pay Range:
$66,268.80 - $123,281.60
