Description
YOU ARE REQUIRED TO SUBMIT A RESUME WITH YOUR APPLICATION! PRMS Program Coordinator – Research Administration - Orlando Location Address: 800 N. Magnolia Ave., 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
Work Hours/Shift: You Will Be Responsible For: The Research PRMS Program Coordinator is responsible for coordinating, managing, and monitoring the day to day activities of the Protocol Review and Monitoring System (PRMS). This requires managing and facilitating various multi-disciplinary research studies through the PRMS simultaneously supporting multiple research departments across different therapeutic areas within the organization. Serves as a liaison between the Physician Investigators, Clinical Ops teams, Business Development, and Research Services, communicating appropriately and effectively with co-workers, customers and supervisors including physicians and leaders at all levels. Maintains awareness of study status and any potential delay, situation or concern that may affect the review, approval and/or implementation of the study. Actively participates in outstanding customer service and accepts responsibility in maintaining relationships that are equally respectful to all. Qualifications
What You Will Need: EDUCATION AND EXPERIENCE REQUIRED: - Bachelor’s degree in Healthcare, Biological Science, Nursing, Health Administration, Communication, or a related field and 2 years of experience working in a healthcare, clinical research or scientific setting; OR
- Associate Degree and at least four (4) years applicable work experience (working in a clinical research, healthcare or scientific setting); OR
- Equivalent work consisting of at least six (6) years of experience working in a healthcare, clinical research or scientific setting, an institutional review board office, research administration, or regulatory affairs in a pharmaceutical and/or medical device company; AND
- Previous experience in leading the implementation of a large, company-wide or system-wide project, such as new processes to implement, software application, policies and procedures, preparation for a government agency audit, etc.
EDUCATION AND EXPERIENCE PREFERRED: -
- Bachelor’s degree in Healthcare, Biological Science, Nursing, Health Administration, Communication, or a related field; AND
- Three or more years of work experience in Research Administration office in a management, project management or project coordination and implementation role.
LICENSURE, CERTIFICATION OR REGISTRATION PREFERRED: -
- Certification through any professional research organization such as the Society of Clinical Research Associates (SOCRA), Association of Clinical Research Professionals (ACRP), Society of Research Administrators International (SRA), or Public Responsibility in Medicine & Research (PRIM&R)
KNOWLEDGE AND SKILLS REQUIRED: - Knowledge of healthcare and/or research regulatory affairs, and ability apply healthcare and/or research regulations including preparing for healthcare audits by accrediting organizations and/or federal agencies.
- Awareness of and ability to interpret U.S. Code of Federal Regulations (CFR) related to the conduct of research including The Common Rule, Food and Drug Administration (FDA) regulations governing research including investigational drugs, devices, and biologics, and the International Conference on Harmonization/Good Clinical Practice (ICH/GCP) guidelines, the National Institutes of Health (NIH) including the Cancer Center Support Grant (CCSG) requirements, the Public Health Service (PHS) regulations for maintaining objectivity in research related to financial conflicts of interest, and PHS regulations related to research misconduct, and Federal regulations related to ClinicalTrials.gov registration and reporting.
- Ability to run committee meetings, conduct oneself professionally, maintaining confidence, confidentiality, integrity, alignment with strategies, and objectivity.
- Effective inter-personal skills and customer service focus is required.
- Effective oral and written communication skills, with the ability to articulate complex information in understandable terms to all levels of staff.
- Working knowledge of medical terminology.
- Strong time management and organizational skills in order to successfully manage multiple tasks simultaneously under aggressive regulatory and/or internal deadlines.
- Ability to work independently while maintaining attention to detail with guidance from Lead PRMS Program Coordinator and Director, with minimal supervision, and as part of a team.
- Demonstrated competency in computer skills, particularly Microsoft Office Outlook, Teams, Word, Excel, PowerPoint, Adobe, and SharePoint.
- Emotional intelligence, including self-awareness, in order to manage implicit biases
- Ability to maintain strict confidentiality of employees, other research team members, patients, research subjects, and institution AdventHealth information, especially related to patient protected health information and disclosed financial information and interests.
KNOWLEDGE AND SKILLS PREFERRED: -
- Knowledge in theoretical and practical aspects of project management and use of project management systems and change management ideologies.
- Familiarity with SmartSheet project management software
- Previous experience in clinical trials operations or research regulatory, knowledge of clinical trials regulatory requirements, experience working with an IRB, or working in a PRMS Coordinator role at a National Cancer Institute designated cancer center.
- Proficient in AHRI research applications including Florence eRegulatory application, IRBNet IRB application, Clinical Conductor Clinical Trials Management System (CTMS), and other research specific applications implemented within AHRI.
- Expertise in AdventHealth Research Institute (AHRI) Institutional Review Board (IRB) policies, procedures, and processes.
Job Summary: - Coordinates and facilitates PRMS meetings and attends all AHRI committee meetings that are a part of the PRMS for assigned departments, including Stage 1 Review, Protocol Review Committee (PRC), Protocol Monitoring Committee (PMC), and Data Safety Committee.
- Prepare and distribute correspondence related to PRMS committee reviews (PRC, PMC, and Data Safety Committees), including PRMS action letters and approvals, ensuring the effective dissemination of PRMS communications to all stakeholders to facilitate compliance with the PRMS process.
- Prepares for PRC (Protocol Monitoring Committee) meetings, compiles agendas, schedules meetings (secures space if needed), verifies submitted protocols meet requirements for placement on committee agendas by reviewing protocols prior to assignment and PRC Submission Forms for completeness and accuracy, prepares slides/presentation to assist investigators in presenting protocol to PRC, collect reviewer’s forms and log reviewer scores, composes official minutes.
- Prepares for and facilitates PMC meetings for the review of accrual including, meeting regularly with the PMC Chair and Co-Chair, scheduling, preparation of agenda, running enrollment reports, preparing accrual information including diversity, keep minutes, prepare and send committee communication, track meeting data, ensure charter and SOP are followed.
- Continuously reviews the PRMS for process gaps and makes recommendations for improvements.
- Meets weekly with PRC Chair, Co-Chair and leadership to plan upcoming full committee meetings, finalize agenda, approve assigned reviewers, present protocols for expedited review as needed, communicate and/or train on new applicable guidelines, regulations, policies, and/or institutional procedures.
- Serves as point of contact for PRMS inquiries and acts as administrative PRMS representative to internal and external audiences regarding PRMS activities providing timely follow up on requests from IRB, sponsors, study teams, research leadership and administration in a courteous and professional manner.
- Responsible for reviewing data elements and metrics to facilitate efficient project management, and as required for reporting to various stakeholders including leadership, Research Oversight Committee, Institutional Review Board, Research Compliance, and in some cases, AdventHealth affiliates and/or federal agencies as appropriate.
- Tracks PRMS metrics including membership, attendance, service term expirations, votes, volume of reviews, types of reviews, and decisions, etc. Also composes membership invitation or re-invitation letters as appropriate.
- Assist with creating process flows and development of Standard Operating Procedures as required.
- Maintains audit readiness at all times, by keeping files current and organized for all PRMS committee documentation to facilitate prompt reporting. Provides support for internal and external auditing and monitoring needs, assisting auditors, and making requested documents available for review.
- Ensures PRMS documents for all closed studies are archived and maintained per the applicable regulatory retention period, sponsor requirements, State, IRB, and AHRI policies and procedures.
- Communicates with COI office to confirm if there are any COI Management Plans (MPs) related to each research protocol that should be communicated to the PRMS committees. Recommending if there is a need for recusal from voting on a particular study protocol related activity during PRMS committee meetings.
- Performs other duties and/or special projects to ensure departmental efficiency as assigned by Director, Office of Research Integrity and/or Lead PRMS Program Coordinator.
This facility is an equal opportunity employer and complies with federal, state and local anti-discrimination laws, regulations and ordinances. |
