Clinical Research Administrator

6 days ago


Orlando, Florida, United States Orlando Health Full time
Job Summary

The IRB Coordinator II is a key member of the research compliance team at Orlando Health, responsible for ensuring the integrity and quality of research studies involving human subjects. This role requires a strong understanding of regulatory guidelines and the ability to apply them in a practical setting.

Key Responsibilities
  • Review and approve research protocols to ensure compliance with regulatory requirements, including those of the FDA, OHRP, and NIH.
  • Manage the review process for research submissions, including the preparation of meeting agendas, recording of meeting minutes, and issuance of IRB determination letters.
  • Coordinate submissions for expanded access treatment uses, such as single-patient INDs and compassionate uses.
  • Provide guidance and support to less experienced staff members, including training and mentorship.
  • Collaborate with the Principal Investigator, IRB members, corporate research, funding entities, and ancillary review committees to ensure compliance with regulatory requirements.
  • Respond to queries from research departments and resolve any issues that may arise.
  • Assess and evaluate trial progress for study renewals, closures, deviations, and other events.
  • Issue queries requesting additional information and revisions to IRB submissions, and review and evaluate responses to ensure requests for changes have been satisfied.
Qualifications
  • Bachelor's degree required.
  • Eligibility for certification as a Certified IRB Professional (PRIM&R), Certified IRB Manager (CIM), Certified Clinical Research Professional (SoCRA), or Certified Clinical Research Coordinator (ACRP) is highly desirable.
  • Four (4) years of experience in IRB, clinical research, or a related field is required.

  • Compliance Director

    4 days ago


    Orlando, Florida, United States Charter Research Full time

    Job SummaryWe are seeking a highly experienced Compliance Director to lead our Clinical Research Operations team at Charter Research. As a key member of our organization, you will be responsible for ensuring the highest standards of compliance and regulatory excellence in all our clinical research activities.Key ResponsibilitiesDevelop and implement quality...


  • Orlando, Florida, United States CHARTER RESEARCH Full time

    Job SummaryCharter Research is a leading clinical research organization seeking a highly skilled and detail-oriented Clinical Research Coordinator to join our team. As a Clinical Research Coordinator, you will play a critical role in the success of our clinical trials by assessing potential new patients for optimal trial placement and providing exceptional...


  • Orlando, Florida, United States CHARTER RESEARCH Full time

    Job OverviewCompany OverviewCharter Research is a dynamic and rapidly expanding clinical research organization dedicated to advancing medical science. We focus on delivering exceptional experiences for our participants while implementing effective recruitment strategies for our sponsors. Our team is built on collaboration, and we are looking for a dedicated...


  • Orlando, Florida, United States CHARTER RESEARCH Full time

    Job OverviewCompany OverviewCharter Research is a dynamic and rapidly expanding clinical research organization dedicated to the advancement of medical science. We focus on delivering exceptional experiences for our participants while implementing effective recruitment strategies for our sponsors. Our team-oriented culture is essential to our mission of...


  • Orlando, Florida, United States CHARTER RESEARCH Full time

    Job OverviewCompany BackgroundCharter Research is a rapidly expanding clinical research organization dedicated to the advancement of medical science. Our focus is on delivering exceptional experiences for our participants while implementing effective recruitment strategies for our sponsors. We are committed to building a cohesive team that embodies our...


  • Orlando, Florida, United States Nemours Children's Health Full time

    Job OverviewClinical Research Specialist (Open Rank)Nemours Center for Healthcare Delivery Science The Nemours Center for Healthcare Delivery Science (CHDS) is in search of a Clinical Research Specialist (Open Rank) based in Florida. Healthcare delivery science encompasses the utilization of scientific methodologies and principles to evaluate the variables...


  • Orlando, Florida, United States Actalent Full time

    Job Title: Clinical Research SupervisorM-F schedule - day shift - onsite in OrlandoJob DescriptionThe Clinical Research Supervisor provides oversight of the conduct of industry-sponsored and investigator-initiated clinical trials in accordance with trial protocols, Food and Drug Administration (FDA) regulations, and International Conference on...


  • Orlando, Florida, United States AdventHealth Full time

    All the benefits and perks you need for you and your family: Benefits from Day One Paid Days Off from Day One Student Loan Repayment Program 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...


  • Orlando, Florida, United States Nemours Full time

    The Clinical Research Nurse II plays a pivotal role in the coordination, execution, and completion of clinical research initiatives and trials. This position involves assisting in the preparation and collection of regulatory documents, training research teams, recruiting participants, and obtaining necessary permissions and consents. The nurse will educate...


  • Orlando, Florida, United States CHARTER RESEARCH Full time

    Job OverviewCompany BackgroundCharter Research is a rapidly expanding clinical research organization dedicated to advancing medical science. We pride ourselves on delivering outstanding patient experiences and implementing effective recruitment strategies for our sponsors. Our commitment to teamwork is at the core of our operations, and we are looking for a...


  • Orlando, Florida, United States CHARTER RESEARCH Full time

    Job OverviewCompany OverviewCharter Research is a rapidly expanding clinical research organization dedicated to advancing medical science through innovative research initiatives. We are committed to delivering exceptional patient experiences and implementing effective recruitment strategies for our partners.Position SummaryThe Clinical Operations Supervisor...


  • Orlando, Florida, United States CHARTER RESEARCH Full time

    Job OverviewCompany OverviewCharter Research is a dynamic and rapidly expanding clinical research organization dedicated to the discovery of innovative therapies. We pride ourselves on delivering outstanding patient experiences and implementing effective recruitment strategies for our partners.Position SummaryThe Clinical Operations Supervisor is tasked with...


  • Orlando, Florida, United States Alcanza Clinical Research Full time

    Job OverviewAlcanza Clinical Research is a dynamic and expanding organization specializing in multi-site clinical trials across various therapeutic areas. We are seeking a meticulous and proactive Staff Accountant to play a vital role in our General Accounting and Financial Reporting activities.Key ResponsibilitiesThe selected candidate will be instrumental...


  • Orlando, Florida, United States Colorado Mountain College Full time

    Responsibilities: Oversees the management of Research Support Agreements for the designated area. Develops and sustains Research Support Agreements (RSAs) for multiple research divisions. Collaborates closely with Research Leaders, Scientists, and Administrative Support Staff to create RSAs that will be financed through federal appropriations and/or...


  • Orlando, Florida, United States Actalent Full time

    Job Title: Clinical Research Supervisor Job DescriptionThe Clinical Research Supervisor serves the Research Institute by overseeing the conduct of industry-sponsored and investigator-initiated clinical trials. This role ensures compliance with trial protocols, FDA regulations, and ICH/GCP guidelines. The supervisor functions as a clinical study coordinator...


  • Orlando, Florida, United States Actalent Full time

    Job Title: Clinical Research CoordinatorJob Description The Clinical Research Coordinator, under limited supervision, plans, coordinates, evaluates, and performs the care of participants and collects data for assigned research projects. The CRC-II (Non-RN) follows study-specific protocol guidelines, communicates with Principal Investigators (PI),...


  • Orlando, Florida, United States Nemours Full time

    Position Overview Company: Nemours As a Clinical Research Specialist, you will play a pivotal role in advancing medical knowledge and patient care through rigorous scientific inquiry. This position offers an opportunity to contribute to groundbreaking research initiatives that impact healthcare outcomes. Key Responsibilities Design and implement...


  • Orlando, Florida, United States Actalent Full time

    Job Title: Clinical Research Coordinator II*This is a fully on-site position in Orlando, FloridaJob DescriptionThe Clinical Research Coordinator (Non-RN) manages all aspects of research, including patient screening, eligibility assessment, and coordination of care and follow-up for volunteers in research studies, trials, and programs. Key activities include...


  • Orlando, Florida, United States Actalent Full time

    Job Title: Clinical Research Coordinator II*This is a fully on-site position in Orlando, FloridaJob DescriptionThe Clinical Research Coordinator (Non-RN) manages all aspects of research, including patient screening, eligibility assessment, and coordination of care and follow-up for volunteers in research studies, trials, and programs. Key activities include...


  • Orlando, Florida, United States Medix™ Full time

    We are seeking a dedicated Research Support Specialist to enhance our dynamic team at Medix™. This is a full-time, onsite opportunity that comes with a competitive salary, potential bonuses, and an extensive benefits package. If you are eager to be part of a national organization that offers significant growth opportunities, this position may be ideal for...