Responsible for clinical trials management and research compliance. Audits program for research compliance.
- Assures adherence to all research standards as set forth by the Food and Drug Administration (FDA), the Office for Human Research Protections (OHRP), Radiology Imaging Associated (RIA) and other pertinent regulatory agencies.
- Works well as a member of the clinical research team by positive and timely written and verbal communication with appropriate team members.
- Reviews protocol inclusion/exclusion criteria, and confirms eligibility of subject.
- Ensures that the informed consent process has occurred, is properly documented and filed as required.
- Recruits and interviews prospective subjects for clinical studies. Familiarizes potential subjects with the details of the study through phone contacts and personal interviews.
- Recognizes adverse events and serious adverse events and promptly notifies appropriate parties; e.g. Principal Investigator, Study Sponsor, and IRB.
- Serves as a contact person for ongoing clinical research studies.
- Meets with representatives from sponsoring pharmaceutical firms and their designees or in-house staff for initial orientation to studies and for review of study records.
- Prepares for and conducts monitor visits, answering questions and resolving issues in a timely manner. Prepares for and conducts study closure visits.
- Submits complete and accurate initial clinical research applications to all required regulatory bodies for the conduct of clinical research.
- Completes and submits continuing reviews of research as directed by the respective IRB and recognizes the importance of these being submitted on time in order to avoid expiration of the study.
- Prepares and submits amendments and revisions from sponsors and investigators to the respective IRB and ensures that research staff are appropriately trained and have the appropriate documents.
- Writes clear and accurate subject informed consent documents and HIPAA (Health Insurance Portability and Accountability Act) Authorizations.
- Prepares and collates materials stored in the regulatory binder including all pertinent regulatory documents, correspondence and approved documents.
- Keeps the research intranet up to date and keep all study staff advised of changes and updates.
- Assists Manager in assessing study feasibility, reviewing study budgets and sponsor communications.
- Engages with sponsors, our in house investigators and others to develop new research opportunities.
- Keeps up with continuing education opportunities by attending SOCRA Conferences or other educational opportunities as available.
- Responsible for conducting the full range of activities assisting in the writing, preparing, submitting, and managing grant proposals to ACRIN, NIH, NCI and others as appropriate.
- Manages multiple projects and meet deadlines while paying close attention to detail and accuracy.
- Other duties as assigned.
- Minimum of two years prior experience as Clinical Research Coordinator.
- Strong computer and analytical skills, including MS Word, Excel, Outlook, Access and PowerPoint; ability to type a minimum of 45 words per minute.
- Strong communication skills both written and verbal.
- Bachelor’s degree
- Clinical Research Professional Certification (SOCRA or ACRP)
- CITI Training (may be completed upon hire)
RIA/Invision Sally Jobe - 12 months ago
Radiology Imaging Associates (RIA) has been a progressive provider of professional services for diagnostic imaging in the South Denver area...