The Clinical Research Coordinator coordinates, implements and completes clinical research studies or clinical trials by assisting with IRB submissions, assisting in regulatory document preparation and collection, in-servicing research teams, recruiting study participants, obtaining parental permission/assent, educating parents/participants, scheduling and conducting study procedures, collecting and recording study data, maintaining study records, interfacing with study sponsors, participation in sponsor study monitoring visits.
Job Details include, but not limited to:
Follows all aspects of Standard Operating Procedures and Good Clinical Practices in the conduct of clinical research; collects and prepares documents as required by sponsoring agencies; attends Investigator Meetings, as assigned.
Supporting NCCBD's NCORP: NCI Community Oncology Research Program across the Nemours enterprise.
Develops source documents, parental permission, and assent documents for submission to IRB. Coordinates IRB submissions for assigned studies, maintains regulatory documents during conduct of study; develops and uses study participant and family teaching tools for study purposes; interfaces with representatives of sponsoring agencies.
Participates in the conduct of parental permission/assent process for assigned studies; schedules study visits with study participants following study protocols; develops strategies to assure compliance of study participants with protocol requirements.
Performs clinical data gathering and measurements and monitoring of data integrity, including data completeness, accuracy, and quality. Maintains study databases
Participates in training nursing and ancillary study staff for study purposes; recruits, screens and enrolls sufficient number of study participants in conformance with protocol requirements.
Assists in identifying, reporting and following-up on Serious Adverse Events.
Assists in the maintenance of study medication accountability records; prepares clinical specimens for shipment to central laboratories.
Coordinates monitoring activities with Sponsor's representative(s). Completes Case Report Forms; responds to sponsor queries, prepares for audits by sponsor, IRB and/or the FDA/DHHS.
Additional Skills and Abilities:
General knowledge of office and clinic practices and organization policies
Strong understanding of medical terminology, anatomy, physiology, clinical medicine, surgery, diagnostic tests, radiology, pathology, pharmacology, hematology, and oncology
Ability to read and interpret various documents and manuals such as protocols, informed consents, and regulatory documentation
Familiarity with the Code of Federal Regulations as they pertain to human subject clinical research
Proficiency in computer software applications, including Microsoft Excel, and Microsoft Word and internet programs
Excellent reading and writing skills
Ability to work independently, problem solve, and deal with a variety of situations; detail-oriented
Familiar with database programs and data entry
Ability to communicate both effectively and professionally with location staff and patients
Ability to maintain strict confidentiality of practice and/or patient information
Qualifications:
Bachelor's degree required
Hematology or Oncology: 1 year
Clinical Research: 2 years (Preferred)
Clinical Research Coordinator: 1 year (Preferred)
Compensation and Benefits:
Salary is commensurate with experience and qualifications
Nemours is an "EEO Employer" and "Drug Free Workplace"
Nemours is committed to improving the health of children. As a non-profit children’s health organization, we consider the health of every child to be a sacred trust. Through family-centered care in our children’s hospitals and clinics in Delaware, New Jersey, Pennsylvania and Florida, as well as world-changing research, education and advocacy, Nemours fulfills the promise of a healthier tomorrow for all children — even those who may never enter our doors. Nemours began more than 70 years ago with the vision of Alfred I. duPont to improve the lives of children and to do whatever it takes to prevent and treat even the most disabling childhood conditions. Today, through our children’s hospitals and health system, we directly care for 250,000 children annually in Delaware Valley and Florida, including families who travel from across the country and world to see our specialists — treating every child as we would our own. We also reach beyond the walls of our hospitals and clinics to be a voice for children on a national and international level, and to lead the way in prevention, intervention, education, and research. Nemours is growing to better serve the children and families in our ca...re. We have 1.1 million square feet of space currently devoted to providing children’s healthcare or under construction, all designed with significant input and advice from our patients and families.
