As one of the nation's leading pediatric health care systems, Nemours is committed to providing all children with their best chance to grow up healthy. We offer integrated, family-centered care to more than 300,000 children each year in our pediatric hospitals, specialty clinics and primary care practices in Delaware, Florida, Maryland, New Jersey and Pennsylvania. Nemours strives to ensure a healthier tomorrow for all children â“ even those who may never enter our doors â“ through our world-changing research, education and advocacy efforts. At Nemours, our Associates help us deliver on the promise we make to every family we have the privilege of serving: to treat their child as if they were our own.
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.
1. 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;
2. 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 utilizes study participant and family teaching tools for study purposes; interfaces with representatives of sponsoring agencies.
3. Participates in the conduct of parental permission/assent process for assigned studies; schedules study visits with study participants in accordance with study protocols; develops strategies to assure compliance of study participants with protocol requirements.
4. Performs clinical data gathering and measurements and monitoring of data integrity, including data completeness, accuracy and quality. Maintains study databases
5. 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.
6. Assists in identifying, reporting and following-up on Serious Adverse Events.
7. Assists in the maintenance of study medication accountability records; prepares clinical specimens for shipment to central laboratories.
8. 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.
Attendance at and participation in relevant clinical divisional/departmental activities to assure routine administrative procedures are followed.
Attendance at Sponsor Coordinator meetings as needed for study related training.
Other duties as assigned.
1. Ability to set and meet deadlines; ability to maintain and organize multiple open clinical protocols 2. Conforms to Standard Operating Practices (SOPs) and Good Clinical Practice guidance; provides constructive critical assessments of proposed studies; seeks clarification of established policy prior to taking unauthorized action 3. Maintains the highest possible standards for work quality; accepts feedback; gives accurate information 4. Builds and fosters professional relationships with staff, families and patients 5. Makes decisions when appropriate; manages resources prudently; schedules time efficiently; works independently 6. Sets priorities; takes direction; thinks pro-actively; demonstrates adaptability/resourcefulness 7. Realizes and accepts limitations
Knowledge, Formal Education, and Training
Minimum 1 - 3 years job related experience. Must sit for ACRP Certification exam as soon as eligible.
EMR as used for research participants; TimeKeeper for Effort Reporting
Licenses, Registrations, or Certifications Required:
Bachelors degree or higher in clinical or life science related field; must meet minimum internal clinical research competencies and prepare and sit for ACRP Certification exam as soon as eligible.
Our dedication to professionals who are dedicated to children frequently earns Nemours a spot on the list of top workplaces in the communities we serve. Our Associates enjoy comprehensive benefits, including our unique âœBridge to a Healthy Futureâ pediatric health plan, an integrated wellness program, opportunities for professional growth, and much more. As an equal opportunity employer, Nemours focuses on the best-qualified applicants for our openings.