Description

Nemours is seeking a Clinical Research Coordinator to join our Nemours Children's Health team in Orlando, FL.

Clinical Research Coordinator inOncologysupporting the NCCBD (Nemours Center for Cancer & Blood Disorders) - coordinates, implements and completes clinical research studies and/or clinical trials by assisting in screening oncology patients, obtaining parental permission/assent/consent forms, educating parents/participants, scheduling and conducting study procedures, collecting and recording study data, maintaining detailed study records, interfacing with study sponsors, participation in sponsor study monitoring visits, prepare for and participate in internal and external research audits, maintain various research databases, process and shipment of research samples, participation in continuous process improvement initiatives in Central Florida.

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. Understands and can conduct clinical research studies that require but not limited to Emergent Access/Compassionate use, Multi-site clinical trials, conduct Investigator Initiated studies, Research Team training manuals
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. Supports NCCBDs NCORP: NCI Community Oncology Research Program across the Nemours enterprise.
5. Performs clinical data gathering, measurements and monitoring of data integrity, including data completeness, accuracy and quality. Maintains multiple study databases. Ability to be submit data proactively and address queries in a timely manner.
6. Participates in training nursing and ancillary study staff for study purposes; builds relationships with various departments to ensure protocol compliance.
7. Assists in identifying, reporting and following-up on Serious Adverse Events and/or Unanticipated problems
8. Assists in the maintenance of study medication accountability records; works closely with research pharmacist to coordinate study drug administration and documentation
9. Prepares clinical specimens for shipment to central laboratories. Ensures manual of procedures is followed and applicable documentation is sent with samples
10. Coordinates monitoring activities with Sponsors representative(s). Completes Case Report Forms; responds to sponsor queries, prepares for audits by sponsor, IRB and/or the FDA/DHHS.
11. Attendance at and participation in relevant clinical divisional/departmental activities to assure routine administrative procedures are followed. Further attendance at Sponsor Coordinator meetings as needed for study related training.
12. Prepares for internal and external audits. Prepares corrective action plans as indicated.

Qualifications

Bachelors degree in medical or science related field required; effectively uses Microsoft computer software; demonstrates ability to coordinate and establish priorities among diverse tasks; effectively communicates verbally and in writing

One to three years of experience

Clinical Research Coordinator certification or eligible to sit for exam after 2 years clinical research coordination experience

About Us

Nemours Childrens Health is an internationally recognized childrens health system. With more than 1.7 million patient encounters annually, we provide medical care in five states through two freestanding state-of-the-art childrens hospitals Nemours Childrens Hospital, Delaware and Nemours Childrens Hospital, Florida. Our pediatric network includes 80 primary-urgent-and specialty care practices and more than 40 hospitalists serving 19 affiliated hospitals. We generate annual revenues of more than $1.7 billion derived from patient services, contributions from the Alfred I. DuPont Trust, as well as other income.

As one of the nation's premier pediatric health systems, were on a journey to discover better ways of approaching childrens health. Putting as much focus on prevention as cures and working hand in hand with the community to make every childs world a place to thrive. Its a journey that extends beyond our nationally recognized clinical treatment to an entire integrated spectrum of research, advocacy, education, and prevention, leading to the healthiest generations of children ever.

Inclusion and belonging guide our growth and strategy. We are looking for individuals who are passionate about, and committed to, leading efforts to provide culturally relevant care, reducing health disparities, and helping build an inclusive and supportive environment. All of our associates are expected to ensure that these philosophies are embedded in their day-to-day work with colleagues, patients and families.

To learn more about Nemours Childrens and how we go well beyond medicine, visit us at www.nemours.org.