Clinical Research Coordinator
Job Description
Clinical Research Coordinator in Emergency Department - Coordinates, implements and completes clinical research studies and/or clinical trials by assisting in regulatory document preparation and collection, in-servicing research teams, recruiting study participants, 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.
- 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.
- 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.
- 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.
- 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.
- Participates in training nursing and ancillary study staff for study purposes; builds relationships with various departments to ensure protocol compliance.
- Assists in identifying, reporting and following-up on Serious Adverse Events and/or Unanticipated problems.
- Assists in the maintenance of study medication accountability records; works closely with research pharmacist to coordinate study drug administration and documentation.
- Prepares clinical specimens for shipment to central laboratories. Ensures manual of procedures is followed and applicable documentation is sent with samples.
- 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.
- Participates in continuous process improvement initiatives and implementation of outcomes.
- Prepares for internal and external audits. Prepares corrective action plans as indicated.
Qualifications:
- At least 1 year Clinical Research Coordinator certification or eligible to sit for exam after 2 years clinical research coordination experience
- Bachelor's degree in medical or science related field required;
- Proficient in Microsoft software
- Experience with EPIC or similar EMR as used for research participants preferred
- Experience with TimeKeeper for Effort Reporting preferred
About Us
Nemours Children's Health is an internationally recognized children's 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 children's hospitals - Nemours Children's Hospital, Delaware and Nemours Children's 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, we're on a journey to discover better ways of approaching children's health. Putting as much focus on prevention as cures and working hand in hand with the community to make every child's world a place to thrive. It's 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 Children's and how we go well beyond medicine, visit us at [click to reveal website link].