Location: Wilmington, Delaware
Academic / Research
Nemours is seeking a Clinical Research Coordinator to join our Nemours Children's Hospital team in Wilmington, DE.
Research Coordinator-General Pediatrics & Research
Description: The Clinical Research Coordinator-General Pediatrics & Research (CRC-GP&R) will serve as the main point of contact for General Pediatrics studies and other Research trials within Nemours Children's Health-DE. The CRC will also assist other clinical research Oncology teams in conducting assigned clinical research studies as assigned. The CRC will follow all aspects of Standard Operating Procedures and Good Clinical Practices in the conduct of clinical research. Achieves clinical research coordinator certification from ACRP or SOCRA after two years in the position. Participates in the conduct of parental permission/assent process when necessary. Ensure patient compliance with required visit schedule, document required clinical information for reporting to industry partners, Sponsor, FDA or other regulatory agencies. Maintain all appropriate study records in accordance with GCP and local policy and procedures. Collects and prepare documents as required by sponsoring agencies/companies. Performs clinical data gathering and measurements and monitoring of data integrity, including data completeness, accuracy and quality. Maintains multiple 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.
Additional responsibilities include but not limited to:
- Assists in identifying, reporting and following-up on Serious Adverse Events.
- Assists in the maintenance of study medication and accountability records
- 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.
- Partnering with pharmacy: Ensure drug availability, reconciliation
- Patient education including completion of drug diaries, drug administration
- Specimen collection, processing and shipping as needed
- Other CRC duties as assigned
- Bachelor's degree in medical or science related field required
- Clinical Research Coordinator certification or eligible to sit for exam after 2 years clinical research coordination experience
- Demonstrates ability to coordinate and establish priorities among diverse tasks;
- Pediatric healthcare experience preferred
- Hematology/Oncology experience preferred
- Excellent interpersonal skills, able to establish rapport with a wide range of people
- Excellent technology and administrative skills
- Excellent presentation skills
- Strong oral and written communication skills
- Demonstrated ability to execute tasks with minimal oversight
- Demonstrated ability to coordinate and complete activities across multiple functions
- Able to work independently - candidates should be self-motivated