Clinical Research Project Manager Jobs in Delaware

Come join us - Nemours Children's Hospital, Delaware is seeking an APRN/PA to join our Clinical Research team. This APRN/PA will function independently and collaboratively to provide specialty medical care for patients from 0 through 20 years participating in Clinical Research Trials.  This position is Monday through Friday 8:30 am to 5:00pm with no nights or weekends.  

The incumbent will coordinate, implement and complete 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/examinations, collecting and recording study data, maintaining study records, interfacing with study sponsors, participation in sponsor study monitoring visits.  

Excellent written, phone, and interpersonal communication skills are required. Interested applicants should possess the ability to function at a high level in an interprofessional team environment as well as an independent provider. 

Essential Functions Include:

1. Assessment, diagnosis, management, and follow up visits for patients enrolled in Clinical Research projects.
2. Provide concise documentation of patient encounters including diagnoses, management strategies and follow up plan.
3. Identifies patient and family needs for additional resources and initiates appropriate referrals. 
4. Provides patient and family teaching based on identified learning needs. 
5. Evaluates compliance with the prescribed treatment regimen through phone calls, emails, app messaging, patient/family assessments, and outpatient visits as needed. 
6. Acts as patient advocate and liaison. 
7. Acts as role model for other office members to foster professional development. 
8. Utilizes advanced knowledge and specialized skill in nursing practice in accordance with the state law, hospital bylaws, and hospital policy. 
9. Demonstrates proficiency in the care of all age groups Including neonates, Infants, toddlers, school-aged children, adolescents, and young adults.
10. Responsible for participation in departmental initiatives and programmatic development including the identification of opportunities to improve services, offer recommendations, and implement actions as appropriate and consistent with the goals of the Nemours Foundation. 
11. 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.
12. Performs clinical data gathering and measurements and monitoring of data integrity, including data completeness, accuracy and quality.  Maintains study databases.
13. Mentors new clinical research coordinators. 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.
14. Assists in identifying, reporting and following-up on Serious Adverse Events. 
15. Assists in the maintenance of study medication accountability records; prepares clinical specimens for shipment to central laboratories.
16. 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.

Requirements:

• Must be a graduate of an accredited Pediatric Nurse Program (or) graduate of an accredited Physician Assistant Program 
• Three years of related pediatric Advanced Practice clinical experience preferred.
• Current unrestricted Advanced Registered Nurse Practitioner License or Physician Assistant license to practice in the state(s) in which privileges are sought (DE  and PA); Pediatric Nurse Practitioner Certification via National Certification Center; BLS and PALS Certification upon hire. 
• DE CSR, DE DEA, PA DEA
• Additional state licensure may be required.

Questions?  Please contact Megan at Megan.Roberts@nemours.org

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