Clinical Research Coordinator II

Nemours Children s Health
US - Delaware - Wilmington
October 26, 2024

The Clinical Research Coordinator II coordinates, implements and completes clinical research studies or clinical trials involving Morquio syndrome 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.

Requirements:

Bachelor's degree in medical or science related field
Minimum of 2 years clinical research coordination experience
Effectively uses Microsoft computer software
Demonstrates ability to coordinate and establish priorities among diverse tasks
Effectively communicates verbally and in writing

Essential Functions:

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, DSMB, Emergent Access, Conduct Investigator Initiated studies, Multi-site clinical trials, Research Team training manuals.
Achieves clinical research coordinator certification from ACRP or SOCRA.
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.
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 and measurements and monitoring of data integrity, including data completeness, accuracy and quality.
Maintains study databases
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.
Assists in identifying, reporting and following-up on Serious Adverse Events.
Assists in the maintenance of study medication accountability records; prepares clinical specimens for shipment to central laboratories.
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.

About Us

As one of the nation's premier pediatric health care systems, we've made a promise to do whatever it takes to prevent and treat even the most disabling childhood conditions.
It's a promise that extends beyond our nationally recognized clinical treatment to an entire integrated spectrum of research, advocacy, education, and prevention.

Equity, diversity, and inclusion 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 a diverse and inclusive environment.
All Nemours Associates are expected to ensure that these philosophies are embedded in their day-to-day work with colleagues, patients and families.

Nemours aspires to have its workforce and providers reflect the rich diversity of the communities we serve.
Candidates of diverse backgrounds, race and ethnicity, religion, age, gender, sexual orientation, and those committed to working with diverse populations and conversant in multicultural values are strongly encouraged to apply.
Please click here to review Nemours Anti-Racism Statement (nemours.org).

To learn more about Nemours and our commitment to treat every child as if they were our own, visit us at nemours.org.

Read the full job description and apply online on the recuiter's web-site

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