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Clinical Research Coordinator
4 months ago
The Clinical Research Coordinator 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:
- Bachelor's 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
- Clinical Research Coordinator certification or eligible to sit for exam after 2 years clinical research coordination experience
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 www.nemours.org.
