N
Clinical Research Coordinator
Nemours Children's Health
10 hours ago
Full-time
On-site
Wilmington, Delaware, United States
Registered Nurse
Primary Function
The Nemours Anesthesia and Surgical Outcomes Center (NASOC) Clinical Research
Coordinator will support clinical research activities for the department,
division, and/or center. This position will serve as a vital resource for
investigators to partner and facilitate the conduct of various research studies
and liaison with research administration as well as various institutional
committees. The incumbent will serve as a point of contact for assigned areas
and provide day-to-day support to the ongoing studies, publications,
presentations, posters, and other academic work as assigned. As a result, the
clinical research coordinator will help to advance research throughout the
department and divisions as assigned. This position will also support projects
and assumes responsibility for the day-to-day operation of program activities,
including the regulatory functions, project management, administrative tasks,
study conduct, chart review, study enrollment, basic data analysis, RedCap,
interpretation of results and reporting of research studies and experiments.
Possesses advanced knowledge of research practices.
Essential Functions
1. Follows all aspects of Standard Operating Procedures and Good Clinical
Practices in the conduct of clinical research; collects and prepares
documents as required to ensure compliance with sponsor and regulatory
guidelines; oversee clinical research projects within the department and
divisions.
2. 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.
Maintains scientific knowledge and understanding of peer-reviewed
publications for application to current methodologies.
3. Participates in the design and completion of study protocols; including but
not limited to regulatory support and maintenance, the conduct of parental
permission/assent process for assigned studies; enrolls study participants;
schedules study visits with study participants in accordance with study
protocols; develops strategies to assure compliance of study participants
with protocol requirements.
4. Performs clinical data gathering, measurements including medical record
review when needed and monitoring of data integrity, including data
completeness, accuracy, and quality. Maintains and contributes to the
creation of multiple study databases, including but not limited to RedCap.
Ability to submit data proactively, address queries in a timely manner, and
identify and resolve concerns related to research projects.
5. Participates in training study team members for study purposes; builds
relationships with various departments to ensure protocol compliance.
6. Assists in identifying, reporting and following-up on Serious Adverse Events
and/or Unanticipated problems
7. Assists in the maintenance of study medication accountability records; works
closely with research pharmacist to coordinate study drug administration and
documentation.
8. Prepares clinical specimens for shipment to central laboratories. Ensures
manual of procedures is followed and applicable documentation is sent with
samples
9. Coordinates monitoring activities with Sponsor’s representative(s).
Completes Case Report Forms; responds to sponsor queries, prepares for
internal and external audits by sponsor, IRB and/or the FDA/DHHS.
10. Participates in continuous process improvement initiatives and
implementation of outcomes. Advise and collaborate with Principal
Investigators on strategies to enhance research activity.
11. Provide non-technical writing, formatting, and editing support; inclusive
of budget justifications, biographical sketches, institutional background
descriptions, references, appendices, and other proposal documents. Assist
the PI and research team prepare presentations for scientific meetings,
describing the methodology and results; prepare manuscripts for publication
in peer-reviewed journals; and prepare grant applications.
Requirements
* Bachelor’s degree in medical or science related field required;
* At least one year of Research experience 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
#LI-RR1
Nemours Children's Health is an internationally recognized pediatric health
system serving more than 1.7 million patient encounters each year. We deliver
care across six states through two freestanding children’s hospitals — Nemours
Children's Hospital, Delaware and Nemours Children's Hospital, Florida — along
with a network of more than 80 primary, urgent, and specialty care practices and
more than 40 hospital partnerships.
Backed by the Nemours Foundation and Alfred I. duPont Trust, our $1.7B nonprofit
system is dedicated to improving children's health through clinical care,
research, education, advocacy, and prevention. Our Whole Child Health approach
focuses equally on prevention and treatment, partnering with communities to help
every child thrive.
Inclusion and belonging guide our strategy and growth. We are committed to
culturally relevant care, reducing health disparities, and fostering an
environment where every associate, patient, and family feels supported and
valued.
Learn more at Nemours.org [https://www.nemours.org/].
The Nemours Anesthesia and Surgical Outcomes Center (NASOC) Clinical Research
Coordinator will support clinical research activities for the department,
division, and/or center. This position will serve as a vital resource for
investigators to partner and facilitate the conduct of various research studies
and liaison with research administration as well as various institutional
committees. The incumbent will serve as a point of contact for assigned areas
and provide day-to-day support to the ongoing studies, publications,
presentations, posters, and other academic work as assigned. As a result, the
clinical research coordinator will help to advance research throughout the
department and divisions as assigned. This position will also support projects
and assumes responsibility for the day-to-day operation of program activities,
including the regulatory functions, project management, administrative tasks,
study conduct, chart review, study enrollment, basic data analysis, RedCap,
interpretation of results and reporting of research studies and experiments.
Possesses advanced knowledge of research practices.
Essential Functions
1. Follows all aspects of Standard Operating Procedures and Good Clinical
Practices in the conduct of clinical research; collects and prepares
documents as required to ensure compliance with sponsor and regulatory
guidelines; oversee clinical research projects within the department and
divisions.
2. 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.
Maintains scientific knowledge and understanding of peer-reviewed
publications for application to current methodologies.
3. Participates in the design and completion of study protocols; including but
not limited to regulatory support and maintenance, the conduct of parental
permission/assent process for assigned studies; enrolls study participants;
schedules study visits with study participants in accordance with study
protocols; develops strategies to assure compliance of study participants
with protocol requirements.
4. Performs clinical data gathering, measurements including medical record
review when needed and monitoring of data integrity, including data
completeness, accuracy, and quality. Maintains and contributes to the
creation of multiple study databases, including but not limited to RedCap.
Ability to submit data proactively, address queries in a timely manner, and
identify and resolve concerns related to research projects.
5. Participates in training study team members for study purposes; builds
relationships with various departments to ensure protocol compliance.
6. Assists in identifying, reporting and following-up on Serious Adverse Events
and/or Unanticipated problems
7. Assists in the maintenance of study medication accountability records; works
closely with research pharmacist to coordinate study drug administration and
documentation.
8. Prepares clinical specimens for shipment to central laboratories. Ensures
manual of procedures is followed and applicable documentation is sent with
samples
9. Coordinates monitoring activities with Sponsor’s representative(s).
Completes Case Report Forms; responds to sponsor queries, prepares for
internal and external audits by sponsor, IRB and/or the FDA/DHHS.
10. Participates in continuous process improvement initiatives and
implementation of outcomes. Advise and collaborate with Principal
Investigators on strategies to enhance research activity.
11. Provide non-technical writing, formatting, and editing support; inclusive
of budget justifications, biographical sketches, institutional background
descriptions, references, appendices, and other proposal documents. Assist
the PI and research team prepare presentations for scientific meetings,
describing the methodology and results; prepare manuscripts for publication
in peer-reviewed journals; and prepare grant applications.
Requirements
* Bachelor’s degree in medical or science related field required;
* At least one year of Research experience 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
#LI-RR1
Nemours Children's Health is an internationally recognized pediatric health
system serving more than 1.7 million patient encounters each year. We deliver
care across six states through two freestanding children’s hospitals — Nemours
Children's Hospital, Delaware and Nemours Children's Hospital, Florida — along
with a network of more than 80 primary, urgent, and specialty care practices and
more than 40 hospital partnerships.
Backed by the Nemours Foundation and Alfred I. duPont Trust, our $1.7B nonprofit
system is dedicated to improving children's health through clinical care,
research, education, advocacy, and prevention. Our Whole Child Health approach
focuses equally on prevention and treatment, partnering with communities to help
every child thrive.
Inclusion and belonging guide our strategy and growth. We are committed to
culturally relevant care, reducing health disparities, and fostering an
environment where every associate, patient, and family feels supported and
valued.
Learn more at Nemours.org [https://www.nemours.org/].