Research Projects Specialist, Senior

Nemours is looking for a Research Projects Specialist, Senior.

The role of Research Projects Specialist, Senior is to facilitate all clinical and translational research activities for the department, division, center, and/or assigned program.

This position will serve as a vital primary resource partner for investigators to facilitate the conduct of various research studies and liaise with research administration and various institutional committees.

The incumbent will serve as the lead point of contact for assigned areas and provide day-to-day support for ongoing studies, data management, publications, presentations, posters, and other academic work as assigned.

This position will also oversee projects and assumes significant responsibility for the operation of program activities, including the research design, conduct, analysis, interpretation of results and reporting of research studies and experiments.

Incumbent possesses advanced knowledge of research practices and directs and teaches others in those practices.

Qualifications:


* Bachelor's degree required; Master's preferred


* At least 5 years experience with clinical and translational research projects

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 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 pro...