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Hours Full-time, Part-time
Location Durham, NC
Durham, North Carolina

About this job

Requirment: candidates must have experinece working as a Clinical Research Coordinator and be a RN.

Position details: this is a part time position where the candidate should expect to work 30 hours a week.

Primary Purpose:
The primary purpose of this position will be to run all aspects of the assigned clinical trials. IRB submissions, recruitment, working with investigators as well as the patients.
Duties and Responsibilities:
-Perform independent and dependable work in preparation and coordination of study submission to IRB and other appropriate committees following regular deadlines. They will provide draft IRB, Sponsor and other response to the PI for approval. They will respond on behalf of the PI when appropriate
-Communicate with study staff, IRB, sponsors, domestic and international study partners in a courteous and professional manner; Meet with study sponsor representatives as needed. Attend IRB, study sponsor, or any other meeting in place of the PI
-Prepare informed consent forms that follow appropriate regulation and meet sponsor requirements
-Address queries and memos from IRB and other committees create draft response to query's for PI approval
-Maintain and organize electronic and paper regulatory documents, study files and patient binders.
-Perform Quality Assurance/Quality Control of Study files
-Track and enter regulatory submissions using electronic databases and prepare reports within the databases. Respond to all queries and adverse events in a timely manner. Will be initial contact for all adverse events for their studies
-See clinical trial patients, follow up with phone calls and make sure all protocols are followed. Will also be responsible for screening and recruitment of clinical trial patients
-Communicate for themselves and on behalf of the PI potential issues to regulatory supervisor, study team members, investigators
-Assist other staff members in completion of work in a team oriented fashion
-Complete other regulatory duties as assigned.
-Communication, Teamwork and Compliance
-Employee uses effective verbal and written communication to accomplish tasks

About Aerotek:

Aerotek, headquartered in Hanover, Md., is a leading provider of technical, professional and industrial staffing services.  Established in 1983, Aerotek is an operating company of Allegis Group, the largest provider of staffing services in the U.S. Aerotek operates a network of more than 200 non-franchised offices throughout the U.S., Canada and Europe. For more information, visit .