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Study Start-up Specialist

Job Attributes

Job Id:

34250

Job Category:

Clinical & Life Sciences

Job Location:

Durham, NC  

Security Clearance:

None

Business Unit:

Piper Companies

Division:

Piper Clinical Solutions

JOB DESCRIPTION

Piper Companies is seeking an experience Study Start-Up Specialist to work with a large, global Clinical Research Organization in the RTP area of North Carolina (NC). This is a full-time, Monday through Friday 8am-5pm position.


Responsibilities of the Study Start-up Specialist Include:

·      Responsible for all study start-up deliverables including lifecycle maintenance and amendment activities, consistent communication and coordination with country teams and site contract negotiators, and other responsibilities as assigned

·      Oversee the creation and dissemination of all required regulatory documentation for sites including regulatory binders, Informed Consent Forms, and Clinical Report Forms

·      Coordinate with monitors to identify any gaps in start-up processes to ensure sites have required materials, resources, and training to initiate the trial


Qualifications of the Study Start-up Specialist Include:

·      3-5 years of experience in Clinical Research focusing on start-up or regulatory aspects of clinical trials

·      Strong understanding of regulatory requirements including ICH GCP

·      Experience authoring or handling IEC and IRB submission deliverables

·      BS Degree required, preferably in a medical or life sciences field


Compensation of the Study Start-up Specialist Include:

·      $50,000-$70,000 based on past experience and education levels

·      Full Benefits: Medical, Dental, Vision, 401k


Keywords:

Start-up, site, study, clinical trial, regulatory, IRB, IEC, institutional review board, submission, informed consent, ICF, country, CRF, clinical report forms, training, ICH, GCP, clinical research, benefits, medical, dental, vision, 401k, North Carolina, NC

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Job Id:

34250

Job Category:

Clinical & Life Sciences

Job Location:

Durham, NC  

Security Clearance:

None

Business Unit:

Piper Companies

Division:

Piper Clinical Solutions