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In-House Clinical Research Associate: Medidata RAVE
Ref No.: 18-03554
Location: Raritan, New Jersey
Position Type:Contract
Shift:First
Job Category:Biotech/Pharmaceutical
Benefits:Dental Insurance, Medical Insurance
*18 month contract to hire position*
 
Job Title In-house Clinical Research Associate (In-house CRA)
Location Raritan, NJ
Job summary The In-House Clinical Research Associate will work closely with the Lead CRA and Investigational Sites by providing support with clinical monitoring activities, assisting with the preparation, organization and follow-up of investigator, site communications and clinical monitoring tracking.
Primary responsibilities
  • Performs study tracking to ensure that all study files and documents are accurate, current and complete
  • Performs essential document collection, review, maintenance, and close-out activities, ensuring that sponsor and investigator obligations are being met and are in compliance with applicable local regulatory requirements, ICH/GCP guidelines and SOPs.
  • Provides general support to the Lead CRA in order to manage the investigator sites and ensure compliance
  • Performs recruitment plan review and provides regular enrollment updates
  • Addresses protocol questions and issues from investigational sites visits
  • Performs regular reviews of data according to data review/monitoring guidelines
  • Assists with resolution of investigational site/data queries.
  • Confirms and track that all key site personnel have project specific training.
  • Documents site and sponsor contact and study interactions in a timely and professional manner.
  • Provides assessment of sample status
  • Monitors tracking systems (CTMS, TMF, etc.)
Qualifications
  • Bachelor’s degree, in biological sciences or healthcare
  • 5+ years clinical trial experience (CRO, healthcare settings and industry experience are acceptable).
  • Excellent verbal and written communications skills; excellent interpersonal and organizational skills with demonstrated attention to detail.
  • Strong computer proficiency in MS Office including Word, Excel, and PowerPoint.
  • Ability to efficiently organize and prioritize work within a multifaceted framework and set deadlines.
  • Excellent organizational and record-keeping skills.
  • Ability to maintain excellent working relationships with a broad range of trial staff.
  • Knowledge of GCP as relates to clinical trial management
  • Ability to work well in a team environment but also independently without significant oversight. Flexibility in work hours and readiness to travel.
Preferred
  • Experience in Cardiovascular Therapeutic area
  • IVD studies
  • Medidata RAVE system
Travel
  • 10% on an annual basis
 
Pay Rate: $48.00 per hour
Drug and background screenings required


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