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Clinical Research Associate III (CRA III) - NJ
Ref No.: 18-03309
Location: Raritan, New Jersey
Start Date / End Date: 05/29/2018 to 11/15/2019
Job Description & Requirements
Job Type: Recruited Resource - Project-Based Temp Number of Positions: 1
System Location: OCD - 6118 Created Date: 5/9/2018
Job Title: Clinical Research Associate III (CRA III) - NJ
CWR Type: W-2 Reason: New Position

Qualifications:
IN-HOUSE CLINICAL RESEARCH ASSOCIATE - SEE JOB DESCRIPTION ATTACHED. Generally requires (5+) years related experience.

Responsibilities:
IN-HOUSE CLINICAL RESEARCH ASSOCIATE - SEE JOB DESCRIPTION ATTACHED.

Comments/Special Instructions
Looking for In-House CRA candidates with significant US-based experience. This requisition replaces Job 2673. If your candidates were declined on Req. 2673, please do not submit to this position. Also, please make sure any candidates submitted are within a reasonable commute to Raritan, NJ. Thanks.
Work Location: 1001 US Highway 202 USRAR, Raritan, NJ 08869 United States
Start Date: 5/29/2018 Work Days:
Sun Mon Tue Wed Thu Fri Sat
End Date: 11/15/2019
Start Time: 8:00 AM Total Reg Hours: 40.00
End Time: 5:00 PM Overtime Required:
Lunch Time: 1 Hour


Attached Documentation:

Job Title In-house Clinical Research Associate (In-house CRA)
Position type 18 Month Contract (with possible extension)
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