CLINICAL RESEARCH ASSOCIATE (CONTRACT STATUS)

 Meso Scale Diagnostics, LLC. (MSD) develops, manufactures and markets products for biological detection and measurement. The Company’s proprietary Multi-Array™ platform enables simple, rapid, sensitive, and simultaneous measurements of multiple analytes from a single biological sample. MSD offers a full line of instruments, reagents and services that provide important and valuable solutions for biological sample analysis. MSD’s headquarters are located in Gaithersburg, Maryland.

Position Summary:

The Clinical Research Associate will support the Clinical Research department by monitoring activities of study sites and some in-house monitoring of study-related documents.  This includes:

• Collect and review essential documents for study start-up
  
• Monitoring activities (initiation, interim, and close-out visits) at clinical study sites to assure adherence to GCPs, SOPs, and study protocols.
  
• Interact with investigators and study site personnel.
  
• Prepare site visit reports.
  
• Maintain internal trial master file to ensure inspection readiness.
  
• Assist in the preparation of the protocols, CRFs (including completion guidelines), template informed consent forms, and other documentation required for the conduct of the clinical trial.
  
• Review clinical data in-house and issue clarification requests to study sites.

  Requirements:

Qualifications:

·         Ability to travel 40%, depending on project needs

·         Excellent interpersonal and organizational skills

·         Attention to detail

·         Computer literacy, proficiency in MS Office

Experience:

·         Medical device experience, preferably with in vitro diagnostic (IVDs) devices Class I/II

·         Minimum 2 years experience as an in-house CRA (medical device trials)

·         Minimum 2 years field monitoring experience (medical device trials)

·         BS/MS degree in science or other field. 

 www.mesoscale.com

Please refer to job reference #: 09-CRA-TEMP-10

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This policy applies to all areas of employment, including recruitment, hiring, training and development, promotion, transfer, termination, layoffs, compensation, benefits and all other terms, conditions and privileges of employment.