Job Title: Clinical Research Associate (Levels I – III)  – Open to FT/PT

 

Department: Operations

 

Purpose of position:  The Clinical Research Associate (CRA) will report directly to the Head  of Clinical Trials but will have significant matrix interaction with the RA/QA, Development, Marketing, and Operations departments. The CRA is responsible for implementation of the clinical trials/research activities for IVD assays and for assisting with any necessary CRO activity. The CRA will receive and monitor clinical data as appropriate and is responsible for assurance of compliance with protocols and overall clinical objectives according to all applicable regulations, e.g. ICH and GCP guidelines.

 

The CRA will have responsibility for writing and reviewing protocols, maintaining auditable clinical trial files, monitoring clinical trial sites (both at a clinical site and in house), writing and reviewing clinical reports.  Travel may be involved. Candidate must have excellent interpersonal skills and be able to multitask while working with colleagues from multidisciplinary areas of expertise.  

 

Primary Responsibilities and Duties:

• Manage clinical trials through to completion.  This may involve documentation of the Study Plan, the Clinical Protocol, and Case Report Forms.

• Coordinate and distribute study materials.

• Maintain study management forms, clinical trial files, training plan, and monitoring plan.  Document activities and progress on each of these.

• Act as the main line of communication among Landrich Group, the Investigator, the Investigational Site, and Regulatory/Clinical consultants. Perform site visits as required.

• Ensure applicable clinical trials are appropriately entered into the US National Institutes of Health (NIH) clinicaltrials.gov registry.  Document the reasoning if the trial is not determined to be “applicable”.

• Review data, create the database, and review database to ensure accurate reporting of data.

• Lock database.

• Ensure the trial data are accurate, complete, and verifiable from source documents.

• Assist in the creation of the Product Insert or Instructions For Use.

• Participate in writing the Final Study Reports.

• Assist in preparation of regulatory submissions.

 

Minimum Required Skills: 

• B.S. in a Science field preferred

• Experience in Industry, preferably having 1-5 years of Clinical Research Associate experience in clinical trial administration or monitoring

• Proficient in Microsoft Office

• Exceptional teamwork, communication and organizational skills

 

How to Apply 

Send a cover letter describing relevant experience, resume, and three references by email to: admin@landrichgroup.com.  Indicate “Clinical Research Associate” in subject line.  References will not be contacted without permission from the applicant.  Applications will be accepted until position is filled.  Please no calls.  Visit website for more information:  www.landrichgroup.com