Clinical Research Associate

Highly Competitive Salary
  1. Permanent
  2. Clinical Trial Assistant (CTA), Clinical Research Associate (CRA), Clinical Scientist
  3. United States
Durham, USA
Posting date: 27 May 2021
CR.JZ.37829A

Proclinical is recruiting for a remote based Clinical Research Associate for a leading pharmaceutical company. As the CRA, you will assist the Clinical Trial Managers with achieving key study parameters including, but not limited to, clinical study start-up activities, study execution, data collection, and close-out.

Job Responsibilities:

  • Perform qualification, initiation, interim, and close out visits in accordance with established SOPs.
  • Complete monitoring visits and submit visit reports in accordance with Clinical Monitoring Plan.
  • Perform Protocol and Study related training.
  • Accountable for the collection of documents for, and maintenance of, the electronic Trial Master Files (TMF) in accordance with SOPs
  • Performs ongoing reviews of TMF to assure quality of the documentation files and compliance with SOPs, GCP and ICH Guidelines.
  • Manage site and study progress by tracking IRB submissions, regulatory documents, start-up activities, enrollment, CRF completion, and query resolution.
  • Attends Investigator Meetings and study-specific training for assigned trials.
  • Develops and maintains collaborative working relationships with clinical investigative sites.
  • Conduct meetings with the Investigator and Study Coordinator at each site visit and with other key staff, as needed.
  • Communicate with the investigator and site staff as necessary to address questions, issues, or provide information.
  • Complete IP accountability reviews and ensure that IP is stored and dispensed properly.
  • Identify, analyze, and report serious compliance issues and develops action plan for approval.
  • Perform Source Data Verification per Clinical Monitoring Plan.
  • Understands assigned protocol(s) and trial specific manuals/plans to ensure quality and deliverables are met across assigned sites.
  • Assist the Clinical Trial Managers with development of study plans, informed consent documents, case report forms (CRFs), site source documentation, etc.
  • Perform co-monitoring visits with contract CRAs to ensure quality of monitoring; provide training and guidance as needed.
  • Other tasks and responsibilities as needed.

Skills and Requirements:

  • At least 1-2 years of independent monitoring experience
  • Open to CRO or Sponsor Pharmaceutical backgrounds
  • National Travel- 60% in peak periods, with an average of 30-40%
  • Therapeutic area: Pain Management (non-opioid)

If you are having difficulty in applying or if you have any questions, please contact Jax Zafrani at (+1) 213-893-4997 or j.zafrani@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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