Clinical Research

Job Title

  • Clinical Research Associate (CRA)
  • Clinical Monitor
  • Trial Monitor

Educational Background

  • B.Sc.

Job Functions

Clinical trial associate (CRA) participate in setting up and monitoring the different phases of clinical trials of drugs. CRA conducts pre-study, study initiation, routine monitoring and close out visits to the clinical trial site.

Job Responsibilities

  • Write clinical trial protocols.
  • Visit various clinical trail sites, evaluate the sites and identify potential sites and brief appropriate trial investigators the clinical trial protocol.
  • Establish a clinical trial site and initiate and monitor the trial and close the site down once the clinical trial is completed.
  • Maintain appropriate documentation as needed
  • Visit the trial site regularly to monitor and then write visit reports.
  • Support the development of subject recruitment plans.
  • Responsible for recruiting of study participants, obtaining informed consent, protecting subject confidentiality and updating subject information.
  • Consult with the appropriate committee/ department regarding rights, safety and well being of trial subjects
  • Train the site staff on any study related training such as on the therapeutic area, protocol requirements, case report form completion, sponsor policy and procedures, investigator responsibilities
  • Administer the study protocol to the assigned sites and verify the drug product has been dispensed and administered according to the protocol.
  • Evaluate the quality and integrity of site practices and take appropriate actions towards any quality issues and escalate the issue if needed.
  • Responsible for sourcing and managing the required trial materials and drug products.
  • Comply with company’s standard operating procedures (SOPs) and regulations and guidelines.

Must Have Skills

  • Strong communication (verbal and written) and interpersonal skills.
  • Knowledge of applicable clinical research regulatory requirement
  • Familiarity with required medical terms
  • Able to follow regulations and guidelines, work independently and with accuracy, set priorities and think critically.
  • Must be comfortable traveling regularly
  • Committed to well being of subjects, customer service and team work

Type of Companies that hire

  • Pharmaceutical
  • Biopharmaceutical
  • Biotech
  • Clinical Research Contract Organizations

Competitive Advantage

Career Growth

Recommended Readings