- Clinical Research Associate (CRA)
- Clinical Monitor
- Trial Monitor
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.
- 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
- Clinical Research Contract Organizations