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clinical research associate

  • Responsible for the detailed processes of recruitment, including consenting, application of medical device, and collection of data.
  •  Ensure integration of device  with EEG, other respiratory, cardiac and additional biological data collected during in-patient period and to make data set available to research team.
  •  Enter data into relevant databases and prepare cohorts for in-house studies.
  •  Undertake statistical analysis of data. 
  • Maintain accurate and complete records and ensure data security and confidentiality of medical data. 
  • Ensure the highest standard of record keeping, maintaining 

clinical research associate

  • Conduct research to develop methodologies, instrumentation, and procedures for medical application, analyzing data and presenting findings to the scientific audience and general public.
  • Write and publish articles in scientific journals.
  • Consult with and advise physicians, educators, researchers, and others regarding medical applications of physics, biology, and chemistry.
  • Teach principles of medicine and medical and laboratory procedures to physicians, residents, students, and technicians.
  • Design research studies in collaboration with physicians, life scientists, or other professionals.
  • Read current literature, attend meetings or conferences, and talk with colleagues to keep abreast of methodological or conceptual developments in fields such as biostatistics, pharmacology, life sciences, and social sciences.
  • Collaborate with others in the organization to ensure successful implementation of chosen problem solutions.

clinical research associate (oncology)

  • Ensured safe and right conduct of clinical trials according to ICH-GCP guidelines. Maintained understanding of PPD’s SOP (standard operating procedures) and also required PPD SOPs Provided clinical study progress reports to Clinical Trial Manager periodically. 
  • Planned & conducted pre-study site evaluation visits with Sr. Clinical Research Associates / Clinical Trial Monitor. Conducted clinical site feasibility and also help CTMs in study feasibility. Prepared and maintained Clinical Study Files including Trial master files (TMF), Investigator Site File (ISF), Investigator File (IF), study essential documents and regulatory documents.
  • Prepared EC (Ethical committee) document for submission and other tools, templates and documents before clinical site initiation. Attended and assisted with IM (investigator meeting) in presentations, training materials, logistic preparation, and coordination.
  • Planned & executed SIV (site initiation visit) with Sr. Clinical Research Associate/CTM. During site initiation visit (SIV) my responsibilities were meeting with clinical investigators (PI) and their teams to make sure that all aspects of the study were understood by the principal investigator and his/her staff, validated the suitability of the EC/IRB & to ensure that all records required for the study were completed.
  • Managed the clinical central laboratory in regard to issues of site. Planned, conducted site monitoring visits (SMV) as per study protocol under the supervision of the CTM/Designee. Closely kept track of patient recruitment procedure by contacting clinical sites & verify patient screening & enrollment development. Assessed the subjects (patients) for study protocol compliance though SDV (source data verification). Monitored patient Informed Consent progression for clinical study. Examined on-site CRFs (Case Report Forms) aligned with source documents for data authentication.
  • Identified discrepancies in the case report forms against the source documents occasionally, resolved them and after that took away the CRFs. Followed up with clinical site for resolution of DCFs or any queries. Ensured that adverse event/serious adverse event AE/SAE were reported and followed up with the concern departments. 
  • Assessed appropriate Investigational Product (IP) answerability at site. Planned and conducted site close out visits (SCV) and made sure that collection of all clinical study data was completed. Prepared the applicable site visit reports and follow up letters. Subsequent to study completion, ensured that investigational products (IP) of the study were returned to the PPD.

clinical research associate

  • Participating in the site selection process, feasibility assessment; 
  • Performing all types of study site monitoring visits;
  • CRF review and source data verification; 
  • Preparation for study submission to the regulatory authorities; 
  • Site management; visit reporting; 
  • S/AE processing, reporting and follow-up; 
  • Ensuring on-site compliance with national regulations, GCP, protocol and procedures; 

sr. clinical research associate

  • Conducting  pre-study, initiation, monitoring, and close-out visits according to SOPs and GCP;
  • Site management for assigned sites including written and verbal communication and scheduling of monitoring visits; 
  • Preparation of visit reports and maintenance of study-related databases;
  • Taking over Lead CRA responsibilities on a project, acting as the primary contact for all monitoring- related questions for the monitoring team;
  • Facilitating training for new CRAs.