Clinical Research Associate (CRA)

Company: PAREXEL International Corporation Job Category: Pharmaceutical/ Biotechnology Experience: 1 - years Location: Manila

Job Description: 1. Participate in the identification and selection of potential investigators to ensure that the sites have adequate time and can fulfill their obligations to the study. 2. Assist in the preparation of, or support those involved in regulatory and ethics committee/IRB submissions and in the generation of Financial Agreements according to standard and local country practices. Ensure that documents are collected in a timely manner in order to meet regulatory and ethics committee/IRB submission dates. 3. Initiate investigational sites to ensure that they have a thorough understanding of the clinical protocol and the requirements of the study, and that they can fulfill their obligations to conduct the study accurately and to deadlines. 4. Perform site visits to ensure that the site personnel are conducting the study in accordance with the protocol and ensure that any issues arising from the visit are documented in a visit report and addressed with the site in a timely manner. 5. Ensure that the principal investigator complies with the serious adverse event reporting requirements as defined by both the client and regulatory authorities within the specified time periods. 6. Prepare and submit visit reports in a timely manner (per PAREXEL SOPs or contract as appropriate). 7. Complete routine administrative tasks in a timely manner (e.g., timesheets, metrics, travel expense claims). 8. Perform ongoing on site data management/collection to ensure that any issues relating to the quality of the data are communicated to the site personnel in a timely manner and maintain close contact with Data Management. 9. Maintain project tracking system on an ongoing basis to ensure that progress regarding the sites can be tracked and reported to the Project Manager as required. 10. Assist with the preparation and presentation at investigator meetings, as required to ensure that the clinical and investigational site staff team are well informed about the study and related procedures. 11. Attend staff meetings and training sessions as required to complete the Training Modules in a timely manner. 12. Interact with investigators to obtain necessary documentation and information before, during and after the study. Ensure accurate inventory of central, investigator site and core files on an ongoing basis to ensure that the files are complete and can be used as a source of reference. 13. Assist with the audit of an investigational site or central files and liaise with Quality Assurance personnel as required to ensure that the study is being conducted in accordance with ICH GCP guidelines. Qualifications & Experiences: Good communication skill and proactive attitude. Ability to take initiative and work independently. A bachelor (or above) degree in a life science / Nursing/ Pharmacy/ Medical Sciences. Ability to speak and read the language(s) used locally in the country, plus a fluency in written and spoken English. Relevant work experience (e.g., CRA, CR Assistant, Study Coordinator, data management).