: Clinical Research Associate

  • Hysynth Technologies
  • Chennai, Tamil Nadu, India
  • Aug 23, 2016
Full time Paramedical

Job Description

ü  Candidate should posses excellent Communication Skills with pleasing personality.

ü  Candidates having prior experience will be preferred, though a fresh graduate can also appear for Interview.

ü  Completing supporting tasks assigned by the management within the provided time.

ü  Custodian Duties.

ü  Manage & monitor approximately 6 to 8 sites in multicentre clinical trial.

ü  Ensuring site level compliance & adherence to regulatory requirement protocol & SOPs.

ü  Coordinating with external vendors & internal team members for the smooth execution of the study

ü  Maintaining study level & site level regulatory & study documents

ü  Acting as a main point of contact between investigator & CRO to manage site level activities.

ü  Conduct Site selection / Lab selection for investigational site and laboratories.

ü  Participate and / conduct site meetings and multicenter investigator meetings and prepare reports.

ü  Setting up the study centers, by ensuring each centre has proper training of all participants, adequate materials and ensure that the investigator knows exactly what has to be done.

ü  Collate documents for Ethics committee submissions.

ü  Review on-site files and records, case report forms and source documents for completeness, accuracy, consistency and compliance, identifies deficiencies and discrepancies and provides remedial training and / or initiates corrective action as required.

ü  Verify that the investigator provides all the required reports, notifications, applications and submissions are timely, accurate, legible and complete and dated.

ü  Assemble necessary documents; conduct site closure / termination visits to include investigational product reconciliation and disposition, review for completeness and accuracy of files, retrieval of relevant codes and documents. Assess suitability of archival facility and prepare study termination reports.