Job Description
• Obtains and maintains confidentiality of proprietary information belonging to Samahitha as well as to the Sponsors, Investigator Sites & Third Parties with which Samahitha contract
• Management and oversight of subcontractor activities in the assigned trial (represents the principle contact from Samahitha for subcontractors like Clinical Laboratories, Translation Agencies, CRF, and other documents Printing Agencies, etc.)
• Development or customization of study documents (Study Management Plan and/or Monitoring Plan, Informed Consent, IMP Labels, Study Guidelines, Trial Specific Standard Forms, etc.) in consultation with PM and the Sponsor
• Management of translations for the assigned trials
• Management of the regulatory activities for the assigned clinical trial (compiles submission package that is sent to sites, verifies for accuracy and completeness of the documents that are submitted, informs Project Manager / Designee about all new / updates study documents that become available, informs CRAs and CTAs each time a new approval is obtained
• Plans investigator meetings and represents Samahitha during those meetings
• Adverse event reporting during the assigned clinical trial
• Management of clinical trial supplies (provides information regarding clinical drug supplies requirement for a particular trial (Quantity and Storage), and helps Depot Coordinator (Subcontractor) in arranging the infrastructure to meet those storage requirements; overall accountability of drugs sent/receipt to/from the sites, managed by his/her team of CRAs, maintains evidence of all CRF and other study materials received at Samahitha).
• Development and maintenance of the Trial Master File (administration of all study and center related documents before and during the course of the study -i.e., drug accounting documents, correspondence, review the monitoring reports, contact reports and other organizational documents)
• Management of the site initiation visits, routine monitoring visits and site closure visits (planning, obtaining greenlight from Quality Assurance Manager / Designee, review of monitoring reports).
• Coordinates and supports all CRAs and CTAs involved in the assigned clinical trial. Generates databases for appropriate study administration and administer all required study data to database;
• Provides Sponsor or Samahitha Management Team with information on enrollment, local study management, if and when required and compiles and archives study progress documentation.
• Management of Data Clarification Flow
• Prepares co-monitoring visits plan and conducts co-monitoring visits, if required.
• Updates the investigators and team members’ information – newsletters, phone conference, etc.)
Designation: Clinical Research Coordinator (CRC)
Years of Experience: 0 to 1 Year Experience in Clinical Research
Looking for immediate Joiner
