Clinical Research Coordinator

2 weeks ago


Gandhinagar, Gujarat, India NovoBliss Research Pvt Ltd Full time

Job description

  • Facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study.
  • Responsible for coordinating the daytoday operations of clinical trials and studies.
  • Creates and/or maintains all documents and records related to the study
  • Acts as a point of reference for study participants by answering questions and keeping them informed on the study progress
  • Manages the inventory of equipments and supplies related to the study and orders more as needed.
  • Creates reports on each study, including notes on protocols, workload, data collection, and more
  • Coordinates and attends sponsor Site Selection visits, Routine monitoring visits, and study closeout visits.
  • Responds to data clarification requests in a timely manner.
  • May attend Investigator meetings requiring travel and report pertinent information back to research team members.
  • Coordinates with PIs and departments to help ensure that clinical research and related activities are performed in accordance with protocol, SOP, GCP and applicable regulatory requirement
  • Assists the PI in the development of materials and tools necessary to appropriately train individuals involved in the conduct of the study, like study protocol requirements, schedule of visits, execution of research plan. Maintains records and other documentation of training.
  • Collaborates with PI & institution to respond to any audit findings and implementapproved recommendations.
  • Completes documentation on each study visit that is used to track all study related activities so that time, effort and materials can be accounted for on a monthly basis.
  • Works collaboratively with the other members of the clinical research team and the clinical and administrative support teams to ensure protocols are followed and that there is timely documentation and submission of study data.
  • Assists with the development of study materials including but not limited to, the informed consent document, case report forms (CRFs), enrollment logs, and drug/device accountability logs.
  • Establishes and organizes study files, including but not limited to, trial master file (TMF), regulatory binders, study specific source documentation and other materials as required.
  • Assists the Principal Investigator in submission of accurate and timely closeout documents to applicable IRB/IEC and applicable regulatory requirement.
  • Arranges secure storage of study documents that will be maintained according to institutional policy or for the contracted length of time, whichever is longer.
  • Promotes the ethical conduct of research by reporting good faith suspicions of misconduct in research.
  • Responsible for ensuring study complies with local and national and international laws and regulations.
  • Any other tasks as assigned by the Management from time to time, upon the award of various studies
Industry
Research

Employment Type - Full Time

Salary:
From ₹12,000.00 per month

Benefits:

  • Provident Fund

Schedule:

  • Day shift

Supplemental pay types:

  • Overtime pay
  • Performance bonus

Ability to commute/relocate:

  • Gandhinagar, Gujarat: Reliably commute or planning to relocate before starting work (required)

Experience:

  • Clinical research: 1 year (required)
Expected Start Date: 14/02/2023

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