Skip to main content

Vacancy for Clinical Research Coordinator in Fortis Hospitals

 

Clinical courses

Fortis Hospitals, Bangalore, Kolkata, Kalyan, Kolkata is India's leading Hospital Chain with 10 Hospitals across India with a number of super specialty hospitals at Mumbai, Bangalore, and Kolkata. With the latest technology, multi-disciplinary capability, state of the art facilities, world class infrastructure and excellent patient care ambiance and processes, Fortis Hospitals is poised to become the most advanced and progressive health care institution in this part of the world.

Post: Clinical Research Coordinator

No. of Post: 01

CRC provide coordination support to consultant, CRO Pharma companies for the smooth and ethical conduct of clinical trial. The job involves facilitation and coordination to ensure smooth conductance of trial.

Job Description:

  • Facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study.
  • Schedules study participant appointments and serves as the patient liaison to the PI and other participating physicians.
  • Reviews and comprehends each assigned protocol including study proceedings and timelines, inclusion and exclusion criteria, confidentiality and privacy protections.
  • Working closely with the PI, participates in an integral way in the informed consent process by communicating clearly and openly with potential study patients about protocols open to enrollment. Possesses a thorough knowledge of the informed consent process as well as a thorough understanding of the study protocol(s) in order to be able to answer all questions pertaining to the study posed during the informed consent process.
  • Develops clinical study budgets based on proposed study protocols.
  • Coordinates approval of new study agreements and contracts.
  • Coordinates and attends sponsor prequalification visits, monitor visits, study termination visits.
  • Completes case report forms. Extracts data from patient charts in a timely manner
  • 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 department to help ensure that clinical research and related activities are performed in accordance with Federal regulations, BFS and sponsoring agency policies and procedures.
  • Assists the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to (but not limited to) protocol requirements, schedule of visits, execution of research plan. Maintains records and other documentation of training.
  • Maintains subject screening logs and protocol deviation logs.
  • Maintains a spreadsheet tracking updates to database of all subjects enrolled on clinical trials.
  • Coordinates and facilitates monitoring and auditing visits. Notifies appropriate institutional officials of external audits by, Regulatory agencies, CROs and sponsors.
  • Collaborates with PI and institution to respond to any audit findings and implement-approved 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.
  • Ensures that all materials for each clinical trial protocol are available for subject enrolment.
  • Works collaboratively with the other members of the clinical research team and the clinical and administrative support teams to ensure all protocols are followed and that there is timely documentation and submission of study data.

 

  • Assists with study materials including but not limited to, the informed consent document, case report forms (CRFs), enrollment logs, and drug accountability logs.
  • Establishes and organizes study files, including but not limited to, regulatory binders, study specific source documentation and other materials as required.
  • Assists the Principal Investigator in submission of accurate and timely closeout documents.
  • To coordinate with consultant for new research feasibilities, approval of projects from ethics committee.
  • To coordinate with sponsor for monitoring visit required to be done at site , assisting the monitor in qualification visit including explaining the infrastructure and facilities for the trial. To ensure timely approval of DNB thesis of students.

Find more info on Next Page...

Subscribe to Pharmatutor Job Alerts by Email

Candidate Profile:
B.Pharma//BDS+ Post graduation diploma in advance clinical research  Experience: 0 - 3 years

Additional Information:
Experience: 0-3 years
Education: B.Pharma//BDS
Location: Mumbai
Industry Type: Medical / Healthcare / Hospitals
Functional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology

APPLY THROUGH RECRUITERS PORTAL>>

See All   B.Pharm Alerts   D.Pharm Alerts   Mumbai Alerts

See All   Other Jobs  in our Database

PharmaTutor Placements

Subscribe to Pharmatutor Job Alerts by Email