Department: Administration Designation: Manager

Experience: Minimum 8 years Qualification: Post graduation

Supervisory Responsibilities: Yes Location: NH Units

About NH:

Narayana Health is headquartered in Bengaluru, India, and operates a network of hospitals in India
and Overseas. Our mission is to deliver high quality, affordable healthcare services to the broader
population.
For more details please refer to our website at: https://www.narayanahealth.org.

Job Purpose

Oversee the conduct of Oncology Collegium’s activities and assigned clinical studies including acting as
liaison to clinical investigators, ensuring the quality and integrity of data. He / she will be the primary
contact person with the investigator, sponsor/CRO/university/governmental agency. Will be
responsible for the day to day conduct of the study as per prescribed and updated protocol. Ensure the
conducted of the study is in accordance with the regulatory and ethical guidelines following good
clinical research practice (GCP).

Job Responsibilities

a. Direct Responsibilities
• Coordinate Onco Collegium’s activities in the hospital and provide periodic status reports
• Be trained and aware of Good Clinical Practice Guidelines as prescribed by the Indian
Council for Medical Research
• Ensures that all clinical activities are carried out in accordance with established research
protocol and standards and in compliance with all applicable laws, regulations, policies, and
procedural requirements as per Good Clinical Practice guidelines...
• Ensure completion of data retrieval, data entry and query resolution in a timely manner
• Oversees the planning, scheduling, and carrying out of day-to-day clinical activities and
procedures, ensuring efficient workflow and adequate care and treatment of research
subjects.
• Carry out efficient in-patient screening as specified in protocol and maintain a screening
log for all subjects potentially eligible for the study protocol
• Complete entry in the prescribed case report forms and collect all necessary source
documents to support the data entry.
• Schedules study subject appointments and serves as the patient liaison to the PI and other
participating physicians

ADM/ADMINISTRATION/CHIEF OPERATING OFFICER/L11/2019/JAN

 • Coordinates and attends sponsor Site Selection visits, Routine monitoring visits, and study
close out visits.
• Establishes and organizes study files, including but not limited to, regulatory binders, study
specific source documentation and other materials as required.
• Arranges secure storage of study documents that will be maintained according to
institutional policy or for the contracted length of time, whichever is longer.
• Performs miscellaneous and other administrative activities as assigned by the managers/
HOD
• Update knowledge through trainings, regulatory trainings, departmental trainings.
• Represent site at national and international meetings where necessary.
• Support similar efforts at other NH hospitals (travel necessary) as per requirement.

b. Responsibilities under supervision

• Coordinate the execution of Clinical Trial Agreement, contracts and budgets
• Assists the Principal Investigator in submission of study documents to applicable IRB/IEC
approval
• Ensuring accuracy, completeness, and timely submission of regulatory and other required
documents to the appropriate organizations or authorities (Ethics Committee, DCGI, HMSC,
ICMR)
• Assists in review of protocol, development of study materials including but not limited to, the
informed consent document, case report forms (CRFs), enrollment logs, and drug/device
accountability logs.
•

Candidate Requirements

Education: Bachelor’s Degree in Science / Allied Health Science

Experience: Minimum 8 years of experience in cancer treatment teams preferable, working under a
clinical research team and mandatory experience in computer skills and data entry.

Training requirements
• ICH-GCP Training
• Regulatory updates both National and international guidelines
• Protocol and eCRF Training
• Attend once a year training meeting for updates in project or skill development workshops

Knowledge & Skills Required:

• To be able to prioritize work.

• Attention to details
• Ability to gather data, compile information, and prepare reports.
• Knowledge of the principles and procedures of clinical research.
• Basic computer knowledge of MS office, word, excel
• Ability to communicate effectively, both orally and in writing.

ADM/ADMINISTRATION/CHIEF OPERATING OFFICER/L11/2019/JAN