BASIC INFORMATION

Position Title & Designation

Coordinator

JD Code

SHB/XXX/DEPT/NNN

Job Family

Clinical

Department

Clinical Research

ROLE DETAILS To be filled up as per the requirement of the Division / unit / function / territory

Grade

B1

Reporting To

Unit Head

Division

Corporate

Unit

LOCATION DETAILS

Please mention the correct office location of the Role selected above and fill in the other geographic details

Base Location (City)

Country

India

Job-Holder Specifications

QUALIFICATION

Basic Qualification / Education / Vocational Training

Graduate in any Bachelor of Pharmacy

Advanced

Qualification / Certification / Specialist Training

Post Graduation in Pharmacy or Clinical Research

EXPERIENCE

Minimum Experience

0 – 3 Years

Specific /relevant experience

0 – 3 Years

COMPETENCIES

Functional Skills and Capabilities

Behavioural

- Strictly procedure oriented
- Responsible in nature
- Professional Approach
- Reliable and trustworthy
- Effective Communication
- Interpersonal Skills
- Planning ability

Functional

- Knowledge about various research Schedules
- Knowledge about regulatory guidelines like ICH(International Council for Harmonization), GCP(Positive Clinical Practices)
- Knowledge of protocol compliances
- Well acquainted with clinical study procedures

Objective To work in coordination with Principal Investigator, sponsor, CRO, Ethics Committee, Institution to implement and coordinate on the clinical study related activities in accordance with Schedule Y, ICH and GCP regulatory guidelines.

Key Responsibilities

1

Clinical Study Procedures

- Communicate with PI, assist for IP, non IP and concomitant medication
- Take regular on-site and telephonic follow up for protocol compliance,



IP compliance and adverse event
- Assisting patients in completing health assessment questionnaire
- Assisting during visit and audit, resolving queries generated by data management department
- Preparation of EC submission for protocol approval
- Timely EC notification for Serious Adverse Event (SAE), protocol deviation, (Suspected Unexpected Serious Adverse Reaction (SUSAR) notification and others
- Provide required study and subject documents at the time of SAE to EC
- Screening of subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participants eligibility or exclusion
- Register participants to the appropriate coordinating center(by IVRS or IWRS) and register in hospital database
- Review and implement the protocol i.e. study procedures, timeliness, inclusion and exclusion criteria, confidentiality etc
- Preparing source documents as per protocol like ICF, checklist, case report forms, enrollment logs, drug accountability logs, EC notification etc
- Establishes and organizes study files including patient file, SMF, EC and regulatory notification, study specific source documentation and other materials
- Collection of data as per requirement of the protocol
- Assure timely completion of case report forms and query resolution
- Maintain timeliness of study




- Maintain adequate inventory of study supplies and its accountability, proper storage, handling, temperature recording
- In case of SAE, prepare Appendix XI and SAE form and sending it to DCGI, sponsor, EC and Institute within timeline

2

Informed Consent Form (ICF)

- Participate in the informed consent process(ICF) including interactions and discussions with research participants, answering to their queries
- Obtaining appropriate signatures and dates on ICF

3

Coordination

- Coordinate with Principle Investigator(PI) in audio and video consenting procedure, with inclusion exclusion criteria assessment, screening procedure and routine scheduled visits
- Coordinating with different departments:

i)Laboratory Department: Blood Collection and processing ii)ER Department: Vitals, ECG etc

Iii)Biomedical Department: Calibration Certificate

Iv)Ortho Department: Joint count assessment

V)Radiology Department: X-ray CD and Report

- Assisting PI in communication of study requirements to all individuals involved in the study
- Coordinate with patient to schedule their visit and study related procedures like laboratory procedures, measuring vitals, ECG, X-Ray
- Collaborates with the PI to prepare Ethics Committee(EC) and any other regulatory submission documents as per the protocol requirement
- Coordinate with sponsor and Clinical Research Organization(CRO) for adverse event, raise invoice for due amount as per budget, required trial related documents, laboratory kits, IP and non IP supplies
- Coordinate participant tests and procedures
- Coordinate and facilitate monitoring and auditing visits

Employee Name

Ms. Snigdha Ray

Employee Signature

Received on (Date)

Version No: 001/ 2018-19

📌 Coordinator-Clinical Research (Indore)
🏢 SHALBY
📍 Indore