About the role
JOB DESCRIPTION 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 <Unit Name> LOCATION DETAILS Please mention the correct office location of the Role selected above and fill in the other geographic details Base Location (City) <Unit Location> 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(Good 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