B Pharma Project Coordinator Post Available @ Intas
B Pharma jobs. Pharma jobs. Intas hiring candidates with a bachelors degree in Pharmacy.Project Coordinator Post vacant @ Intas.Intas 2019 Jobs, Intas Project Coordinator jobs, Pharmaceutical Science jobs 2019. Intas hiring B Pharma candidates for a Project Coordinator Post. Interested and eligible candidate can Apply for this post.Check out all the details about the job below:
Job Title: Project Coordinator
Work Location: Ahmedabad
Eligibility: UG -B.Pharma – Pharmacy
Salary: INR 3,00,000 – 5,00,000 P.A.
Job Description:
- Ensure project coordination and conduct as per protocol and SOPs
- Work in close coordination with the Principal Investigator and Head-CPMA
Pre-study: - Review and finalization of protocol, ICF, CRF and other appendices (applicable in case of special studies)
- Communicate with sponsor on all projects related issues.
- Distribute protocol and related documents.
- Handle project related IP and its documentation (IP retrieval, verification, accountability, dispensing etc).
- Issuance of SOP related forms
- Prepare labels and Binders (binder, files, dispensing labels etc).
- Verification of Randomization schedule
- Train the study personnel on project related activities and hand over relevant documents to concerned person.
- Ensure arrangement of staff and other study related activities.
- Ensure proper initiation and conduct of the trial.
- Communicate with sponsors, other departments and team on appropriate aspects of the clinical studies
- Ensure proper documentation of Adverse Drug Reactions, Note to files, Deviations etc.
- Reporting of SAEs as per regulatory requirements
- Accountability of ICF and Criteria checks
- Check all forms including consent forms.
- Ensure arrangement for activities like, ambulatory, precheck-in visits, post study and co-ordination of the same.
- Co-ordinate QA audits of corrected forms.
- Ensure subject contact during the washout period and follow-ups
Key Skills:
- Handle subject compensation.
- Check all the forms
- Generate protocol deviations
- Send clinical updates to all concerned.
- Send communications of discontinued subjects, BA details to concern.
Others:
Take part in the day-to-day clinic activities
Help maintain and update all the systems and SOPs in the department
Train the staff on the entire Project related aspects and related SOPs & giving inputs for developing systems.
