Hiring For Clinical Research Co-Ordinator @
- Vipany Management
- 1 to 2 Yrs
- Raipur, Nagpur
- 3 years ago
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Job Description
Dear Active Job seekers,
Greetings of the day,
We are looking for Clinical research coordinator
please find below job description
Roles and Responsibilities
- Identify new sites, PIs and conduct the detailed protocol specific feasibility.
- Preparation for site selection visit.
- IRB Submission & follow-up for Approval.
- Collection of Regulatory documents.
- Trial Master File (TMF) set up.
- Prepare site for Site Initiation Visit (SIV).
- Conduct study according to International Conference of Harmonization (ICH) E6 and Indian Good Clinical Practice (GCP) regulations.
- Assisting Principal Investigator in administering the Informed Consent Form process.
- Ensure protocol adherence and compliance.
- Pre-screening, screening, enrolling & recruiting patients.
- Creating and Preparing Source Documents and their templates.
- Coordinate and schedule subjects regular follow-up visits and procedures, preventing lost to follow-up & missed visits. Maintaining regular contact with patients telephonically.
- Manage Clinical Trial Materials (CTM), accountability, distribution & logistics at site.
- Co-ordinate all site specific queries-medical, administrative and others.
- Filling the case reports forms and electronic case report forms and resolving all data queries in time on Data Clarification Forms (DCFs).
- Maintain and update Trial Master File, site binders and relevant files.
- Reporting and coordinating all Adverse Events & Serious Adverse Events according to their timelines.
- Filling up and maintaining trial related logs like source documentation, drug dispensing logs, subject logs, Investigational Product Logs, temperature logs. Etc.
- Maintaining Calibration records.
- Preparing Site for Monitoring & Audit visits, Coordinate close out visit & Archival at site.
- Accurate and complete documentation of relevant EC documents.
- Communicating all protocol-related issues problems to the appropriate management staff including but not limited to questions regarding the conduct of trial, concerns regarding possible serious adverse events or subject compliance.
- To document protocol deviations as appropriate and communicate any impacting subject safety to the Ethics Committee.
- Coordinate Central Lab logistics & sample flow, Review Lab data & Communicate abnormal values to the primary care provider (if appropriate) & Investigator.
Desired Candidate Profile
Experience: 1-2 yrs
Qualification: BAMS, BHMS, Post-graduate in life science with Clinical Research Degree/Diploma, B. Pharm, M.Pharm, BSc in Life Science.
Interested candidates kindly share your resume at di*****g@vi********p.com
Regards,
Dileep
Associate Team Lead-Talent Acquisition
dileep.gvipanygroup.com
Vipany Management Consulting Pvt Ltd.
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Employement Category:
Employement Type: Full timeIndustry: IT - Software
Role Category: General / Other Software
Functional Area: Not Applicable
Role/Responsibilies: Hiring For Clinical Research Co-Ordinator @
Contact Details:
Company: Vipany ManagementLocation(s): Raipur, Nagpur
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₹ 1.0 - 2.5 Lakh/Yr
Vipany Management
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