Job Description
Prepares/Reviews protocol prior to IRB review for correctness, compliance, subject safety and feasibility of study design Coordinates protocol review process with all applicable reviewers and makes updates to protocol as required
Responsible for all activities related to the protocol management including the coordination of the Informed consent translations, protocol status reports, preparing protocols for IRB meetings
Ensures all regulatory documents are completed for the applicable jurisdictions
Responsible for general inquiries from volunteer/subjects
Activates approved Protocol for study use and distribution after IRB approval and applicable sign off
Prepares screening and study documentation for data collection
Ensures that recruitment targets meet protocol study requirements
Coordinates with booking volunteers for registration, screening activities and follow-up appointments as required
Reviews the completed Screening documentation for inclusion and exclusion criteria dictated by project-specific protocols.
Conducts protocol training with all staff involved in the screening/study activities.
Ensures adequate quantity of materials and supplies are available before initiation of the study.
Oversees in the TA license procedure, receipt, dispensation and inventory of test materials
Log out of test articles and assigns applicable Nurse/Staff to distribute to subjects
Directly supervises and takes delegated responsibility for the conduct and safety of volunteers participating in clinic trials, for adherence to protocols and regulatory requirements
Monitors clinic staff activities for compliance with protocol and SOPs
Collects, reviews and summarizes clinical data, reports, and compiles the clinical portion of the report
Oversees the sample transfer process
Ensures projects meet the projected timelines and communicates updates
Assists in the creation, development and revision of the Bioequivalence Centres Clinical Operations Department Standard Operating Procedures.
Executes other duties as may be assigned by the Clinical Operations Management/delegate as training and experience allow.
Salary: Best In The Indsutry
Industry: Pharma / Biotech / Clinical Research
Functional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology
Role Category: Clinical Researcher
Role: Clinical Researcher
Keyskills: Clinical Operations, Protocol Preparation, Clinical Monitoring Clinical Sudies, Clinical Sudies, Clinical Trials, Clinical Monitoring
Responsible for all activities related to the protocol management including the coordination of the Informed consent translations, protocol status reports, preparing protocols for IRB meetings
Ensures all regulatory documents are completed for the applicable jurisdictions
Responsible for general inquiries from volunteer/subjects
Activates approved Protocol for study use and distribution after IRB approval and applicable sign off
Prepares screening and study documentation for data collection
Ensures that recruitment targets meet protocol study requirements
Coordinates with booking volunteers for registration, screening activities and follow-up appointments as required
Reviews the completed Screening documentation for inclusion and exclusion criteria dictated by project-specific protocols.
Conducts protocol training with all staff involved in the screening/study activities.
Ensures adequate quantity of materials and supplies are available before initiation of the study.
Oversees in the TA license procedure, receipt, dispensation and inventory of test materials
Log out of test articles and assigns applicable Nurse/Staff to distribute to subjects
Directly supervises and takes delegated responsibility for the conduct and safety of volunteers participating in clinic trials, for adherence to protocols and regulatory requirements
Monitors clinic staff activities for compliance with protocol and SOPs
Collects, reviews and summarizes clinical data, reports, and compiles the clinical portion of the report
Oversees the sample transfer process
Ensures projects meet the projected timelines and communicates updates
Assists in the creation, development and revision of the Bioequivalence Centres Clinical Operations Department Standard Operating Procedures.
Executes other duties as may be assigned by the Clinical Operations Management/delegate as training and experience allow.
Salary: Best In The Indsutry
Industry: Pharma / Biotech / Clinical Research
Functional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology
Role Category: Clinical Researcher
Role: Clinical Researcher
Keyskills: Clinical Operations, Protocol Preparation, Clinical Monitoring Clinical Sudies, Clinical Sudies, Clinical Trials, Clinical Monitoring
Desired Profile
Qualified M. Pharm candidate is Preferred.Should have 3-7 years experience experience in clinical operations and management.
Should be good in written and verbal communication skills.
Well versed with regulatory guidelines.
Should be good in documentation.
Education:UG -B.Pharma - Pharmacy
PG - M.Pharma - Pharmacy
Doctorate - Doctorate Not Required
Should be good in written and verbal communication skills.
Well versed with regulatory guidelines.
Should be good in documentation.
Education:UG -B.Pharma - Pharmacy
PG - M.Pharma - Pharmacy
Doctorate - Doctorate Not Required
Company Profile
Apotex Inc., founded in 1974, is the largest Canadian-owned pharmaceutical company. We employ over 6,000 people worldwide in research, development, manufacturing and distribution. We produce more than 300 generic pharmaceuticals in approximately 4000 dosages and formats and export to over 115 countries around the globe. APOTEX RESEARCH PRIVATE LIMITED (ARPL) based at Bangalore is a 100% owned subsidiary of Apotex Inc., and is engaged in the development, bio-clinical evaluation, manufacturing and distribution of safe and efficacious generic pharmaceutical formulations for the global market. As a part of this dynamic team, you will get to work in our state-of-the-art facilities, which include sophisticated equipments", high standard processes and the opportunity to work alongside some of the world's top professionals. Apotex encourages the new technological developments in the field of research, manufaturing and distribution and embraces all the new techniques and technologies available in our area of concentration, our new manufaturing facility has been inaugurated in June 2012 and uses some of the most sophisticated technologies and machines available today.
Subscribe to us
100% Free.
Get It
close
No comments:
Post a Comment