Position: Clinical Research Associate
Job Responsibilties:
About Company:
Job Responsibilties:
Acts as a central point of communication between Sponsor and Investigators for all assigned clinical trial related activities to assure trials are conducted on time and budget while being compliant with ICH GCP, local regulatory requirements & Sponsor SOP requirements.
Participate in site nomination process; perform evaluation of site capability and make recommendation for inclusion in clinical trial
Facilitate preparation and collection of site level documents
Execute site initiation and training activities including site set up activities
Perform monitoring visits according to monitoring plan
Manage site drug supplies
Resolve site level update of technical systems (ClinAdmin, EDC, OC-RDC etc.)
Ensure site activities in line with milestones (i.e. startup, recruitment, closeout, etc.)
Manage recruitment implementing appropriate contingency plans as needed
Assure continual GCP, ICH and Novartis SOP compliance (Informed consent process, Source data verification, AE and SAE reporting, IN, protocol, drug accountability etc.). Resolve deviations to standard by remedial action and training
Author study monitoring reports
Perform data query resolution process (both at Site and with Data Management)
Execute site closeout activities
Acts as local (or global) CRA Lead, as assigned
Coordinate with the global clinical trial team and the CPO colleagues to ensure smooth conduct of the clinical study at the sites
Preparation of regulatory submission and liaising with the DRA team
Perform trial feasibilities
Assist in expanding investigator pool across different TAs
Perform budget negotiations if assigned and assist in TCF completion at different milestones.
Author SOPs if required
Participate in site nomination process; perform evaluation of site capability and make recommendation for inclusion in clinical trial
Facilitate preparation and collection of site level documents
Execute site initiation and training activities including site set up activities
Perform monitoring visits according to monitoring plan
Manage site drug supplies
Resolve site level update of technical systems (ClinAdmin, EDC, OC-RDC etc.)
Ensure site activities in line with milestones (i.e. startup, recruitment, closeout, etc.)
Manage recruitment implementing appropriate contingency plans as needed
Assure continual GCP, ICH and Novartis SOP compliance (Informed consent process, Source data verification, AE and SAE reporting, IN, protocol, drug accountability etc.). Resolve deviations to standard by remedial action and training
Author study monitoring reports
Perform data query resolution process (both at Site and with Data Management)
Execute site closeout activities
Acts as local (or global) CRA Lead, as assigned
Coordinate with the global clinical trial team and the CPO colleagues to ensure smooth conduct of the clinical study at the sites
Preparation of regulatory submission and liaising with the DRA team
Perform trial feasibilities
Assist in expanding investigator pool across different TAs
Perform budget negotiations if assigned and assist in TCF completion at different milestones.
Author SOPs if required
Desired profile for Job:
UG - B.Sc - Any Specialization, B.Pharma - Pharmacy
PG - Any Postgraduate - Any Specialization, Post Graduation Not Required, M.Sc - Any Specialization, M.Pharma - Pharmacy
Doctorate - Any Doctorate - Any Specialization, Doctorate Not Required
Doctorate - Any Doctorate - Any Specialization, Doctorate Not Required
Basic medical and business knowledge.
Desired at least 1-2 years experience in monitoring global clinical studies.
Understands and can apply knowledge of clinical trial designs to trial execution.
Knowledge and experience in international standards (GCP/ICH), international (FDA, EMEA) and local regulations.
Expertise in communication, managing clinical trials
Desired at least 1-2 years experience in monitoring global clinical studies.
Understands and can apply knowledge of clinical trial designs to trial execution.
Knowledge and experience in international standards (GCP/ICH), international (FDA, EMEA) and local regulations.
Expertise in communication, managing clinical trials
About Company:
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