Opportunity for B.sc/ M.sc Clinical Research Candidate to Work as Safety officer @ Theorem Clinical Research
In our industry, the work is dynamic and complex, which provides an opportunity for some to succeed where others cannot. In short, we see the challenge of complex research as the reward. Being part of the best research team is only possible with a culture that champions forward thinking and people who are passionate about what they do at every level. That’s exactly what you’ll find at Theorem. At Theorem, you’ll work on cutting-edge global research projects in a fast-paced, collegial atmosphere where you’ll make meaningful contributions and be rewarded for them. There’s abundant room for advancement at Theorem, along with generous incentive programs. We’re always thinking — thinking of better ways to conduct research and how to deliver new capabilities into advantages for our clients. If you’re passionate about the same things, Theorem is where you belong.
Job Title: Safety officer
Job Description:
Develops study−specific safety monitoring plans, documents, and tools to ensure the consistent and timely reporting of SAEs
Interacts and communicates with clients when appropriate and under supervision.
Reviews Clinical Trial Protocols, Case Report Forms and Adverse Event Reporting forms for assigned projects.
Receives and acknowledges receipt of reports, reviews adverse events for completeness and accuracy, triages reports, sets up case files and assigns local reference numbers.
Prioritizes cases for processing and prepares initial evaluation for seriousness, expectedness and causality in order to assess regulatory status for expedited reporting under § 21 CFR 312.32 and 314.80.
Processes and reports spontaneous and clinical adverse events according to Standard Operating Procedures (SOPs), and Company/Client Conventions.
Identifies all relevant patient records and information pertaining to adverse experiences. Ensures adequate information is received for each case. Conducts appropriate follow−up to ensure collection of adequate clinical information, and contacts reporters directly ifrequired. Maintains source documents and safety−related documentation electronically and physically.
Enters required case data (including medical history, laboratory tests results, and risk factors) into the safety database as per applicable SOPs, regulatory guidelines and working practices. Prepares/writes comprehensive narrative case summaries of reportable events, and entering narrative into Safety Database. Appropriately codes adverse events using the MedDRA dictionary.
Prepares and generates 7−Day Alerts and 15−Day Individual Case Safety Report submissions. Provides expeditable serious adverse event reports and endpoints to clients, regulatory authorities, ethics committees, investigators and Clinimetrics/Company project personnel, if required, within project specified timelines. Provides independent QC of adverse event reports for other members of the group.
Provides safety letters as required for specific clinical projects including analysis of similar events.
Generates and reviews individual adverse event reports, adverse event tabulations and data summaries, and prepares/writes periodic safety reports.
Performs database reconciliation and supports the maintenance of metrics and development of reports for the client.
Provides regular project status reports.
Provides all clients with a high quality of service in a cost−effective manner.
Assumes the role of the global coordinating safety officer in projects with up to 4 countries.
Qualification: B.sc/m.sc Clinical research
Experience: 1-2 years
Click here to apply directly
Click here and fill form to learn clinical research
In our industry, the work is dynamic and complex, which provides an opportunity for some to succeed where others cannot. In short, we see the challenge of complex research as the reward. Being part of the best research team is only possible with a culture that champions forward thinking and people who are passionate about what they do at every level. That’s exactly what you’ll find at Theorem. At Theorem, you’ll work on cutting-edge global research projects in a fast-paced, collegial atmosphere where you’ll make meaningful contributions and be rewarded for them. There’s abundant room for advancement at Theorem, along with generous incentive programs. We’re always thinking — thinking of better ways to conduct research and how to deliver new capabilities into advantages for our clients. If you’re passionate about the same things, Theorem is where you belong.
Job Title: Safety officer
Job Description:
Develops study−specific safety monitoring plans, documents, and tools to ensure the consistent and timely reporting of SAEs
Interacts and communicates with clients when appropriate and under supervision.
Reviews Clinical Trial Protocols, Case Report Forms and Adverse Event Reporting forms for assigned projects.
Receives and acknowledges receipt of reports, reviews adverse events for completeness and accuracy, triages reports, sets up case files and assigns local reference numbers.
Prioritizes cases for processing and prepares initial evaluation for seriousness, expectedness and causality in order to assess regulatory status for expedited reporting under § 21 CFR 312.32 and 314.80.
Processes and reports spontaneous and clinical adverse events according to Standard Operating Procedures (SOPs), and Company/Client Conventions.
Identifies all relevant patient records and information pertaining to adverse experiences. Ensures adequate information is received for each case. Conducts appropriate follow−up to ensure collection of adequate clinical information, and contacts reporters directly ifrequired. Maintains source documents and safety−related documentation electronically and physically.
Enters required case data (including medical history, laboratory tests results, and risk factors) into the safety database as per applicable SOPs, regulatory guidelines and working practices. Prepares/writes comprehensive narrative case summaries of reportable events, and entering narrative into Safety Database. Appropriately codes adverse events using the MedDRA dictionary.
Prepares and generates 7−Day Alerts and 15−Day Individual Case Safety Report submissions. Provides expeditable serious adverse event reports and endpoints to clients, regulatory authorities, ethics committees, investigators and Clinimetrics/Company project personnel, if required, within project specified timelines. Provides independent QC of adverse event reports for other members of the group.
Provides safety letters as required for specific clinical projects including analysis of similar events.
Generates and reviews individual adverse event reports, adverse event tabulations and data summaries, and prepares/writes periodic safety reports.
Performs database reconciliation and supports the maintenance of metrics and development of reports for the client.
Provides regular project status reports.
Provides all clients with a high quality of service in a cost−effective manner.
Assumes the role of the global coordinating safety officer in projects with up to 4 countries.
Qualification: B.sc/m.sc Clinical research
Experience: 1-2 years
Click here to apply directly
Click here and fill form to learn clinical research
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