PSG Global Solutions
Clinical Research Monitor (CRA)
PSG Global Solutions, Minneapolis, Minnesota, United States, 55400
DescriptionWe're looking for a
Clinical Research Monitor(CRA) , working in
Healthcare Systems
and
Services
industry in
Minneapolis, Minnesota, United States .
Job description:
Monitors progress of clinical trials at the site level or headquarters and ensures that they are conducted, recorded and reported in accordance with the protocol, standard operating procedures (SOP), good clinical practices (GCP), and other applicable regulatory requirements.Develops and maintains liaison with clinical investigators, clinical research organizations (CRO), affiliated hospitals, and research institutions to initiate and expedite clinical studies on products that have investigational new drug or medical devices approval.Responsible for reviewing adverse event cases with investigators, determining and monitoring time, budget, schedules, preparing study documents, and issuing status reports.May assist with design, development, and monitoring of clinical evaluation projects.Trains investigators and site personnel.Includes headquarter and field clinical research associates (CRA).Implements and prepares the clinical development strategy as outlined by the clinical teams.May contact and recommend qualified investigators to perform studies and initiate clinical trials.Ensures recruitment and retention of patients.Plans, executes and validates the centralized Risk-Based Monitoring processes for assigned programs in conformance with relevant regulations, guidelines, policies and procedures with general oversight.Conduct centralized monitoring activities across the various phases of the trial associated with the study planning, start-up, execution, closeout, of clinical trials utilizing OC-RDC and CTMS (and additional electronic platforms as needed).Provide input into the integrated centralized Risk-Based Monitoring plans, monitoring guidelines, and source data verification plans.Compile historical site performance metrics and trending analysis.Maintain oversight of key operational risk indicators (trial and site level); investigate and mitigate potential trial risks.
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Clinical Research Monitor(CRA) , working in
Healthcare Systems
and
Services
industry in
Minneapolis, Minnesota, United States .
Job description:
Monitors progress of clinical trials at the site level or headquarters and ensures that they are conducted, recorded and reported in accordance with the protocol, standard operating procedures (SOP), good clinical practices (GCP), and other applicable regulatory requirements.Develops and maintains liaison with clinical investigators, clinical research organizations (CRO), affiliated hospitals, and research institutions to initiate and expedite clinical studies on products that have investigational new drug or medical devices approval.Responsible for reviewing adverse event cases with investigators, determining and monitoring time, budget, schedules, preparing study documents, and issuing status reports.May assist with design, development, and monitoring of clinical evaluation projects.Trains investigators and site personnel.Includes headquarter and field clinical research associates (CRA).Implements and prepares the clinical development strategy as outlined by the clinical teams.May contact and recommend qualified investigators to perform studies and initiate clinical trials.Ensures recruitment and retention of patients.Plans, executes and validates the centralized Risk-Based Monitoring processes for assigned programs in conformance with relevant regulations, guidelines, policies and procedures with general oversight.Conduct centralized monitoring activities across the various phases of the trial associated with the study planning, start-up, execution, closeout, of clinical trials utilizing OC-RDC and CTMS (and additional electronic platforms as needed).Provide input into the integrated centralized Risk-Based Monitoring plans, monitoring guidelines, and source data verification plans.Compile historical site performance metrics and trending analysis.Maintain oversight of key operational risk indicators (trial and site level); investigate and mitigate potential trial risks.
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