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Planet Pharma
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Clinical System Support Specialist II
Abbott Park Green Oaks, IL 60044 US
Posted: 08/22/2024
2024-08-22
2024-09-29
Employment Type:
Contract
Job Category: Clinical Development and Operations
Job Number: 612995
Is job remote?: No
Country: United States
Job Description
To collect and submit objective evidence of the performance of our products, CRAs need to:
• lead small groups, interact well with teams yet also be independent contributors
•depending on experience, be able to help new CRAs onboard/train
•have good communication skills (oral/written/presentations) and be able to deal with conflicts and resolution (especially when representing the company externally)
•be able to take responsibility for a number of studies/sites and provide updates to Management (depending on their level of experience)
•understand i-STAT IVD products (cartridges/samples/analyzers)
•understand preanalytical sample handling issues and be able to run various cartridges then train others and answer questions (be comfortable with this in-person/remotely)
•support the creation of the protocol and all of the associated study documentation (brochures, ICFs, CRFs, IRB submission pkgs etc); important for training and trouble-shooting with sites
•identify and prequalify/approve sites where the studies will be carried out
•support the creation of study specific electronic data collection fields and system elements (additionally be able to do user acceptance testing)
•support the creation of the clinical trial master file folders and system elements
•work with sites to ensure all of the documentation from sites is collected prior to starting the study and is also filed
•support preparation and execution for study site initiations, collecting documents, generating training modules etc
•understand and be able to carry out data/site monitoring both remotely and onsite
•support data verification and reviews to prepare collected data for analyses
•lead and work with sites for close out of the studies
•lead and carry out post study tasks regarding reports, trial master file documents, financial documentation etc
•be very organized and comfortable carrying out clinical study tasks remotely and on-site (travel, US)
Exempt/Non Exempt: Non-exempt Years Experience: Typically requires 5+ years of relevent work experience or exposure to a technical / clinical environment, laboratory instrumentation and / or medical diagnostic testing to sufficiently demonstrate and fulfill the core job responsibilities of the position.
Skills: Knowledge of lab practices or point of care testing environments, regulations and standards affecting medical diagnostics, lab practices, familiarity with statistics and statistical software (desired).
Education: Bachelor's degree or equivalent experience required; prefer background in the sciences or a medically-related area (such as but not limited to Biology, Chemistry, Nursing, Medical Technology, Respiratory Therapy or related field of study).
Duties: Responsible for implementing the stategic initiatives established by the business and the department. Responsible for tactical components of creating and driving customer-centric relationships cross-functionally to support product developments throughout the product(s) life cycle. Subject matter expert (SME) in the technical application of product portfolio. Execution of all aspects of testing ncluding design, developing test materials, protocols, evaluation of test data, and all around support of analysis. Responsible for the execution of all aspects of clinical studies including but not limited to: site selection, pre-study visits, essential document review, site close-outs.
Travel up to 30% of the time domestically and / or internationally.
Pay ranges between $40-47/hr based on experience
• lead small groups, interact well with teams yet also be independent contributors
•depending on experience, be able to help new CRAs onboard/train
•have good communication skills (oral/written/presentations) and be able to deal with conflicts and resolution (especially when representing the company externally)
•be able to take responsibility for a number of studies/sites and provide updates to Management (depending on their level of experience)
•understand i-STAT IVD products (cartridges/samples/analyzers)
•understand preanalytical sample handling issues and be able to run various cartridges then train others and answer questions (be comfortable with this in-person/remotely)
•support the creation of the protocol and all of the associated study documentation (brochures, ICFs, CRFs, IRB submission pkgs etc); important for training and trouble-shooting with sites
•identify and prequalify/approve sites where the studies will be carried out
•support the creation of study specific electronic data collection fields and system elements (additionally be able to do user acceptance testing)
•support the creation of the clinical trial master file folders and system elements
•work with sites to ensure all of the documentation from sites is collected prior to starting the study and is also filed
•support preparation and execution for study site initiations, collecting documents, generating training modules etc
•understand and be able to carry out data/site monitoring both remotely and onsite
•support data verification and reviews to prepare collected data for analyses
•lead and work with sites for close out of the studies
•lead and carry out post study tasks regarding reports, trial master file documents, financial documentation etc
•be very organized and comfortable carrying out clinical study tasks remotely and on-site (travel, US)
Exempt/Non Exempt: Non-exempt Years Experience: Typically requires 5+ years of relevent work experience or exposure to a technical / clinical environment, laboratory instrumentation and / or medical diagnostic testing to sufficiently demonstrate and fulfill the core job responsibilities of the position.
Skills: Knowledge of lab practices or point of care testing environments, regulations and standards affecting medical diagnostics, lab practices, familiarity with statistics and statistical software (desired).
Education: Bachelor's degree or equivalent experience required; prefer background in the sciences or a medically-related area (such as but not limited to Biology, Chemistry, Nursing, Medical Technology, Respiratory Therapy or related field of study).
Duties: Responsible for implementing the stategic initiatives established by the business and the department. Responsible for tactical components of creating and driving customer-centric relationships cross-functionally to support product developments throughout the product(s) life cycle. Subject matter expert (SME) in the technical application of product portfolio. Execution of all aspects of testing ncluding design, developing test materials, protocols, evaluation of test data, and all around support of analysis. Responsible for the execution of all aspects of clinical studies including but not limited to: site selection, pre-study visits, essential document review, site close-outs.
Travel up to 30% of the time domestically and / or internationally.
Pay ranges between $40-47/hr based on experience
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Discover exciting job opportunities in the vibrant area of Green Oaks, Illinois! Situated in the picturesque Lake County, just a stone’s throw away from Chicago, Green Oaks offers a perfect blend of suburban tranquility and urban convenience. With renowned art galleries, such as the David Adler Music and Arts Center, thriving theater scene including the Citadel Theatre Company, and beautiful green spaces like Independence Grove Forest Preserve, this region is a haven for both outdoor enthusiasts and culture aficionados. Enjoy easy access to professional sports teams like the Chicago Bears and Cubs, as well as delectable cuisine ranging from authentic deep-dish pizza to gourmet dining experiences. Explore our job listings today and unlock the countless growth opportunities this charming locale has to offer!
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