Scorpion Therapeutics
Role Summary
Oncology - CRA II - Remote US. Experienced Oncology CRA 2s to lead and support a Full Service Outsourcing team. CAR-T desired. Open to major hub locations on the East & West Coast. 60-70% travel, 8-10 DOS per month. Responsibilities
Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned Responsible for all aspects of site management as prescribed in the project plans General On-Site Monitoring Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document monitoring data for missing or implausible data Responsible for all aspects of registry management as prescribed in the project plans Undertake feasibility work when requested Complete Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs Independently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by management Assist with training of new employees, e.g., co-monitoring Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable) and may act as a local client contact as assigned Perform other duties as assigned by management Qualifications
University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure) 1 - 3+ years of Clinical Monitoring experience Oncology experience is desired Open to various hub locations Skills
Ability to work in a fast-paced environment with strict protocol adherence Adaptability to changing priorities Strong teamwork and people skills Technology-based data collection in an electronic environment Education
As listed in Qualifications (degree or related certification) Additional Requirements
Travel: 60-70% travel, including domestic and occasional international travel
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Oncology - CRA II - Remote US. Experienced Oncology CRA 2s to lead and support a Full Service Outsourcing team. CAR-T desired. Open to major hub locations on the East & West Coast. 60-70% travel, 8-10 DOS per month. Responsibilities
Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned Responsible for all aspects of site management as prescribed in the project plans General On-Site Monitoring Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document monitoring data for missing or implausible data Responsible for all aspects of registry management as prescribed in the project plans Undertake feasibility work when requested Complete Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs Independently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by management Assist with training of new employees, e.g., co-monitoring Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable) and may act as a local client contact as assigned Perform other duties as assigned by management Qualifications
University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure) 1 - 3+ years of Clinical Monitoring experience Oncology experience is desired Open to various hub locations Skills
Ability to work in a fast-paced environment with strict protocol adherence Adaptability to changing priorities Strong teamwork and people skills Technology-based data collection in an electronic environment Education
As listed in Qualifications (degree or related certification) Additional Requirements
Travel: 60-70% travel, including domestic and occasional international travel
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