OncoC4, Inc
Senior Clinical Research Associate – Midwest
OncoC4, Inc, Midwest, Wyoming, United States, 82643
Senior Clinical Research Associate – Midwest
RESPONSIBILITIES Senior Clinical Research Associate (CRA)-Midwest will act as the primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites (Midwest) to support ongoing and future OncoC4 clinical trials of novel immune therapies for various cancers. CLINICAL SITE MONITORING AND MANAGEMENT Develops strong investigative site relationships and ensures continuity of investigative site relationships through all phases of the trial Conducts site visits including but not limited to Pre-study visits, initiation visits, interim monitoring visits, close-out visits to ensure compliance with protocols, Sponsor SOPs, ICH/GCP and all applicable regulations Performs remote and on-site monitoring & oversight activities using various tools to ensure data generated at the site are complete, accurate, and unbiased; subjects’ rights, safety, and well-being are protected Collects, reviews, and monitors required regulatory documents for study start-up, study maintenance, and study close-out Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, missing data and data queries, protocol deviations, regulatory documentation, site audits/inspections, and overall site performance Identifies, assesses, and resolves site performance, quality, or compliance problems and escalates per protocol to upper management Performs investigational product accountability through physical inventory and record review Participates & provides inputs on site selection activities Supports audit/inspection activities as needed Work with in-house Clinical Trial Assistant to collect, review, and monitor required regulatory documentation for study start-up, study maintenance, and study close-out. Manages and maintains information and documentation in Clinical Trial Management System, electronic Trial Master File, and various other systems as appropriate and per timelines REQUIRED KNOWLEDGE, SKILLS AND ABILITIES Excellent understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines Demonstrated high level of monitoring skill with independent professional judgment. Demonstrated understanding of medical/therapeutic area knowledge (oncology) and medical terminology Knowledge of e-TMF and CTMS set up and maintenance processes Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint Excellent written and verbal communication skills including good command of English Proven skills in site management including independent management of site performance and patient recruitment Effective time management and organizational skills Ability to establish and maintain effective working relationships with coworkers POSITION REQUIREMENTS Bachelor’s degree in Sciences from an accredited institution with strong emphasis in science and/or biology Minimum of 3 to 4 years of clinical monitoring and direct site management experience in a bio/pharma/ Clinical Research Organization Experience monitoring oncology trials is required Applicants may be eligible to work remotely depending on location Ability to travel domestically approximately 50% of working time
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RESPONSIBILITIES Senior Clinical Research Associate (CRA)-Midwest will act as the primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites (Midwest) to support ongoing and future OncoC4 clinical trials of novel immune therapies for various cancers. CLINICAL SITE MONITORING AND MANAGEMENT Develops strong investigative site relationships and ensures continuity of investigative site relationships through all phases of the trial Conducts site visits including but not limited to Pre-study visits, initiation visits, interim monitoring visits, close-out visits to ensure compliance with protocols, Sponsor SOPs, ICH/GCP and all applicable regulations Performs remote and on-site monitoring & oversight activities using various tools to ensure data generated at the site are complete, accurate, and unbiased; subjects’ rights, safety, and well-being are protected Collects, reviews, and monitors required regulatory documents for study start-up, study maintenance, and study close-out Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, missing data and data queries, protocol deviations, regulatory documentation, site audits/inspections, and overall site performance Identifies, assesses, and resolves site performance, quality, or compliance problems and escalates per protocol to upper management Performs investigational product accountability through physical inventory and record review Participates & provides inputs on site selection activities Supports audit/inspection activities as needed Work with in-house Clinical Trial Assistant to collect, review, and monitor required regulatory documentation for study start-up, study maintenance, and study close-out. Manages and maintains information and documentation in Clinical Trial Management System, electronic Trial Master File, and various other systems as appropriate and per timelines REQUIRED KNOWLEDGE, SKILLS AND ABILITIES Excellent understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines Demonstrated high level of monitoring skill with independent professional judgment. Demonstrated understanding of medical/therapeutic area knowledge (oncology) and medical terminology Knowledge of e-TMF and CTMS set up and maintenance processes Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint Excellent written and verbal communication skills including good command of English Proven skills in site management including independent management of site performance and patient recruitment Effective time management and organizational skills Ability to establish and maintain effective working relationships with coworkers POSITION REQUIREMENTS Bachelor’s degree in Sciences from an accredited institution with strong emphasis in science and/or biology Minimum of 3 to 4 years of clinical monitoring and direct site management experience in a bio/pharma/ Clinical Research Organization Experience monitoring oncology trials is required Applicants may be eligible to work remotely depending on location Ability to travel domestically approximately 50% of working time
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