Responsibilities:

• Perform site qualification, site initiation, interim monitoring, site management activities, and close-out visits
• Evaluate overall performance of site and site staff and provide recommendations regarding site-specific actions
• Verify the process of obtaining informed consent has been adequately performed and documented for each subject/patient
• Assess factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site
• Conduct Source Document Review of appropriate site source documents and medical records
• Verify required clinical data entered in the case report form (CRF) is accurate and complete
• Apply query resolution techniques remotely and on site, and provide guidance to site staff as necessary
• Utilize available hardware and software to support the effective conduct of the clinical study data review and capture
• Verify site compliance with electronic data capture requirements
• Perform investigational product (IP) inventory, reconciliation, and reviews storage and security
• Routinely review the Investigator Site File (ISF) for accuracy, timeliness, and completeness
• Document activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents
• Support subject/patient recruitment, retention, and awareness strategies
• Enter data into tracking systems as required to track all observations, ongoing status, and assigned action items to resolution
• Understand project scope, budgets, and timelines, and manage site-level activities/communication to ensure project objectives, deliverables, and timelines are met
• Act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate
• Prepare for and attend Investigator Meetings and/or sponsor face-to-face meetings
• Provide guidance at the site and project level towards audit readiness standards and support preparation for audit and required follow-up actions

Qualifications:

• Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Good computer skills and ability to embrace new technologies
• Excellent communication, presentation, and interpersonal skills
• Ability to manage required travel of up to 75% on a regular basis

Job Data by YubHub.

As a CRA II, you will perform site qualification, site initiation, interim monitoring, site management activities, and close-out visits to ensure regulatory, ICH-GCP, and protocol compliance.

Responsibilities:

• Perform site qualification, site initiation, interim monitoring, site management activities, and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP, and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.
• Verify the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate.
• Assess factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site.
• Per the Clinical Monitoring/Site Management Plan (CMP/SMP): Assess site processes, conduct Source Document Review of appropriate site source documents and medical records.
• Verify required clinical data entered in the case report form (CRF) is accurate and complete.
• Apply query resolution techniques remotely and on-site, and provide guidance to site staff as necessary.
• Utilize available hardware and software to support the effective conduct of the clinical study data review and capture.
• Verify site compliance with electronic data capture requirements.
• May perform investigational product (IP) inventory, reconciliation, and reviews storage and security.
• Routinely review the Investigator Site File (ISF) for accuracy, timeliness, and completeness.
• Document activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan.
• Support subject/patient recruitment, retention, and awareness strategies.
• Enter data into tracking systems as required to track all observations, ongoing status, and assigned action items to resolution.
• Understand project scope, budgets, and timelines; manage site-level activities/communication to ensure project objectives, deliverables, and timelines are met.
• May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate.
• Prepare for and attend Investigator Meetings and/or sponsor face-to-face meetings.
• Provide guidance at the site and project level towards audit readiness standards and support preparation for audit and required follow-up actions.

Qualifications:

• Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience.
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
• Must demonstrate good computer skills and be able to embrace new technologies.
• Excellent communication, presentation, and interpersonal skills.
• Ability to manage required travel of up to 75% on a regular basis.

Job Data by YubHub.