Description
We are seeking a Senior CRA I to join our Clinical Solutions team. As a Senior CRA I, you will perform site qualification, site initiation, interim monitoring, site management and close-out visits, ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.
Responsibilities:
- Perform site qualification, site initiation, interim monitoring, site management 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 for own and others' activities in the clinical team
- Manage site-level activities / communication to ensure project objectives, deliverables and timelines are met
- Act as primary liaison with project 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
- May provide training or mentorship to more junior level CRAs
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