Description
Syneos Health is seeking a CRA II - Sr CRAI, Clin Ops BU, South Korea.
As a CRA II - Sr CRAI, Clin Ops BU, South Korea, 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 (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 via review of site source documents and medical records.
- 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 for own and others’ activities in the clinical team.
- Manage site-level activities / communication to ensure project objectives, deliverables and timelines are met.
- May 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.
- 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.