Description
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
The Clinical Research Associate (CRA) II - Sponsor dedicated - Argentina will perform site qualification, site initiation, interim monitoring, site management activities and close-out visits. The CRA II will ensure regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.
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
- 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
- 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
- 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