Description
Syneos Health is seeking a Clinical Research Associate (CRA) to join their team in Portugal.
As a CRA, you will be responsible for performing site qualification, site initiation, interim monitoring, site management activities, and close-out visits to ensure regulatory, ICH-GCP, and protocol compliance.
Key responsibilities include:
- Evaluating the overall performance of site and site staff and providing recommendations regarding site-specific actions
- Communicating and escalating serious issues to the project team and developing action plans
- Maintaining a working knowledge of ICH/GCP Guidelines, relevant regulations, and company SOPs/processes
- Verifying the process of obtaining informed consent has been adequately performed and documented for each subject/patient
- Assessing factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site
- Conducting Source Document Review of appropriate site source documents and medical records
- Applying query resolution techniques remotely and on-site, and providing guidance to site staff as necessary
- Utilizing 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 reviewing the Investigator Site File (ISF) for accuracy, timeliness, and completeness
- Documenting activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents
- Supporting subject/patient recruitment, retention, and awareness strategies
- Entering data into tracking systems as required to track all observations, ongoing status, and assigned action items to resolution
- Understanding project scope, budgets, and timelines, and managing 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
- Preparing for and attending Investigator Meetings and/or sponsor face-to-face meetings
- Providing guidance at the site and project level towards audit readiness standards and supporting 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 adapt to new technologies
- Excellent communication, presentation, and interpersonal skills
- Ability to manage required travel of up to 75% on a regular basis