Job Title: Clinical Research Associate I (CRA I)
Department: Clinical Operations
Reporting To: Lead CRA/Project Manager
Role Overview:
The Clinical Research Associate I (CRA I) is responsible for performing clinical trial site management activities to ensure compliance with protocols, Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, and applicable regulations. This role includes on-site and remote monitoring, fostering effective communication with clinical sites, and ensuring the integrity of clinical trial data.
Key Responsibilities:
Site Management and Monitoring:
Conduct site qualification, initiation, monitoring, and close-out visits, ensuring adherence to protocol and regulatory requirements.
Evaluate site and staff performance, escalating significant issues to the project team and developing site-specific action plans as needed.
Verify informed consent process documentation and ensure patient confidentiality and data integrity.
Compliance and Data Accuracy:
Perform source document review and ensure clinical data entered in case report forms (CRFs) is accurate and complete.
Resolve data queries and guide site staff to achieve timely query resolution.
Monitor investigational product (IP) handling, storage, reconciliation, and security according to protocol and GCP.
Documentation and Reporting:
Maintain accurate and timely documentation, including confirmation letters, follow-up letters, trip reports, and communication logs.
Reconcile Investigator Site File (ISF) with the Trial Master File (TMF) and ensure proper archiving of essential documents.
Update tracking systems to monitor observations, site statuses, and action items.
Training and Collaboration:
Act as a primary liaison with site personnel and ensure site teams are trained and compliant with regulatory requirements.
Provide guidance and prepare sites for audits and follow-up actions.
Collaborate with other CRAs, Central Monitoring Associates (CMAs), and sponsor representatives.
Real World Late Phase Studies:
Support site operations from identification to close-out.
Conduct chart abstraction and data collection for real-world evidence.
Collaborate with sponsor affiliates, medical science liaisons, and local teams.
Project and Quality Management:
Ensure assigned site activities align with project timelines, scope, and budgets.
Participate in Investigator Meetings and sponsor meetings as required.
Support patient recruitment, retention, and awareness strategies.
Qualifications:
Education and Experience:
Bachelor’s degree in a related field or RN qualification (or equivalent combination of education, training, and experience).
Understanding of Good Clinical Practice (GCP), ICH Guidelines, and applicable regulatory requirements.
Skills and Competencies:
Proficient in computer applications and adaptable to new technologies.
Strong interpersonal, communication, and presentation skills.
Effective organizational and time-management skills.
Ability to handle extensive travel (up to 75%).
Why Join Syneos Health?
Opportunity to collaborate on impactful projects with industry leaders.
Career development through structured training and progression pathways.
Inclusive and supportive workplace culture prioritizing employee well-being.
Experience with groundbreaking studies contributing to medical advancements.
Additional Information:
Responsibilities may be adjusted based on business needs.
Syneos Health is committed to providing equal employment opportunities and reasonable accommodations in compliance with relevant legislation.
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