Description
Syneos Health is seeking a Clinical Research Associate. As a Clinical Research Associate, you will perform site qualification, site initiation, interim monitoring, site management activities, and close-out visits to ensure regulatory, ICH-GCP, 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
- Verify site compliance with electronic data capture requirements
- May perform investigational product (IP) inventory, reconciliation, and reviews storage and security
- Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness, and completeness
- Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents
- Supports subject/patient recruitment, retention, and awareness strategies
- Enters data into tracking systems as required to track all observations, ongoing status, and assigned action items to resolution
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
Benefits:
- Company car or car allowance
- Health benefits to include Medical, Dental, and Vision
- Company match 401k
- Eligibility to participate in Employee Stock Purchase Plan
- Eligibility to earn commissions/bonus based on company and individual performance
- Flexible paid time off (PTO) and sick time