Description
Syneos Health is seeking a Clinical Research Associate I to perform site qualification, site initiation, interim monitoring, site management activities, and close-out visits. The successful candidate will have a Bachelor's degree or RN in a related field, knowledge of Good Clinical Practice/ICH Guidelines, and excellent communication and interpersonal skills.
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 process of obtaining informed consent, assess factors affecting subject/patient safety and clinical data integrity
- Conduct Source Document Review, verify required clinical data entered in case report form (CRF) is accurate and complete
- Apply query resolution techniques, provide guidance to site staff as necessary
- Utilize available hardware and software to support clinical project data review and capture
- May perform investigational product (IP) inventory, reconciliation, and reviews storage and security
- Routinely review 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
- Prepare for and attend Investigator Meetings and/or sponsor face-to-face meetings
- Provide guidance at site and project level towards audit readiness standards
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
Benefits:
- Company car or car allowance
- Health benefits, including 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