Description
We are looking for a Senior Clinical Research Associate (CRA) in Immunology to join our team. As a Sr CRA, you will be responsible for performing site qualification, site initiation, interim monitoring, site management, and close-out visits. You will ensure regulatory, ICH-GCP, and protocol compliance, and provide guidance to site staff as necessary.
Responsibilities:
- Perform site qualification, site initiation, interim monitoring, site management, and close-out visits
- Ensure regulatory, ICH-GCP, and protocol compliance
- Provide guidance to site staff as necessary
- Verify informed consent process and document confidentiality
- Assess site processes and conduct source document reviews
- Apply query resolution techniques and provide guidance to site staff
- Utilize available hardware and software to support clinical study data review and capture
- Verify site compliance with electronic data capture requirements
- Perform investigational product 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, and communication logs
- Support subject/patient recruitment, retention, and awareness strategies
- Enter data into tracking systems as required
- Understand project scope, budgets, and timelines
- Manage site-level activities and communication
- Act as primary liaison with project site personnel
- Prepare for and attend Investigator Meetings and sponsor face-to-face meetings
- Provide guidance at the site and project level towards audit readiness standards
- May provide training or mentorship to more junior level CRAs
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