Job Description
We are seeking a highly skilled Clinical Research Associate II to join our team. The successful candidate will be responsible for performing site qualification, site initiation, interim monitoring, site management activities, and close-out visits to ensure regulatory compliance.
The CRA II will verify the process of obtaining informed consent, assess factors that might affect subject/patient safety and clinical data integrity, and conduct source document review of site source documents and medical records.
The role involves applying query resolution techniques remotely and on-site, providing guidance to site staff as necessary, and driving query resolution to closure within agreed timelines.
The CRA II may also perform investigational product inventory, reconciliation, and reviews storage and security, and verify issues or risks associated with blinded or randomized information related to IP.
In addition, the CRA II will routinely review the Investigator Site File (ISF) for accuracy, timeliness, and completeness, reconcile contents of the ISF with the Trial Master File (TMF), and ensure the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
The CRA II will document activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan.
Furthermore, the CRA II will enter data into tracking systems as required to track all observations, ongoing status, and assigned action items to resolution, and prepare for and attend Investigator Meetings and/or sponsor face-to-face meetings.
The CRA II will provide guidance at the site and project level towards audit readiness standards and support preparation for audit and required follow-up actions.
Additional responsibilities include site support throughout the study lifecycle from site identification through close-out, knowledge of local requirements for real-world late-phase study designs, chart abstraction activities and data collection, collaboration with Sponsor affiliates, medical science liaisons, and local country staff, training junior staff, identifying and communicating out-of-scope activities to Lead CRA/Project Manager, and proactively suggesting potential sites based on local knowledge of treatment patterns, patient advocacy, and Health Care Provider associations.
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
We offer a dynamic work environment, opportunities for career growth and development, and a competitive compensation package.
Our company is committed to building a diverse, inclusive, and authentic workplace where employees can thrive and make a meaningful contribution.
We encourage applicants to apply who share our values and are passionate about delivering high-quality results in a fast-paced environment.
About Us
We are a leading integrated biopharmaceutical solutions organization built to accelerate customer success.
We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities.
We believe in empowering our employees to take initiative, challenge the status quo, and drive innovation in a highly competitive and ever-changing environment.