Clinical Research Associate
1 week ago
Revel IT is seeking a Clinical Study Associate to join our dynamic team. In this role, you will be an integral part of the Clinical Services Management team, providing essential support to the Clinical Services Project Management Team through a variety of tasks associated with Sponsor's Monitoring Visits and Pharma Partner's audits.
Key Responsibilities:
- Manage on-site administrative tasks to ensure that all monitoring visits and audit requests are executed efficiently and effectively.
- Deliver specific time-sensitive tasks under the guidance of the study Project and/or Program Managers.
- Ensure compliance with the Roche CDx CAP/CLIA Laboratory quality system in all activities.
- Collaborate closely with Quality, Roche CDx CAP/CLIA Laboratory, and Pathologist to maintain high standards.
- Coordinate schedules for Site Initiation Visits, Monitoring Visits, and Audits.
- Maintain and prepare laboratory and study documentation for auditors, ensuring all logs and records are up to date.
- Facilitate monitoring visit activities and ensure effective communication with all stakeholders.
- Complete supplier questionnaires and manage documentation timelines efficiently.
- Engage in process improvement initiatives to enhance operational efficiency.
- Undertake additional responsibilities as assigned by Clinical Services Management.
Qualifications:
- A Bachelor’s degree in life sciences, nursing, or a related field is preferred.
- Experience in administrative management or clinical research is advantageous.
Skills and Attributes:
- Exceptional communication skills, both written and verbal, with proficiency in English; additional languages are a plus.
- Proficient in Microsoft Office Suite and Google Tools.
- Strong organizational skills with the ability to manage multiple tasks simultaneously.
- Positive attitude with a proactive approach to challenges.
- Detail-oriented with a commitment to timely delivery of tasks.
- Able to work independently and collaboratively within a team.
- Possesses critical thinking and problem-solving abilities.
- Customer-focused with a service-oriented mindset.
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