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Clinical Trials Coordinator
2 months 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.
Job Overview:
- Your responsibilities will include managing on-site administrative tasks to ensure that all monitoring visits and audit requests are executed efficiently and punctually.
Key Responsibilities:
- The Clinical Study Associate will be accountable for delivering specific tasks under the guidance of the study Project and/or Program Managers.
- Tasks are time-sensitive and will require diligent follow-up.
- Ensure that all activities comply with the Roche CDx CAP/CLIA Laboratory quality system.
- Collaborate closely with Quality, Roche CDx CAP/CLIA Laboratory, and Pathologist.
- Manage calendars to coordinate times for Site Initiation Visits, Monitoring Visits, Closing Visits, and Audits.
- Maintain and prepare laboratory and study documents for auditors, ensuring compliance with documentation standards.
- Keep Delegation of Authority (DOA) Logs current, ensuring that all personnel listed have completed necessary training.
- Work with the Lab Manager to ensure timely provision of documentation and that new personnel are updated on DOAs.
- Facilitate and/or participate in Monitoring Visit activities.
- Complete Supplier Questionnaire Documents, ensuring timely follow-up with Subject Matter Experts.
- Maintain and manage questionnaire dates and document maintenance.
- Engage in process improvement initiatives as required.
- Additional responsibilities may be assigned by Clinical Services Management.
Required Qualifications:
- A Bachelor’s degree in life sciences, nursing, or a related field is preferred.
- Experience in Business Administration or a similar field is acceptable.
Experience:
- Minimum of 2 years in administrative management, entry-level CRA, or CTA experience, preferably with a background in histo-technology laboratories.
Skills and Competencies:
- Excellent communication skills, proficient in English (both written and verbal); knowledge of additional languages is a plus.
- Proficient in Microsoft Office Suite (Word, Excel, PowerPoint) and Google Tools.
- Strong organizational skills with the ability to manage multiple tasks simultaneously.
- Positive, energetic attitude with a proactive approach.
- Ability to adapt and thrive in a fast-paced environment.
- Meticulous attention to detail and a commitment to timely delivery.
- Self-motivated and able to work both independently and collaboratively.
- Strong critical thinking and problem-solving abilities.
- Customer-focused with a service-oriented mindset.
- Ability to communicate effectively with various internal stakeholders in a professional manner.
- Experience in cancer research and familiarity with ICH-GCP guidelines related to clinical trials is advantageous.
- Experience working in global environments is beneficial.