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Clinical Research Coordinator
2 months ago
Position: Clinical Research Associate
About the Organization
Our institution is a leading center for education and healthcare, dedicated to nurturing the next generation of innovators and healthcare professionals. We are committed to advancing research that enhances the health and well-being of our community and beyond. Our multidisciplinary team is focused on conducting significant clinical trials that contribute to groundbreaking medical advancements.
Role Overview
The Clinical Research Associate will play a vital role in supporting the operations of our Clinical Trials Office (CTO). This office is a collaborative research unit that facilitates physician-led, grant-funded, and industry-sponsored clinical trials.
Key Responsibilities
The responsibilities include, but are not limited to:
- Engaging in the recruitment of study participants, including screening and randomization; managing study documentation, regulatory compliance, and assisting with investigator-initiated studies as needed.
- Analyzing studies to formulate enrollment strategies. Organizing pre-site visits, site initiation visits, and monitoring visits.
- Collaborating effectively with team members, ensuring timely communication and flexibility in scheduling to accommodate both patient and investigator needs.
- Keeping investigators updated on patient conditions and assisting in managing adverse events, adapting workflows as necessary.
- Acting as a patient advocate by coordinating follow-up appointments, collaborating with other departments, and performing required laboratory tests as per study protocols. Responsible for the collection, processing, and inventory management of specimens.
- Maintaining compliance with FDA, sponsor, and institutional review board documentation. Ensuring accurate and timely completion of case report forms and data entry as required.
- Assisting with audit preparations and responding to internal audits as requested.
- Communicating professionally and clearly, particularly when handling sensitive patient information.
- Participating in meetings, training sessions, and workshops as needed.
- Willingness to work flexible hours, including early mornings, evenings, and weekends, with potential on-call responsibilities.
- Managing data entry into electronic data capture systems and maintaining project management tools.
- Performing additional related duties as assigned.
Qualifications
A Master's degree in a relevant field such as chemistry, biology, or health sciences is required, along with experience in research or clinical laboratory settings, particularly in clinical trials; OR a Bachelor's degree with a minimum of three years of research or clinical experience is acceptable.
Preferred Qualifications
Completion of relevant training programs and certifications in clinical research is highly desirable.
Skills and Abilities
Proficiency in Microsoft Office and various databases is essential.
Skills
Strong interpersonal, written, and verbal communication skills. Detail-oriented with excellent organizational capabilities.
Abilities
Ability to maintain confidentiality and work flexible hours as required.
Work Environment
This position involves a commitment to fostering a supportive and customer-friendly environment, ensuring superior service to all stakeholders. We are dedicated to maintaining a workplace that promotes health and well-being for our employees and the community.
Equal Opportunity Employer
We are proud to be an equal opportunity employer, welcoming applicants from diverse backgrounds.