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Clinical Research Specialist I-III
2 months ago
Clinical Research Coordinator - Medix™
Job Overview
The Clinical Research Coordinator plays a pivotal role in overseeing and facilitating the execution of clinical research protocols. These protocols may be supported by various funding sources, including industry partners, cooperative groups, or grant-funded initiatives. This position is essential in ensuring the effective management and operation of clinical research activities, focusing on participant recruitment, adherence to protocols, participant safety, and data integrity.
Key Responsibilities
- Lead the management of clinical research protocols to ensure successful participant recruitment and compliance with study guidelines.
- Collaborate closely with the clinical research team to develop monitoring tools for tracking trial progress and reporting.
- Engage with institutional investigators and healthcare team members to facilitate the smooth conduct of clinical trials.
- Maintain flexibility in work hours to cover study responsibilities as needed.
Qualifications
- Bachelor's Degree (Required)
- Master's Degree (Preferred)
Certifications
- CCRC - Certified Clinical Research Coordinator (Preferred)
- CCRP - Certified Clinical Research Professional (Preferred)
- CCRA - Certified Clinical Research Associate (Preferred)
Experience
- Minimum of 2 years in clinical research (Required)
- At least 2 years of experience with oncology clinical trials (Required)
- Knowledge of chemotherapy and/or radiation therapy administration (Required)
General Duties
- Adhere to all relevant policies, procedures, and accreditation standards, ensuring patient confidentiality and compliance with regulations.
- Promote and uphold safety standards within the clinical research environment.
- Participate in staff meetings and complete required training and evaluations timely.
- Stay informed about current practices and advancements in clinical research.
Communication and Collaboration
- Act as a liaison between investigators and pharmaceutical companies, ensuring effective communication and collaboration.
- Foster strong relationships with research participants and interdisciplinary team members.
- Assist in evaluating clinical research studies and provide constructive feedback to relevant parties.
Participant Coordination
- Support investigators in identifying potential research participants for ongoing clinical trials.
- Ensure eligibility criteria are met prior to participant registration.
- Monitor and document adverse events and treatment toxicities reported by participants.
Research Administration
- Design and manage systems for organizing and controlling workflow related to clinical research activities.
- Ensure compliance with federal and institutional guidelines to protect research participants' rights and well-being.
- Conduct ongoing evaluations of clinical research activities and recommend improvements.
Quality Assurance
- Review protocol study forms for accuracy and compliance with Good Clinical Practice.
- Assist in gathering necessary documents for institutional audits and site visits.
This role at Medix™ is vital for the successful execution of clinical research, ensuring that all activities are conducted in accordance with established standards and regulations, while prioritizing participant safety and data quality.
