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Oncology Research Project Manager
2 months ago
The Clinical Research Coordinator serves as the primary contact for clinical research studies, responsible for the comprehensive management of assigned trials from initiation to completion. This role operates under the guidance of the Principal Investigator and Clinical Trial Management, ensuring strict adherence to regulatory standards including FDA, ICH-GCP, IRB, HIPAA, and organizational policies.
KEY RESPONSIBILITIES:
- Exhibit a thorough understanding of study protocols and their requirements.
- Oversee the quality of clinical trial documentation and adapt the protocol schedule as necessary.
- Conduct study-specific tasks under the supervision of the Principal Investigator and Clinical Trial Management, maintaining high standards of quality.
- Identify, recruit, and enroll eligible patients utilizing electronic medical records and clinical trial management systems.
- Maintain detailed enrollment logs throughout the trial process.
- Coordinate patient appointments, ensuring all necessary tests and procedures are scheduled and followed up on.
- Collaborate effectively with a multidisciplinary team involved in the trial, including administrative and clinical staff.
- Manage study materials, including drug accountability and destruction records.
- Input data into electronic data capture systems and medical records promptly.
- Address and resolve data queries efficiently.
- Monitor patient safety and report any adverse events or protocol deviations in a timely manner.
- Assist in the collection of essential regulatory documents required for compliance.
- Ensure adherence to all relevant guidelines and policies throughout the study.
- Provide regular updates to the study team regarding workflow changes or patient needs.
- Oversee logistical aspects of clinical trials, including infusion assignments and data management.
- Engage with research sponsors and regulatory bodies on study-related matters.
- Support audit processes and address protocol-related issues proactively.
- Handle biological materials according to established protocols and safety standards.
- Facilitate regular meetings to discuss trial progress and address any challenges.
- Track patient reimbursements related to clinical trials.
- Perform additional duties as assigned.
Qualifications:
Certified Clinical Research Professional (ACRP or SoCRA) with a minimum of one year of experience in oncology trials, or a high school diploma with four years of relevant experience. Proficient in computer applications with strong communication skills. Previous experience in regulatory affairs is advantageous.
Must be available for onsite work during standard business hours across the network.
Experience with centrifugation and handling biological specimens is preferred.
Demonstrated ability to manage multiple tasks effectively in a dynamic environment.
