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Senior Clinical Research Coordinator

2 months ago

Washington, United States Medstar Full time

Position Overview
We are seeking a skilled and experienced Senior Clinical Research Coordinator to become a vital part of our Oncology research team at MedStar Health Research Institute. This role requires an individual who can operate independently and efficiently with minimal supervision, taking charge of the comprehensive coordination of clinical research activities across all phases and complexities, including high-profile or investigator-initiated studies.

Key Responsibilities
1. **Regulatory Oversight**: Manage, prepare, submit, and maintain all necessary regulatory documentation (such as new studies, annual reviews, and amendments) accurately and promptly. Conduct periodic self-audits to ensure compliance and readiness for external audits.
2. **Informed Consent Management**: Supervise the informed consent process, ensuring participants fully understand the study and have adequate time to consider their involvement. Adhere to Good Clinical Practices (GCPs) and educate both new staff and participants on protocol expectations.
3. **Data Management**: Ensure timely updates of research participant encounters in electronic systems, overseeing data entry and validation to maintain accuracy and completeness. Address data queries and support the data management process for clinical research projects.
4. **Participant Safety Monitoring**: Optimize participant safety by monitoring and reporting adverse events, assisting investigators in evaluating the seriousness and causality of such events, and implementing necessary interventions.
5. **Budget Collaboration**: Work closely with investigators and administrative leadership to prepare and confirm the accuracy of study budgets, ensuring compliance with all contractual terms and conditions.
6. **Billing Compliance**: Understand and comply with billing regulations for services rendered in the context of clinical research, ensuring proper registration and billing of study procedures.
7. **Study Coordination**: Facilitate internal and external audits, assist in project team meetings, and coordinate multi-center studies as needed. Act as a liaison among research participants, investigators, sponsors, and healthcare professionals, providing clear and detailed communication.

Qualifications
- **Education**: Bachelor’s degree in a relevant field or an allied health profession, or equivalent work experience.
- **Experience**: A minimum of 3-4 years of experience as a clinical research coordinator or in a related field, demonstrating a strong aptitude for research facilitation.
- **Skills**: Excellent verbal and written communication abilities, strong organizational skills, and proficient computer skills.

This position offers a competitive salary range, reflecting the experience and expertise of the successful candidate.