The Clinical Research Coordinator is responsible for coordinating and overseeing clinical research studies to ensure they are conducted in compliance with regulatory requirements, good clinical practices (GCP), and stud protocols. The ideal candidate will have strong communication skills, attention to detail, and the ability to manage multiple tasks and deadlines in a fast-paced environment.
Study Coordination:
Assist in the planning, initiation, and execution of clinical research studies. Serve as the primary point of contact for study participants, investigators, and sponsors. Coordinate subject recruitment, screening, and enrollment in accordance with the protocol.
Regulatory Compliance:
Ensure that all activities related to the clinical trials comply with local, state, and federal regulations, as well as institutional policies. Maintain accurate and up-to-date study records, including informed consent documents, case report forms, and regulatory binders. Prepare and submit necessary documentation to Institutional Review Boards (IRBs), sponsors, and regulatory agencies.
Patient Care:
Monitor patient progress throughout the study, including assessments, evaluations, and follow-up visits. Educate and inform participants about the study protocol, potential risks, and benefits, ensuring they understand the informed consent process.
Data Management:
Collect, record, and maintain accurate and timely study data. Ensure data integrity and completeness by performing regular data reviews and reconciling discrepancies. Collaborate with the study team to ensure timely reporting of adverse events (AEs) and serious adverse events (SAEs).
Study Documentation:
Maintain study logs, progress reports, and other required documentation. Assist in the preparation of study-related reports and presentations for stakeholders.
Collaboration & Communication:
Work closely with the research team, including Principal Investigators, physicians, and other staff, to facilitate smooth study operations. Communicate study progress and issues to sponsors and regulatory bodies as required.
Training & Support:
Provide training and guidance to junior research staff and support staff as necessary. Stay updated on relevant clinical research trends, regulatory changes, and best practices through continuous education. Any additional duties as assigned. Qualifications and Education Requirements Bachelor's Degree in Life Sciences, Nursing, or related field (Master's preferred) Minimum 2-5 years' clinical research experience, with a strong understanding of clinical trial processes and regulatory requirements. Experience in patient recruitment, data collection, and maintaining study documentation. Strong organizational and project management skills with the ability to drive change in a clinical setting Excellent interpersonal and communication skills to engage with clinical and administrative teams Attention to detail and the ability to manage multiple tasks/studies simultaneously Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and clinical research software/systems. Familiarity with Good Clinical Practices (GCP) and ICH guidelines. In-depth knowledge of federal and institutional regulations, including HIPAA and FDA requirements. Ability to work effectively in a team-oriented, collaborative environment. Flexibility to adjust to evolving research protocols and priorities. Strong problem-solving skills and ability to adapt to changing situations.
Job Type:
Full-time Benefits:
401(k) Dental insurance Employee assistance program Flexible spending account Health insurance Health savings account Life insurance Paid time off Referral program Vision insurance
