Sr. Clinical Research Coordinator

Job Description - Sr. Clinical Research Coordinator (2600007H)

The Senior Clinical Research Coordinator independently leads day-to-day operations of clinical research studies conducted by a principal investigator with limited supervision. The role involves complex duties in the collection, compilation, documentation and analysis of clinical research data, and development of progressive functional knowledge of Good Clinical Practices (GCP), Office of Human Research Protections (OHRP) regulations, and Food and Drug Administration (FDA) regulations.

This position may support multiple investigators and provide direction to Clinical Research Assistants and Clinical Research Coordinators as assigned.

The Senior Clinical Research Coordinator provides comprehensive clinical research support across all phases of a study, including IRB submission, regulatory compliance, study start-up, implementation, and close-out. This role independently leads day-to-day study operations for principal investigators with limited supervision and manages complex activities related to the collection, documentation, analysis, and reporting of clinical research data. The Senior Clinical Research Coordinator applies advanced knowledge of GCP, OHRP, and FDA regulations to ensure regulatory and ethical conduct of research.

This position may support multiple investigators across clinical and translational research projects and provides functional oversight and direction to Clinical Research Assistants and Clinical Research Coordinators as assigned.

• Responsible Conduct of Research:
  Consistently demonstrates adherence to the standards for the responsible conduct of research; plans, conducts and manages research projects within federal and institutional regulations and policies under the direction of the principal investigator; stays informed of and adheres to institutional policies, and federal regulations (e.g., Titles 21 and 45 CFR) and guidances regarding human subjects’ research and use of protected health information;
  
  uses research funds and resources appropriately; maintains confidentiality of data as required; meets all annual job-related training and compliance requirements.
• Research Administration:
  Maintains knowledge and comprehension of assigned research protocols, including study procedures, timelines and eligibility; accurately creates, completes, maintains, organizes and accounts for study materials; uses and accounts for research funds and resources; attends study meetings (which could include overnight travel); collaborates effectively with the research team; serves as liaison between investigators, sponsors, hospital departments involved with research studies and the Clinical Research Center;
  
  identifies and resolves issues; reviews journals and literature; creates SOPs and implements operational plans; provides oversight and training to study team members; develops study documents (consent forms and protocols); adheres to the IRB-approved recruitment plan; screens subjects for eligibility; communicates with diverse populations; engages participants/LARs in the informed consent process.
• Study Management:
  Conducts/participates in feasibility assessments; plans, conducts and manages research activities in accordance with federal regulations and policies; ensures regulatory integrity of protocols through accurate submission of documents to sponsor, IRB and oversight bodies; authors study submissions and related documents; registers and records participant visits; anticipates study needs and workload to meet objectives; coordinates for oversight visits and audits; independently authors reports to oversight bodies and trains staff.
• Data Collection:
  Ensures data is collected as required by protocol and data principles; resolves data queries within sponsor and institutional timelines; plans and performs specimen collection, labeling and storage/shipping as assigned; maintains sample accountability/chain of custody; ensures secure storage of study documents; anticipates and responds to customer needs and follows up until needs are met.
• Teamwork/Communication:
  Demonstrates collaborative and respectful…