Senior Clinical Research Coordinator

Position Summary

The Senior Clinical Research Coordinator will collaborate with internal and external stakeholders to help drive the evolution of a modern, compliant and ethical repository to advance brain tumor research capacity. The Senior Clinical Research Coordinator will play a crucial role in the expansion of the Brain Tumor Biorepository. Specifically, the individual will lead the development and implementation of new processes and procedures necessary to integrate existing biobanking efforts with a novel platform where genomic data from patient material will be deposited for real-time analysis. Additionally, the Senior Clinical Research Coordinator independently will lead day-to-day operations of clinical research studies. The individual performs a variety of complex duties involved in the collection, compilation, documentation and analysis of clinical research data. The Senior Clinical Research Coordinator will develop a progressive functional knowledge of Good Clinical Practices (GCP), Office of Human Research Protections (OHRP) regulations and Food and Drug Administration (FDA) regulations. This individual may support multiple investigators with clinical and translational research projects and direct the work of a Clinical Research Assistant and Clinical Research Coordinator as assigned. The Senior Clinical Research Coordinator will work closely with the Principal Investigator and other members of the research team to ensure that the biorepository is fully annotated, harmonized across all data sources, and accessible to collaborators worldwide through an online dashboard. Key responsibilities of the role include establishing an automated platform for tissue processing, expanding the biorepository to include additional correlative specimens, and harmonizing consent forms. The Senior Clinical Research Coordinator will also play a key role in facilitating multiple investigator access to the biorepository, developing a RedCap platform for this purpose.

Required Skills and Qualifications

• Ability to manage multiple complex activities while maintaining close attention to detail and not losing sight of the organizational mission.
• Interpersonal skills that demonstrate formal and informal leadership in a diverse professional environment.
• Familiarity with databases, data collection tools and data analysis methods.
• Bachelor’s degree in a related field (e.g., Biology, Chemistry, Medical Records Management, etc.).
• Knowledge of clinical research designs and needed infrastructure.

Responsible Conduct of Research

• Plans, conducts and manages research projects within federal and institutional regulations and policies under the direction of the principal investigator.
• Consistently demonstrates adherence to the standards for the responsible conduct of research.
• Stays informed of and adheres to institutional policies, and federal regulations (e.g. Titles 21 and 45 of the Code of Federal Regulations) and guidances (International Counsel on Harmonization) regarding human subjects’ research and use of protected health information.
• Maintains confidentiality of data as required.
• Uses research funds and resources appropriately.
• Meets all annual job-related training and compliance requirements.

Research Administration

• Develops study documents, including consent forms and protocols.
• Uses and accounts for research funds and resources at performance level, including reconciling research subject billing if assigned.
• Identifies and resolves issues and challenges with appropriate input and oversight.
• Provides oversight and training to study team members for a variety of studies.
• Accurately creates, completes, maintains, organizes and accounts for study materials, including participant lists and visit logs, regulatory binders, case report forms, laboratory kits, investigational product(s) and participation incentives.
• Serves as an effective liaison between the investigators, sponsors, hospital departments involved with research studies and the Clinical Research Center.
• Maintains knowledge and comprehension of assigned research protocols, including study procedures, timelines and eligibility.
• Works well with other members of the research team, appreciates a diverse workplace and seeks and provides input when appropriate.
• Reviews journals, abstracts and scientific literature to obtain information relevant to clinical research programs.
• Creates standard operating procedures (SOPs), and implements operational plans.
• Attends study meetings, which could include overnight travel, as requested by principal investigator.

Participant Enrollment

• Interacts with study participants and/or legally authorized representatives (LARs) to communicate study purpose and participation details and to assess participation interest.
• Communicates effectively and provides information to a diverse, vulnerable subject population in accordance with institutional policies.
• Screens subjects for eligibility per the protocol and institutional policies.
• Adheres to the IRB-approved recruitment plan.
• Engages participants/LARs in the informed consent process according to institutional policies.

Study Management

• Ensures regulatory integrity of protocols through the accurate and timely preparation and submission of documents and reports to the sponsor, IRB and other oversight bodies in accordance with federal regulations, sponsor SOPs and institutional policies.
• Registers and records participant visits in the appropriate tracking system.
• Authors study submissions and related documents based on functional role; this may include IRB contingency responses, ClinicalTrials.gov postings, Certificate of Confidentiality applications and scholarly presentations and publications.
• Plans, conducts and manages research activities in accordance with federal regulations and guidance documents and based on functional role; this may include IRB contingency responses, ClinicalTrials.gov postings, Certificate of Confidentiality applications and scholarly presentations and publications.
• Coordinates, prepares for and responds to routine oversight body visits and audits.
• Conducts/participates in feasibility assessments to ensure adequate site resources and infrastructure are available for protocol participation.
• Anticipates study needs and subject caseload to meet organizational objectives and deadlines in a timely manner.
• Independently authors reports to oversight bodies and/or trains and oversees staff performing these tasks.

Data Collection

• Ensures secure storage of study documents.
• Ensures that queries are resolved within sponsor and institutional timelines.
• Plans and performs research specimen collection, labeling and storage/shipping if assigned; maintains accurate sample accountability/chain of custody documentation.
• Ensures data is collected as required by protocol and in accordance with research data principles (ALCOAC: Attributable, Legible, Contemporaneous, Original, Accurate and Complete).