Comprehensive Blood and Cancer Center is searching for a qualified Clinical Research Coordinator II, to be part of CBCC Research team.
If interested in the position and you meet the the qualifications, please submit your resume to (email@example.com).
Evaluates submissions of new research proposals and revisions for feasibility at site by reviewing protocol, investigator brochure and informed consent form, looking at subject eligibility requirements and determining if those patients are available in the practice, assessing ability to meet timelines in light of other site commitments, and assessing the resources necessary, including people, physical space, and materials to perform the study
Prepares the site for conducting the study by training the people involved, setting up and organizing study files, and creating and/or reviewing study-specific source documents
The CRC II oversees the informed consent process by interacting with the sponsor and IRB for any wording issues, presents the consent to potential subjects, discussing the consent and the study with them, and answering questions. Obtains subject signatures and dates are on the consent forms and documents and files the consents appropriately, and ensures compliance with all relevant Federal and State regulations and requirements.
Informs subjects of amendments and changes and ensures that amended consent forms are implemented and signed.
Manages the study conduct throughout the trial by contacting and screening potential subjects, assisting the investigator with study subject visits, scheduling subject and sponsor visits, preparing for each subject visit, ensuring appropriate study procedures are done, gathering all source documents, and reviewing case report forms are complete and accurate, working with monitors to resolve data queries, managing, and if necessary, performing any laboratory and diagnostic procedures, including supply inventories and completing study closeout activities at end of study.
Maintains databases, researches information, compiles statistics, and gathers and computes various data as required; prepares special reports, summaries, and/or replies to inquiries.
Other duties a CRC may have include serving as a liaison with other departments, maintaining regular communication with the sponsor, or IRB, assisting the investigator with budgeting and contracts, problem-solving, coordinating sponsor or regulatory audits, recruiting new studies, and professionally representing the site to all in the best possible light
Performs other related duties as assigned.
Knowledge with principals, procedures, and ethical considerations surrounding the conduct of invasive and non-invasive research.
Working knowledge of FDA, OHRP, and NIH regulations and guidelines pertaining to the performance, documentation, and reporting of research.
Working knowledge of the operational, logistical, and administrative requirements of laboratory, medical, and/or field research studies.
Knowledgeable with IATA rules and regulations
Working knowledge of Principles, practices and procedures of research protocol
Working knowledge of basic protocol description, patient inclusion and exclusion criteria
Working knowledge of Laws mandating patient information confidentiality
Knowledge of oncology medical terminology and familiar with oncology investigation agents
Demonstrated analytical and problem solving abilities, including skills in making recommendations and decisions.
Communication skills, Interpersonal skills, flexibility, and customer service orientation.
Computer skills, to include database management, word processing, and spreadsheets
Organize resources and establish priorities.
Collecting, analyzing, verifying, and correcting research data.
May provide technical guidance to a variety of individuals, and may assign work to or directly supervise support staff
Providing accurate and timely records
Soliciting sensitive information from patients and other responsible parties
Remaining calm with patients and other parties under stressful conditions
Administrative/procedural decisions and judgments.
Gather data, compile information, and prepare reports.
Communicate effectively, both orally and in writing.
Format and generate summary, statistical, and presentation reports.
Organizing, prioritizing, and scheduling work assignments.
Design and implement systems necessary to collect, maintain, and analyze data.
Communicate on a professional level in both written and verbal formats
Perform multiple tasks in a timely manner
Develop and maintain professional relationships with coworkers
Follow written and verbal directions while retaining the ability to tactfully question directions that seem unclear, unsafe, or illegal
Identify and solve routine problems encountered
Work without supervision when necessary
Provide mentoring and teaching to onsite and remote research staff
Working Knowledge with Title 21-Foods and Drugs Chapter 1- Food and Drug Administration: Department of Health and Human Services
Working knowledge of ICH Guidelines for Good Clinical Practice
Works in a team environment as part of a project team.
Independently works with Internal Regulatory, QA/QC, DEA regulations, adverse event reporting using CTCAE criteria, clinical study planning, filing and reporting, pre-clinical issues, writing SOP's and conducting audits
Working knowledge of Electronic Medical record systems and Electronic Data capture
Functions as resource by providing orientation to department functions and mentoring new staff
Functions independently in the coordination of research subjects by written and oral communication with sponsors, ancillary service providers, physicians, nurses