Clinical Research Coordinator II - Cancer Institute Clinical Research Job at Tampa General Hospital
Department Profile
The TGH Cancer Institute Clinical Research Office is the centralized clinical research enterprise to support all Oncology research. As the hub for all cancer research activities, this office supports all aspects of research including but not limited to trial feasibility, activation, recruitment, and enrollment into Phase I-IV clinical trials; enhancing the opportunities for treatment options for patients in the Tampa Bay area. Tampa General Hospital’s Cancer Institute provides comprehensive care via groundbreaking therapies and advanced diagnostic imaging tools. Through the TGH Cancer Institute, the academic medical center's cancer physicians will offer a highly coordinated range of multidisciplinary specialties such as hematologic malignancies, stem cell, and cellular therapies, neuro-oncology, thoracic, breast, colorectal, urologic, and gynecologic oncology. Our Cancer Institute is among the Top 10% of Hospitals in the Nation for cancer care and one of Florida’s few cancer centers backed by academic medicine. At TGH's Cancer Institute, our world-class cancer care is centered on patient-focused passion and the Cancer Institute continuously explores ways to use cutting-edge diagnostics and treatments.
The Clinical Research Coordinator II of Cancer Clinical Research Office (CCRO) is an integral member of the research team. The Clinical Research Coordinator works independently to support the Principal Investigator by providing study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. Responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries. Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB). Ensures the data quality and integrity for each clinical trial and communication with the Principal investigator, Manager and oversight bodies. While the Principal Investigator is primarily responsible for the overall design, conduct, and management of the clinical trial, the CRC supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study.
Scope:
- Protocol implementation & coordination
- Data collection, entry, reconciliation
- Patient interaction, procedures, scheduling
- Regulatory compliance & reporting
- Audit preparation
- Process improvement
Other related duties as required. The above statements describe the general nature and level of work only. They are not an exhaustive list of all required responsibilities, duties, and skills. Other duties may be added, or this description amended at any time. Remains knowledgeable on current federal, state and local laws, accreditation standards or regulatory agency requirements that apply to the assigned area of responsibility and ensures compliance with all such laws, regulations and standards. Full time presence in the office is required. With department approval 1-2 telecommute days may be permitted.
- Bachelor’s degree in Science or Healthcare related field Master’s degree Science or Healthcare related field
- Two (2) - Three (3) years of direct clinical research experience
- Two (2) years of oncology clinical research experience
- Two (2) years of patient facing responsibilities
- Strong working knowledge of applicable regulations (i.e. FDA, NIH, OHRP, etc.) and demonstrated ability to navigate ambiguous areas
- Demonstrated ability to exercise sound judgement
- Intermediate proficiency in Microsoft Office Experience
- Three (3) years of oncology experience
- Three (3) years of patient facing responsibilities
Licensure, Certification, Registration
- Good clinical practice certification or completion within 3 months
- Basic Cardiopulmonary Life Support or completion within 6 months
- Phlebotomy experience or completion of course work within six months of accepting the position
- IATA, dangerous goods, or equivalent training Licensure, Certification, Registration · Clinical Research Professional certificate (i.e. ACRP, SOCRA, RAPS) · ECG certificate or equivalent
Language Skills
- Read and Write English Language Skills Certified interpreter in additional language
Knowledge, Skills and Ability Requirements:
- Intimate knowledge of advance and complex experimental design, statistics, computerized database
- Demonstrated ability to understand and implement scientific protocols
- Strong working knowledge of applicable regulations
- Demonstrated clinical competency with patient related measurements and with a high degree of accuracy with respect to documentation and data collection
- Ability to work with spreadsheets (such as Excel), familiarity with databases (ex: Medidata RAVE, iMedra, Velos, etc) and querying.
- Excellent interpersonal skills are required for working with the study participants and working as a member of a highly integrated multi-disciplinary team
- Exceptional attention to detail and excellent technical problem-solving skills.
- Excellent organizational skills and ability to prioritize and be flexible to manage multiple tasks.
- Excellent oral and written communication skills.
- Ability to travel between clinical sites, whenever required
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