Independently and in collaboration with the Research Nurse, the Clinical Research Coordinator II (CRC II) coordinates Phase I-III therapeutic and non-therapeutic adult and/or pediatric clinical research for local investigator initiated and pharmaceutical sponsored trials. Responsibilities include:
Independent Trial Management/Coordination as a Subject Coordinator
Establish and maintain an understanding of each assigned trial including the related cancer diagnosis and standard of care treatment.
Assist principle investigators and treating physicians identify eligible subjects for registry and non-therapeutic industry and local physician initialed trials.
Participate in consenting process including interpretation of the study for patients and families and other healthcare providers.
Provide each trials with protocol required coordination and scheduling procedures for screening and randomization and enrollment.
Provide ongoing subject coordination while on study and into follow-up including TASCS subject tracking, Oncore trial data management.
Administer study questionnaires and surveys to subjects.
Provide all required research blood and tissue specimen collection including scheduling, lab orders management, kit preparation, collection timing and coordination, initial processing and shipping or storage. Management of research specimens includes inventory control, supply organization and knowledge of the specific study laboratory manual procedures.
Facilitate required tissue samples with BioNet (surgical tissue procurement, the pathology department and or other biopsy procedures.
Assure study and compliance throughout each trial's the life cycle from startup, open to accrual, closed to accrual, follow-up and final closeout. This requires maintaining research regulatory knowledge and ongoing collaboration with CTO regulatory department, study sponsors and principal investigators for any amendments or changes in eligibility.
Abstract data from the medical records and other source documents to complete the subject case report forms as they proceed on trial. This includes baseline transplant information, hospitalization and re-hospitalization, infection reporting, toxicity assessment, disease relapse and progression reporting, adverse events and serious adverse event reporting.
Maintain a working knowledge of medical terminology, critical lab values, understanding of medical conditions and the Common Terminology Critera for Adverse Events (CTCAE v. 4).
Design and maintain systems for timely data collection to meet the requirements of sponsors/monitors.
Correspond with off-site clinics and hospitals medical records and other source information.
Maintain study files and subject documents for each trial that is organized, accessible and retrievable.
Review survival data and diseases status during required subject follow-up that may include family contact and public record/obituary searches.
Maintain understanding and technical capability of the various sponsor electronic data capture systems to ensure complete, accurate, timely submissions and quality data for each assigned trial.
Facilitate and participate in local and sponsor monitoring/audit activities including scheduling, arranging EPIC access, preparing data and resolving identified data queries.
Assist with additional data requires from sponsors and PIs as requested during the trial and for local trial data analysis including meeting interim and data lock deadlines.
Assist with Study Procedures under direction and in collaboration with Nurse Coordinator as a Clinical Research Coordinator
Provide support and collaboration for non-nursing activities for subjects on therapeutic industry sponsored and local investigator initiated trials.
Establish and maintain and understanding of each assigned trial including the related cancer diagnosis and stand are of care treatment.
Maintain a working knowledge of patient eligibility and study specific requirements and procedures for each assigned trial.
Act as a secondary back-up support and coverage to nurse coordinator as needed or requested.
Participate in consenting/screening process with nurse and PI.
Participate in recruitment and pre-screening efforts to promote trial enrollment and accrual.
Manage industry sponsored Central EKG requirements that include initial straining, performing subject EKG and transfer of data.
Provide all blood and tissue specimen collection as defined previously as a subject coordinator.
Assist in the delivery of investigational drug pharmacy dispensed study drug to the clinical setting for subjects to receive from the nurse or PI.
All required qualifications must be documented on application materials.
REQUIRED QUALIFICATIONS: -BA/BS with at least 2 years of experience or a combination of related education and work experience to equal 6 years -Experience must include 2 years’ experience in a research setting to include consenting patients -Experience in data management from patient charts/records (identify, abstract, record, and track) -Understanding and practice of Good Clinical Practices (GCPs), internal regulations (IRB) and standard operating procedures (SOPs) -Experience with Microsoft applications (Word, Access, Excel) -Demonstrated/documented excellent attention to detail, excellent organizational and interpersonal skills, the ability to work independently, as part of a team, and with changing priorities and workloads; and ability to sit for extended periods of time.
PREFERRED QUALIFICATIONS: -BA/BS in science or health related degree -Experience with patient care/contact -Clinical experience -Experience with Allscripts, FCIS, or equivalent electronic medical records system -Knowledge of and experience with medical terminology in a BMT or oncology setting -Oncology experience
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