Clinical Research Coordinator

Description:

Manages and coordinates the care of patients participating in a clinical research study with guidance from preceptor, educator and/or administrator; educates patients, families and staff regarding study compliance; collects a complete and accurate study data set and facilitates accrual to clinical research studies.

Coordinates, implements and maintains compliance of clinical research studies.

Develops pre-printed chemotherapy orders and prescriptions for each clinical research study; ensures that the preprinted orders are reviewed and approved by the Principal Investigator and Investigational Drug Services; responds to all questions and concerns of Roswell Park and clinical staff related to the study orders.

Ensures Clinicians order all procedures and tests specifically related to the clinical research study and monitors results.

Reviews all assigned clinical research studies and amendments for feasibility of implementation.

Communicates with non-study staff involved in the implementation of clinical research studies, their role in the implementation of the study. Develops educational tools and records attendance for all educational activities related to the implementation of the study.

Coordinates and plans the implementation of assigned studies by obtaining detailed knowledge of all components of the clinical research studies through independent analysis, review of the study prior to initiation and attendance at sponsor investigator meetings; serves as a resource regarding assigned studies to others involved with the study implementation.

Devises, plans, and implements strategies and systems necessary to ensure adherence to and compliance with the assigned clinical research studies.

Assists in the development of case report forms and research data bases in collaboration with CRS data management as requested.

Collaborates with the CRS financial team to assure compliance with protocol billing.

Ensures that the required information is complete, accurate, and readily available for clinical research audits or study sponsor monitor visits, i.e.: medical records, case report forms and other source documents. CRC is available during monitor site visits or audits to answer questions and resolve identified issues and concerns.

Collects information and completes and submits data to oversight committees, for example, IRB, Early Phase Clinical Trial Committee, Data Safety Monitoring & Accrual Board, Response Review committee, and IND reports.

Collaborates and identifies Serious Adverse Events (SAE), Adverse Events (AE), and Unanticipated Problems (UP) and facilitates the grading and attribution with the Study Investigator and reports both internally and externally according to study specific guidelines

Skills:

data management, clinical data management, edc, clinical data, data collection, clinical trial, clinical research, oncology, Patient recruitment, Regulatory

Additional Skills & Qualifications:

1. Bachelor’s degree and the equivalent of one (1) year of full-time acute care or clinical research experience; or

2. Associate’s degree and the equivalent of two (2) years of full-time acute care or clinical research experience.

Experience Level:

Entry Level