Clinical Research Assistant

The US Oncology Network•Roanoke, VA

6h•Onsite

About The Position

The Clinical Research Assistant is responsible for recruiting, screening, consenting, and enrolling patients in clinical trials. The Clinical Research Assistant also coordinates and oversees the subject’s visits in accordance with the protocol requirements. Duties include but are not limited to assuring protocol compliance for all patients enrolled in the trial, participation in the informed consent process, performing ongoing assessments and documentation in collaboration with physicians and other providers. Acts as a resource for the education and training of clinic staff as well as a resource for problem-solving of complex issues for the implementation of the research process throughout the clinic, process improvements, and SOPs. Compiles and reports protocol activity, accrual data, and financial information. Assures site research quality by practicing in compliance with "The Network" Standard Operating Procedures (SOP), principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations through OSHA, CDC and HIPPA. Supports and adheres to "The Network" Compliance Program, to include the Code of Ethics Business Standards.

Requirements

Associate's degree in a clinical or scientific related discipline required
Minimum three years of experience in a clinical or scientific related discipline required
Experience in Microsoft Office
Must have excellent communication skills
Excellent organizational skills
Strong ability to multi-task
Excellent time management skills
Must have strong interpersonal skills to be able to interact with multiple people on many different levels
Must have a high level of attention to detail
Must be able to work in a fast-paced environment
May be responsible for basic clinical assessments

Nice To Haves

Bachelor's degree preferred
SoCRA or ACRP certification preferred
Experience working with physicians preferred
Experience working in clinical research is preferred

Responsibilities

Screens potential patients for protocol eligibility.
Presents trial concepts and details to the patients, participates in the informed consent process, and enrolls patients on clinical trials.
Coordinates patient care in compliance with protocol requirements.
May disburse investigational drug. Maintains investigational drug accountability.
Oversees the preparation of orders by physicians to assure that protocol compliance is maintained.
Packages and ships lab specimens to central vendors where applicable.
Required to complete Hazmat and/or IATA training.
In collaboration with the physician, reviews patients for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly documents all findings and participates in data collection of all subjects.
Responsible for preparing study-related documentation such as protocol worksheets, adverse event reports, institutional review board documents, and annual continuing review reports.
Maintains regulatory documents in accordance with USOR SOP and applicable regulations.
May participate in scheduling monitoring and auditing visits, as well as interact with the monitors/auditors while onsite.
May collaborate with Research Site Leader in the study selection process.
Participates in required training and education programs.
May be responsible for education of clinic staff regarding clinical research.
Collaborates with staff in the development of action plans and performance improvement opportunities with staff to improve quality.
May be responsible for compiling and reporting protocol activity, accrual trends, data entry compliance, and research financial information to practice administration and physicians.
May be responsible for reviewing protocol specific billing guides and submitting billing information to appropriate personnel.