TI Clinical Research Associate

Department Overview

Therapeutic Intervention Clinical Research Associate position in the Parkinson Center and Movement Disorders Division, Department of Neurology. Responsible for completing the study start-up activities for clinical trials, in collaboration with the Research Administrator. Provides leadership, training, and guidance to junior research assistants through written and in person instruction. Serves as lead study coordinator on assigned clinical trials. Supports Research Administrator, Administrative Director, and Center Director in tasks related to clinical trials and the research assistant team.

Study start-up
:
In collaboration with Research Administrator, responsible for all components of clinical research trial start up for Movement Disorders. Includes completing feasibility questionnaires and site selection visits (on site or remote), facilitating completion of confidentiality disclosures, central and local IRB submissions, OnCore setup, coordination of services with other internal and external departments and vendors, and coordinating and attending site initiation visits.

Study Coordination
:
With occasional supervision, coordinate and conduct complex study visits involving multiple staff and hospital services, including but not limited to – recruitment, scheduling, obtaining informed consent; lab sample collection and processing, conducting and/or assisting with study procedures (vital signs, ECGs, lumbar punctures, & skin punch biopsies), data entry, and regulatory document submission to central and local IRBs. Effective and professional communication (written/electronic and verbal) with study team, study participants, sponsors, contract research organizations (CRO), investigators, Institutional Review Boards (IRBs), and other departments paration for and coordination of external monitoring visits.

Lead & Train
:
In collaboration with Research Administrator, onboard, train, and advise junior research assistants, create and maintain written training materials for research team, review and revise Standard Operating Procedures (SOPs), serve as point of contact for all research assistants and investigators with questions and concerns related to clinical trials and regulatory requirements.

Education & Communication
:
Attend weekly meeting with Research Administrator, lead weekly research team meeting, participate in monthly research meeting with Center Director, monitor changes to university and industry standards for clinical trial compliance.

Additional Support
:
Support Research Administrator in tasks related to clinical trial operations and research team, including hiring, clinical trial invoicing, and other duties as assigned.

• Master’s degree in relevant field AND 3 years of clinical research coordination experience OR; Bachelor’s degree in relevant field AND 5 years of clinical research coordination experience
• Clinical research coordination, including primary responsibility for multiple complex clinical trials and regulatory document maintenance, in role(s) with minimal oversight
• Experience using electronic medical records system(s)
• Experience with independent IRB submissions (initial submissions, modifications, &/or annual review)
• Clinical skills, such as specimen processing, ECG, & vital signs measurements
• Knowledge of clinical research regulatory standards and guidelines
• Extremely well-organized with high attention to detail
• Able to efficiently manage multiple tasks and demands with competing deadlines
• A self-starter, able to work independently while being effective and efficient
• Excellent written and verbal communication skills
• Enjoys collaborating with and supporting colleagues in a team environment
• SOCRA (Society of Clinical Research Associates) or ACRP (Association of Clinical Research Professionals) certification required within 12 months of hire

• Experience using the Epic medical record system
• Familiarity with procedures of the OHSU Institutional Review Board
• Phlebotomy certification, or a desire to obtain one within 3 months of hire
• Experience working with a senior population
• Completion of CITI (Collaborative…