TI Senior Clinical Research Assistant at Oregon Health & Science University in Portland, Oregon

Job Description:

Oregon Health & Science University

Oregon Health & Science University values a diverse and culturally competent workforce. We are proud of our commitment to being an equal opportunity, affirmative action organization that does not discriminate against applicants on the basis of any protected class status, including disability status and protected veteran status. Individuals with diverse backgrounds and those who promote diversity and a culture of inclusion are encouraged to apply. To request reasonable accommodation contact the Affirmative Action and Equal Opportunity Department at 503-494-5148 or aaeo@ohsu.edu.


TI Senior Clinical Research Assistant

US-OR-Portland

Job ID: 2025-33624
Type: Regular Full-Time
# of Openings: 1
Category: Research
Portland, OR (Marquam Hill)

Overview

Subject Management: Assist with pre-screening and identification of potential subjects through chart review, investigator communications, or other mechanisms (e.g., KCI disease site meetings, tumor boards, patient/physician inquiries); Assist with verification and documentation of eligibility; Ensure that current, approved consent form is used during informed consent, consent is signed/dated prior to patient starting any study activities, and consent process is followed as per department SOP; Complete study entry and visits in OHSU’s clinical trials management system (CTMS); Enter orders in EPIC and route to investigator for approval; Communicate with scheduling departments, patients, and other team members to coordinate study visits; Review subject source documents (e.g., labs, imaging reports, visit notes) and alert investigators to questionable results; Collect, process, and ship patient biospecimens (e.g., blood, urine, tissue, or CSF) in compliance with OSHA lab safety requirements, IATA standards, and protocol/lab manual guidelines; Develop clear, written communications for study participants and study team to ensure protocol compliance and accurate data collection; Serve as point of contact for subject to raise questions and/or concerns, resolving issues in a timely manner and in coordination with the study team, research manager, investigators, and/or OHSU’s Integrity Department.

Study Startup, Conduct, and Closeout: Assist in the development of study-specific processes and workflow, including coordinating within radiology and with other OHSU areas (e.g. pharmacy, clinics, KCI disease teams); Assist with ensuring everything is in place for the first subject enrollment, such as regulatory documents and case report forms (CRFs) for new and ongoing studies (informed consent, recruiting materials, eligibility checklists, etc.); Facilitate subject visits and ensure all research staff are conducting assessments per study protocol (TI SCRA to perform assessments when applicable); Assist with visit schedule entry in OHSU’s CTMS; Ensure all internal parties are aware of the study schedule/workflow and have access to data collection tools (e.g., investigators, study participants, research teams, ancillary services, and others); Inform sponsors, clinical research organizations, and central/local IRBs of SAE/UP and/or protocol deviations; Assist finance team members by ensuring that study billing is accurate and verifying that visit and other study activities are complete; Attend/Participate in study team meetings; Assist with team meeting facilitation, agenda drafting, and follow-up notes, as needed; Assist with study closeout activities, including regulatory, billing, and preparations for long-term storage of study documents.

Data Management: Ensure collection and/or transcription of all source data (i.e., progress notes, lab reports, imaging reports, pathology reports) into electronic data capture (EDC) systems and CRFs in a timely and high quality manner; Maintain and securely store study subject binders containing source data as per IRB and HIPAA compliance; Assist trial monitors with query resolution; Work with Radiology’s IT and clinical teams to coordinate the transfer of images, imaging data, and/or reports to sponsors and collaborators as per OHSU’s HIPAA and data sharing policies; May assist with basic elements of CRF development with assistance, as needed.

Documentation: Document subject information, eligibility, consent, subject encounters/visits, AE/SAE/UP, in research charts, case report forms (CRF), electronic medical record (EMR); and electronic data capture system (EDC); Review patient and clinic questionnaires for completeness.

 

Regulatory Compliance: Assist and work with DR Regulatory Project Manager to maintain and document regulatory approvals for clinical protocols per compliance requirements at OHSU, such as initial & annual reviews, amendment approval, and submission of reportable new information (RNI); Assist senior research staff with maintenance and submission of patient data and preparation for quality assurance audits and monitoring; Assist in preparation for inspections from Federal regulatory agencies; Assist investigators with oversight activities by exercising judgment within defined GCP and HIPAA guidelines to determine appropriate action via reporting mechanisms and structures (Institutional Review Board) in recognizing adverse events, protocol deviations, and other unanticipated study problems and reports to senior staff appropriately. 

Protocol Management: Communicate with study team to ensure that regulatory approvals are in place; Prepare for study monitoring visit and work with monitors to ensure compliance and quality with assistance, as needed; Ensure adherence to protocol and regulations; communicate with study sponsors and/or CROs regarding study implementation and inquiries. May assist leadership across multiple protocols to ensure appropriate and consistent project management, complex logistics, quality assurance, and participant safety; Review and execute on each protocol assigned as it pertains to the TI SCRA role.

Education: Participate in study-specific trainings. Participate in continuing education activities to maintain current knowledge of regulatory requirements, process improvements for clinical trials, and research operations and responsible conduct of research at OHSU; Review and reference department policies, standard operating procedures (SOP), and work instructions (WI) at training and ongoing during study conduct. 

Additional Duties: Assist with manuscript development, Assist with data collection via Epic and Enterprise Imaging searches, Assist with database builds; and Additional duties as assigned by leadership. 

Responsibilities

• Bachelor’s degree in a relevant field
• 1 to 3 years of experience contributing to the effective conduct of clinical trials
• Ability to learn web-based databases quickly
• Excellent analytical, organizational, and communication skills (both written & verbal)
• Ability to work independently and as part of a team while being collaborative in resolving problems
• Ability to prioritize work demands and manage time appropriately
• Ability to meet deadlines while juggling multiple projects, urgent patient needs, and/or system issues
• Must have demonstrated excellent customer services skills on the phone, via email, and in person
• Ability to use tact and diplomacy to maintain effective working relationships
• Proficiency with computers that run Windows and PC applications, i.e., Microsoft Word, Excel, Outlook, and PowerPoint
• Must possess the energy and drive to coordinate multiple projects simultaneously
• Must have demonstrated record of reliable attendance, punctuality, and proven successful performance

Qualifications

• Previous experience with electronic data capture (EDC) systems
• Previous experience with cloud-based data storage solutions.
• Knowledge of medical terminology
• Previous experience with EPIC
• Previous experience in a patient-facing or customer-facing role
• CCRP or ACRP Certified

Equal employment opportunity, including veterans and individuals with disabilities.

PI265993929

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