TI Sr Clinical Research Assistant

Department Overview

As a TI Sr Clinical Research Assistant, this individual is responsible for clinical, administrative, and educational research activities related to the management of patients on clinical trials of the MFM Research Unit. This position is responsible for assisting with mentorship and training of new and existing Research Assistants in MFMRU as their positions relate to coordination of clinical trials. The appointee shall provide services as assigned by the supervisor in furtherance of the university’s missions and goals of teaching, research, patient care, outreach and public service. Appointee will participate in the on call schedule including intermittent evening, weekend, and holiday coverage. Position may require travel to off-site partnership locations around the state of Oregon.  

Function/Duties of Position

1.  Clinical Trials Management 

• Supervision of pregnancy related clinical research trials at OHSU and other affiliated hospitals including screening of potential participants, maintenance and submission of patient data, evaluation of protocol activities, maintenance and preparation for quality assurance audits and management of investigational drugs distribution. 
• Requires strong understanding of research protocols and regulations.
• Assistance with pre-study tasks including feasibility questionnaires and site qualification visits.

2.  Patient Contact

• Responsible for patient interactions as outlined in protocol and as delegated by Principal Investigator.
• Perform participant interviews and physical measurements, including but not limited to blood pressure, heart and respiratory rates, and specimen collection(s).

3.  Regulatory Compliance & Administrative

• Study regulatory documents maintenance 
• Assist with literature reviews,
• Assist in marketing or advertising outreach efforts as assigned and supervised by unit manager. 

4.  Data Management and Abstraction

• Maintenance and submission of patient data and preparation for quality assurance audits and monitoring.
• Data abstraction for MFM databases and all assigned studies. 
• Data management on assigned studies including REDCap.
• Data entry

5.  Training and Mentorship

• Conduct clinical research training for MFMRU study coordinators and volunteers. Develop Training Manuals, Training Schedules/Agendas/Assignments. Ensure adequate cross-training for assigned duties.
• Provide mentorship for junior level MFMRU study coordinators.
• Participates in the development of new policies and procedures for clinical research unit in collaboration with MFMRU Leadership
• Participate in interviewing and hiring of MFMRU study coordinators.
• Provide feedback to MFMRU Leadership on performance measures and productivity targets to promote job satisfaction for MFMRU staff.

Required Qualifications

• Bachelor’s Degree in relevant field AND 1 year of clinical research coordination experience OR
• Associate’s Degree AND 3 years of relevant field OR
• 4 years of relevant experience OR
• Equivalent combination of training and experience

Preferred Qualifications

• Clinical Trials experience strongly preferred.
• Women’s Health specific experience is preferred.
• 3-5 years research experience preferred.
• Spanish speaking preferred.
• Previous work with physicians in an academic environment.

Additional Details

Please provide a cover letter and resume/cv.

All are welcome

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. As an organization devoted to the health and well-being of people in Oregon and beyond, OHSU requires its employees to be fully vaccinated against COVID-19.