Clinical Research Associate

Function/Duties of Position

The Clinical Coordinator works directly under a directors for the Center for Embryonic Cell & Gene Therapy (CECGT) Principal Investigators (PI) and/or Research Manager and will be responsible: for the conduct of clinical research with human participants; the development and/or management of regulatory compliance with clinical research protocols; screening, enrollment, recruitment, consenting, financial compensations and retention of all research participants for the CECGT. Coordinates study visits, research schedules, obtain consent, blood draws, sample collections, monitors research activities, participation, assists with all clinical projects and national and international clinical trials and all regulatory processes. The OHSU CECGT http://www.ohsu.edu/xd/research/centers-institutes/embryonic-cell-gene-therapy-center/) reports to the Chief Research Officer and is a critical scientific and clinical research center at OHSU with specific focus on human gamete, embryo and embryonic stem cell research.

The Clinical Coordinator represents the Center at various OHSU groups and task forces and must operate with great accuracy and efficiency. Under the supervision of the Center Director, the Clinical Coordinator interacts with research leadership, administration, and IRB and provides clinical research support for faculty, staff and collaborators.

This position oversees all compliances with internal and external regulatory agencies for clinical research, and prepares protocols and manages regulatory compliance documentation for IRB, FDA, IND, SRC, IRAP, DSMC committees. This position serves as the regulatory liaison between the director and all monitoring entities. A successful Clinical Coordinator will have and maintain a working knowledge of FDA, DHHS, international law, and other agency guidelines that govern clinical research globally.

Overall, the Clinical Coordinator promotes the mission of the Center for Embryonic Cell and Gene Therapy by exhibiting reliability, productivity, professionalism, accuracy, timeliness, problem-solving, strong ethical understanding of our complex scientific focus, strong legislative focus and understanding of current congressional legislation, as well as compassion and kindness when communicating with research participants, outside organizations, and OHSU doctors and staff including physicians, nurses, and medical assistants.

Required Qualifications

• Bachelor's Degree in related field AND 5 years of clinical research coordination experience OR

• Master's degree in relevant field AND 3 years of clinical research coordination experience.

• Minimum of 3 years' related experience in clinical research and recruitment.

• Excellent interpersonal skills, with ability to deal credibly and effectively with all levels of internal and external audiences (senior institutional leadership, global collaborators, employees, patients, students and volunteers).

• Working knowledge of fertility concepts

• Strong organizational skills, ability to manage highly detailed projects

• Excellent communication (written and oral)

• Attention to detail, strong understanding of scientific method, and critical judgment skills

• Ability to effectively identify and resolve issues and concerns, interacting in a manner that demonstrates sensitivity, tact, professionalism and discretion

Preferred Qualifications

• Master's degree in relevant field AND 3 years of clinical research coordination experience.

• Previous experience in clinical research coorsination with study subjects in women health, gamete and/or embryo donations. Ability to communicate on a lay-person level to obtain true informed consent.

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.