Subject Management: Identify potential subjects through chart review, discussion with investigator or other mechanisms; assists PI in the identification and eligibility of new protocol subjects; schedules, orders, communicates assessments and appointments with assistance as needed; assists with clinical trial consenting process and ensures accurate completion of appropriate forms and source documentation.
Protocol Management: Assists with feasibility evaluation for new trials; performs pre-screening and enrollment supporting activities as appropriate with assistance as needed; communicates with regulatory PM to ensure approvals are in place; works with study monitors to ensure compliance and quality with assistance as needed; ensures adherence to protocol and regulations.
Study Set Up: Develop new study-specific processes, assists with ensuring everything is in place for the first subject enrollment.
Documentation: Document in research charts or medical record as appropriate with assistance as needed; reviews patient questionnaires for completeness with assistance as needed.
Specimen Processing: Train in basic phlebotomy, be willing to handle and process blood and urine specimens and ship specimens appropriately.
Visual Function Testing: Conduct tests of visual function on clinical trial participants according to protocol including best-corrected visual acuity, visual fields, electrophysiology, measure eye pressure, administer eye drops, imaging of the retina and processing the images.
Communication: Ensures all internal parties are aware of required study activities to include: investigators, study participants, research teams, ancillary services; Facilitates effective communication with sponsor for resolution of questions and issues, enrollment reports, SAE/UP reporting; may facilitate team meetings; involvement in setting meeting agenda.
Data management: May assist with basic elements of CRF development with assistance as needed. May assist with collection and transcription of all source data into study databases and Case Report Forms in a timely and high quality manner.
Regulatory: Regulatory submissions to include RNI, protocol deviations, may assist or participate with other regulatory requirements at the request of the manager with assistance as needed.
This position description may not include all duties of this position and additional duties may be added at the direction of Catherine Schlechter and Mark Pennesi, MD, PhD.
Compliance expectation: Performs requirements for Staff Members as outlined in Compliance Roles and Responsibilities in OHSU Hospitals and Clinics. Carry out job responsibilities in an ethical, effective, and professional manner. Report potential compliance problems using the reporting processes as outlined in the Code of Conduct. Model ethical and appropriate behavior, professional standards, compliance, and personal integrity. Understand and comply with the Code of Conduct, OHSU and departmental policies and procedures, applicable rules, regulations, etc. Documents in medical record all patient care services delivered in support of third party bills. Processes billings for hospital and clinic charges in accordance with HCFA, Medicaid, Champus and all commercial and managed care carriers. Assures departmental compliance with all applicable third party payer regulations and contracts. Adheres to all Casey Eye Institute Service Excellence standards and expectations and attends all related mandatory training programs.
As the state's only health and research university, OHSU brings together patient care, research, education of the next generation of health care providers and scientists and community service to improve the health and well-being of all Oregonians.The university is a conduit for learning for more than 2,800 students, providing training to interns, residents and fellows in postgraduate medical and research. It is the only place in Oregon that grants doctoral degrees in medicine, dentistry and nursing. OHSU cares for more than 251,000 patients each year from around the region and takes a leadership role in contributing to solutions involving the health of the state and the nation, such as health care access and transparency, ethics and workforce shortage. Beyond providing critical health care services, quality education and cutting-edge research, OHSU also is a key economic and social force in the Northwest. With an annual operating budget of $2.06 billion and more than 14,000 employees, OHSU is Portland?s largest employer. Its size contributes to its ability to provide... many services and community support activities not found anywhere else in Oregon. For more information visit http://www.ohsu.edu/xd/about/index.cfm