Therapeutic Interventional Senior Clinical Research Assistant

We are seeking a highly motivated detail oriented TI (therapeutic interventional) Senior Clinical Research Assistant/ TI Clinical Research Assistant.

Therapeutic Intervention trials are treatment studies that involve people who have a disease or underlying condition. They include the administration and testing new treatments or new ways of using existing treatments such as new: Drugs Vaccines Cell Therapies Devices Experimental approaches to surgery or radiation therapy.

TI Senior Clinical Research Assistant/ TI Clinical Research Assistant is responsible for the overall management of OHSU Urologys clinical trial alongside the PI and research leadership. This includes working with the regulatory management team to complete regulatory documentation required by the OHSU IRB and sponsor creation of study calendars and flow charts assisting in the verification of patient eligibility development of data collection instruments and consent forms data entry assurance of conduct of protocol in accordance with applicable NCI and FDA guidelines maintenance of study patient records and source documentation coordinating orders and study drug with the clinical team. The TI Senior Clinical Research Assistant/ TI Clinical Research Assistant will have direct patient contact process biological samples and may perform other non-invasive testing such as ECGs. The TI Senior Clinical Research Assistant/ TI Clinical Research Assistant will also assist in the continuing education of physicians residents interns nurses and other related personnel with regards to knowledge of clinical trials and activities.

The TI Senior Clinical Research Assistant/ TI Clinical Research Assistant will operate under supervision of the Urology research manager and will work closely with urology providers in clinical areas such as urologic oncology urinary stone disease fertility voiding dysfunction pediatric urology and laboratory staff at OHSU.

The Department of Urology are committed to increasing the diversity of the campus community. We are dedicated to promoting inclusion and multiculturalism to build a successful organization by having outstanding researchers of diverse backgrounds work together.

Every Urology Research employee is expected to embody Knight Cancers guiding principles:

• We act BOLDLYBreakthroughs require pushing the boundaries of science exploring new frontiers and thinking differently
• We SUPPORT each otherRespect leads to trust which leads to excellence
• We work as a CONNECTED team We must leverage our collective brain power to conquer cancer because no one individual can do it alone

Clinical Trial coordination:

• a) Involved in the conduct of therapeutic interventional human participants research; the development and/or management of regulatory compliance with clinical research protocols. Work with regulatory management team to adhere to regulations at OHSU for initial and continuing regulatory approval of clinical protocols such as annual re-approval/continuing review amendment approval; and submission of reportable information.
• b) Be knowledgeable about clinical research protocols and protocol requirements involving therapeutic interventional studies.
• c) Distribute clinical research related information to appropriate research team / affiliated institutional personnel as applicable. Notify research team and those individuals directly involved in in pertinent areas of clinical research of protocol amendments revisions activations closures and announcements.
• d) Keep local Principal Investigator up to date on key information as related to the clinical research. Schedule and maintain records on appropriate trainings/meetings as needed.

Participant Coordination:

• a) Review patient data to determine appropriate eligibility and deficiencies regarding enrollment into clinical trials.
• b) Confirm with investigator that subject meets appropriate inclusion criteria for therapeutic interventional clinical trial. Communicate all pre-treatment requirements to investigator/clinical staff.
• c) Procure and process human biological specimens (to include blood urine etc.) in adherence with protocol parameters and appropriate training. Obtain and submit imaging studies pathology samples as required by sponsor to appropriate reviewers as required by protocol. Obtain and submit Review and report adverse events or Unanticipated Problems to IRB/study sponsor.
• d) Perform data entry and chart review/abstraction to verify that key data has been reported to the clinical research database or reported to the sponsor in the required format. Review follow up data clarifications or data queries and report within study timeline. Maintain and update subject data for study analysis and survival. Assist investigators with any special requests for data retrieval and/or evaluation and analysis of clinical data for ongoing research studies.

Education: Participate in continuing education activities within the research program and other areas to maintain current knowledge of disease process research regulatory requirements and process improvements for clinical trials.

Additional duties: Additional duties as assigned by OHSU Urology Research Manager.

• Bachelors Degree in relevant field AND 1 year of relevant experience OR
• Associates AND 3 years of relevant experience OR
• 4 years of relevant experience OR
• Equivalent combination of training and experience
• Ability to prioritize multiple tasks at one time
• Excellent communication analytical and organizational skills: both written and verbal
• Ability to work independently and as part of a team while being
  collaborative in resolving problems
• Excellent customer service both on the phone and in person
• Energy and drive to coordinate multiple projects simultaneously
• Ability to use tact and diplomacy to maintain effective working relationships
• Keen attention to detail
• Strong trouble shooting skills

• Some clinical trial knowledge with 1 year of research experience
• Experience with Microsoft Office Access and other networking and database systems
• Experience with medical terminology
• CCRP or ACRP Certified

• Must be able to travel to multiple worksite locations on campus including using the tram
• Coordinator will work with human biological samples including samples which may contain infectious disease
• Coordinator will be expected to travel to conferences new study meetings and may travel for study monitoring at other sites
• Position will require occasional weekend work and ability to focus in a busy cubicle environment with multiple distractions