The TI Clinical Research Assistant II hired for this position will effectively and efficiently support the development and implementation of clinical research studies in the Department of Anesthesiology & Perioperative Medicine. These studies will include Therapeutic Intervention Trials which involve people who have a disease or underlying condition.  Trials could include the administration and testing of new treatments or new ways of using existing treatments which could include drugs, vaccines, cell therapies, devices, or experimental approaches to surgery or radiation therapy.  Duties in this position will include conducting study initiation, implementation and close out activities, which includes: patient recruitment and consenting, coordinating study and conducting study procedures, assisting in maintaining records and collection of study data, preparing for site monitoring visits, and ensuring studies are maintained and conducted in accordance regulatory requirements. This position also serves as a point of contact with industry sponsors and Principal Investigators (PIs) to ensure successful execution of clinical research studies.

Therapeutic Intervention Clinical trial coordination:

• For therapeutic intervention trials: coordinate patient recruitment/enrollment into studies.  This involves: telephone screen potential subjects or recruit subjects in clinic or hospital, obtain informed consent from study participants or surrogates, schedule research participants for screening visits and follow-up visits, and coordinate scheduling of any additional procedures or consults;
• Triage and appropriate escalation of study related concerns for therapeutic intervention trials;
• Execute other tasks as required to maintain therapeutic intervention trial protocols.  This includes, preparation of study subject lab specimens for shipment, point of care testing (i.e. neuro-psych testing), administer questionnaires, maintain study records, and other duties as needed.

Therapeutic Intervention Clinical Trial Study Administration:

• Collect and accurately enter data for therapeutic intervention trials in study databases;
• Complete sponsor case report forms or enter data into electronic data capture system for therapeutic intervention trials;
• Respond to data queries and conduct visits for therapeutic intervention trials with study monitors, including site qualification visits, site initiation visits, and periodic monitoring visits; 
• Maintain study records in eCRIS for therapeutic intervention trials;
• For therapeutic intervention trials: ensure all project deliverables meet sponsor and departmental expectations, as well as meet standards of ICH/GCP.

 

Therapeutic Intervention Clinical Trial Set-Up/Closure:

• Assist regulatory specialist in preparing eCRIS and IRB submissions for therapeutic intervention trials initial review, including modifications, continuing review, and termination;
• For therapeutic intervention clinical trials: assist in developing source documents, questionnaires, data collection forms, and databases as required by protocol;
• For therapeutic intervention clinical trials: assist in developing subject recruitment materials (e.g., advertisements, flyers, letters) and implement recruitment plan.

Education:

• Bachelor's in relevant field OR
• Associate's AND 2 years of relevant experience OR
• 3 years of relevant experience OR
• Equivalent combination of training and experience

Experience:

• No experience OR
• 2 years with AA degree

Job Related Knowledge, Skills and Abilities (Competencies):

• Demonstrated computer proficiency with MS Office Suite including Word, Excel (including spreadsheet creation and maintenance mastery), Outlook, and Powerpoint.
• Keyboarding proficiency and accuracy.
• Exceptional communication skills and organizational skills.
• Detail oriented and committed to follow through.
• High level of initiative with the ability to work independently.
• Ability to exercise sound judgment in making decisions or dealing with unusual situations.
• Exemplary communication skills over the phone, face to face, and written are required.
• Outstanding interpersonal skills to interact professionally with faculty, staff, and all levels of management.
• Must have demonstrable record of reliable attendance, punctuality, and proven successful performance at past and present employers.

Compliance:

• Code of conduct
•  Respect in the workplace
• Applicable policies, procedures and agreements related to position, department or OHSU as a whole

Education:

• Bachelor’s or Master Degree

Experience:

• 1 year of relevant experience preferred

Job Related Knowledge, Skills and Abilities (Competencies):

• RedCAP
• eIRB
• eCRIS
• EndNote
• Adobe

Registrations, Certifications and/or Licenses:

• ACRP or SoCRA certification

The employee hired for this position will need to be able to work a full-time schedule on-site on the OHSU campus, there is no opportunity for remote work.  Due to the unpredictability of research activities, hours may have to be shifted to accommodate research patients and data collection.  In particular, there may occasionally be a need to arrive as early as 6:00 a.m. or stay later than 5:00 PM should study tasks require.  Intermittent weekend work may be required.  Work locations will include the Peri-Anesthesia Care Units and operating rooms in UHS and UHN, the Comprehensive Pain Clinic in the Center for Health and Healing, and office work in Multnomah Pavilion.

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.