TI Clinical Research Associate Job at Oregon Health & Science University, Portland, OR

V0hpSExHL25yK0FuV3hzY2xPRWEzNzV5S3c9PQ==
  • Oregon Health & Science University
  • Portland, OR

Job Description

Join to apply for the TI Clinical Research Associate role at Oregon Health & Science University Continue with Google Continue with Google 16 hours ago Be among the first 25 applicants Join to apply for the TI Clinical Research Associate role at Oregon Health & Science University Department Overview The TI Clinical Research Associate works directly under a principal investigator and/or Research Manager/Director. Involved in the conduct of Therapeutic interventional human participants research; the development and/or management of regulatory compliance with clinical research protocols. Screens, enrolls, recruits, and retains research participants. Coordinates study visits, research schedules, obtain consent, blood draws, sample collections, monitors research activities, participation, etc. Collaborates with various OHSU departments to operationalize research protocols. Ensures appropriate charge designation for clinical research billing. Department Overview The TI Clinical Research Associate works directly under a principal investigator and/or Research Manager/Director. Involved in the conduct of Therapeutic interventional human participants research; the development and/or management of regulatory compliance with clinical research protocols. Screens, enrolls, recruits, and retains research participants. Coordinates study visits, research schedules, obtain consent, blood draws, sample collections, monitors research activities, participation, etc. Collaborates with various OHSU departments to operationalize research protocols. Ensures appropriate charge designation for clinical research billing. Therapeutic Intervention trials will be related to type 1 and type 2 diabetes. Protocols involve understanding the causes and nature of diabetes in the human body, the characteristics of diabetes, and developing/testing new drugs and/or devices for the management and treatment of diabetes. Function/Duties of Position Key Responsibilities & Performance Standards Conducting duties for clinical studies involve recruiting and screening subjects, managing study supplies, prepping devices for studies, scheduling and running of study visits, handling of subject samples and preparing for lab analysis, performing data analysis of study data, and attending staff meetings. Collaborating on duties for device development involve assisting engineers and clinicians in device validation testing and assisting in preparation of FDA applications. This entails working extensively with diabetes technology and our custom smart phone diabetes management software applications. Under occasional supervision, coordinates complex, multi-center therapeutic interventional clinical research protocols/programs and data management. Contributes to research and assists with study protocol development. Ensures research protocol implementation, meeting expectations, timelines, and deliverables. Assist with budget development, billing review and charge reconciliation. Tracks and reports milestones for proper billing and payment. Collaborates with various internal and external entities to complete required protocol testing and procedures. Oversees, educates and serves as an expert resource for other clinical research coordinators. Assigns and monitors tasks and their completion. Participates in training and onboarding new staff. Maintenance and submission of patient data and preparation for quality assurance audits and monitoring. Assist in preparation for inspections from Federal regulatory agencies. Data management on studies. Exercises judgment within defined Good Clinical Practice (GCP) and HIPAA guidelines to determine appropriate action via reporting mechanisms and structures in addressing adverse events as appropriate, protocol deviations, and other unanticipated study problems. Required Qualifications Master’s degree in relevant field AND 3 years of clinical research coordination experience OR Bachelor’s degree in relevant field AND 5 years of clinical research coordination experience. Preferred Qualifications Strong organizational skills and attention to detail. Demonstrated ability to take initiative and complete projects independently. Excellent communication, both written and verbal, with fluency in English. Strong computer skills and advanced MS Office skills. Experience with database management. Knowledge of institutional review board (IRB) processes for submitting, modifying, terminating and continuing review of human protocols Understanding of best practices for clinical research. Project management skills Experience with interventional clinical trials Working knowledge of FDA IDE/IND submission process, eCRIS, and OHSU eIRB. Familiarity with electronic medical records (preferably EPIC), chart review, and medical terminology. Ability to navigate research site visits with industry sponsors, in-depth knowledge of budget development and clinical trial review. BLS certification, Training in phlebotomy Additional Details Exposure to human fluids. Work week schedule requires flexibility in evenings and possibly overnight monitoring to meet demands of research patient visit schedules. 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. Seniority level Seniority level Not Applicable Employment type Employment type Full-time Job function Job function Research, Analyst, and Information Technology Industries Hospitals and Health Care Referrals increase your chances of interviewing at Oregon Health & Science University by 2x Sign in to set job alerts for “Clinical Research Associate” roles. Continue with Google Continue with Google Continue with Google Continue with Google Clinical Research Assistant 2 -OR- Clinical Research Assistant 1 Research Assistant 1 -OR- Research Assistant 2 We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr Oregon Health & Science University

Job Tags

Full time, 16 hours, Night shift, Afternoon shift,

Similar Jobs

Quigley House

Sexual Assault Services Coordinator Job at Quigley House

 ...Job Description Job Description Benefits: ~401(k)~ Health insurance ~ Paid time off ~ Training & development ~ Vision insurance Responsible for the management of the Sexual Assault Center, including the forensic examination program, helpline, sexual... 

VIA Metro Transit

Bus Operator Part Time (San Antonio) Job at VIA Metro Transit

 ...safety-conscious individuals to join our team of Bus Operators Part Time! This isnt just a job; its an opportunity to connect with...  ...to detail. Additional Perks: Diverse Schedule Options: Early mornings, late nights, weekends, or holidays. Supportive Culture: Join... 

Banfield

vet assistant Job at Banfield

 ...The Veterinary Assistant supports the veterinarians and veterinary technicians in ensuring quality veterinary care for all pets, advocates for pets, educates clients on all aspects of pet health, and ensures a safe and effective hospital environment. Assistant, Hospital... 

CI Health Group, LLC

Pediatric Hospitalist Physician (Town of Gates) Job at CI Health Group, LLC

 ...Pediatric Hospitalist Physician at CI Health Group, LLC - Summary: The Pediatric Hospitalist Physician role involves managing pediatric patients in a hospital setting with a 7-on, 7-off schedule. Responsibilities include attending C-sections and high-risk deliveries.... 

Domino's

Delivery Driver (04253) - $13 / HR + Cash Tips Daily + Mileage Job at Domino's

 ...responsible for delivering food to customers with excellent customer service and a positive attitude. Why deliver for us: Great pay- Daily cash tips + $13 / HR Benefits - All team members are eligible for benefits (eligibility for certain benefits dependent on...