Providence Health & Services Coordinator, Clinical Research Regulatory 1 in Portland, Oregon
Providence is calling a Coordinator-Clinical Research Regulatory 1 - Medical Research (1.0 FTE, Days) to Providence Portland Medical Center in Portland, OR
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We are seeking a Coordinator-Clinical Research Regulatory 1 - Medical Research that will function under the supervision of the Regional Research Regulatory Manager, coordinating and maintaining regulatory activities related to the various types of research studies conducted at PH&S Research Programs. This includes, but is not limited to writing or revising study-related documents to be submitted to IRB or other regulatory bodies, preparation and maintenance of regulatory documents, the use and upkeep of the Clinical Trial Management system, and implementation of regulatory systems and processes. Interacts closely with institutional investigators, industry sponsors, cooperative group operations offices, and research programs. Collaborates with the Clinical Research Team members throughout study completion.
In this position you will have the following responsibilities:
Develop and maintain in-depth knowledge of the standards and policies governing the conduct of clinical studies and the involvement of human subjects, including Federal, state and local government regulations, as well as institutional and departmental policies and procedures
Work with research programs to prepares IRB submission for new studies within the required IRB timelines
Coordinate the regulatory process for the IRB processing of protocol modifications and amendments, consent changes, continuing reviews, serious adverse events, protocol variances, safety reports and Investigator Brochures through the Institutional Review Board (IRB)
Enter and update regulatory-related milestones in the Clinical Trials Management software in an accurate and timely manner
Collaborate with research programs and investigators to assure consent changes and consent addendums regarding protocol amendment or newly identified risks are communicated to the study participant in a timely and appropriate format
Ensure all study-related regulatory documents are maintained in a complete and organized manner
Coordinate the regulatory preparation for audit and monitoring visits ensuring that this is carried out in an organized manner
Demonstrate excellent verbal and written communication skills with internal and external personnel in coordinating regulatory process for clinical studies
Required qualifications for this position includes:
Bachelor's Degree with courses in public health, community program development, psychology/sociology, and research -OR- equivalent education/experience
Two (2) years of experience with medical terminology or clinical research
Basic understanding of the regulations governing clinical research (CFR, GCP, ICH, HIPAA)
Familiarity with OHRP guidelines
Proficiency in Microsoft Office Suite (mainly Word, OneNote, and Excel), Internet applications, Adobe Acrobat, and Outlook e-mail
Preferred qualifications for this position include:
- Six (6) months of experience with IRB submissions
About Providence in Oregon
As the largest healthcare system and largest private employer in Oregon, Providence offers exceptional work environments and unparalleled career opportunities.
The Providence Experience begins each time our patients or their families have an encounter with a Providence team member and continues throughout their visit or stay. Whether you provide direct or indirect patient care, we want our patients to feel that they are in a welcoming place where they can be comfortable and free from anxiety. Our employees create the Providence Experience through simple, caring behaviors such as acknowledging and welcoming each visitor, introducing ourselves and Providence, addressing people by name, providing the duration of estimated wait times and updating frequently if timelines change, explaining situations in a way that puts patients at ease, carefully listening to their concerns, and always thanking people for trusting Providence for their healthcare needs. At Providence, our quality vision is simple,
"Providence will provide the best care and service to every person, every time."
Providence is consistently ranked among the top 100 companies to work for in Oregon. It is also home to two of our award-winning Magnet medical centers. Providence hospitals and clinics are located in numerous areas, ranging from the Columbia Gorge to the wine country to sunny southern Oregon to charming coastal communities to the urban setting of Portland. If you want a vibrant lifestyle while working with a team highly committed to the art of healing, choose from our many options in Oregon.
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As expressions of God’s healing love, witnessed through the ministry of Jesus, we are steadfast in serving all, especially those who are poor and vulnerable.
Providence is a comprehensive not-for-profit network of hospitals, care centers, health plans, physicians, clinics, home health care and services continuing a more than 100-year tradition of serving the poor and vulnerable. Providence is proud to be an Equal Opportunity Employer. Providence does not discriminate on the basis of race, color, gender, disability, veteran, military status, religion, age, creed, national origin, sexual identity or expression, sexual orientation, marital status, genetic information, or any other basis prohibited by local, state, or federal law.
Job Category: Research
Req ID: 331279