Department Overview:
The Clinical Trials Unit supports the vision of the Division of Cardiovascular Medicine, the Knight Cardiovascular Institute (KCVI) and OHSU Health to provide Oregonians with state-of-the-art facilities and outstanding staff to advance treatments for cardiovascular diseases. KCVI and OHSU Health proudly collaborate to support clinical research and bring the future of cardiovascular care to the present. Our clinic, located on the South waterfront in CHH1, supports the complex care initiative and the Healthcare mission's priorities, while the CTU provides in patient trial opportunities and procedural care on OHSU main campus as well. Our unit provides the physical infrastructure to perform pharmacological and medical device trials including trials which require infusions, genetic trials, device implants, and cutting-edge imaging.
The Knight Cardiovascular Institute Clinical Research Assistant II (Assistant Coordinator) is responsible for various duties related to clinical trials. They will assist the study coordinators in supporting patient visits, assists in data collection and entry for the sponsor, and coordinates patient travel to ensure study subjects are able to meet their visits. This position will primarily support our Cardiomyopathy research team within the division of Cardiology, they may be reassigned secondary duties to support other sections within the Cardiovascular Medicine Clinical Trials Unit and Knight Cardiovascular Institute. This is an onsite role with limited hybrid opportunities.
Function/Duties of Position:
Always promotes the mission of the Knight Cardiovascular Institute through our Professional Standards of timely Customer Service, Reliability, Productivity, Professionalism, Accuracy, Timeliness, Integrity, and Problem-Solving.
Responsible for many aspects of clinical trial operations from site initiation visit to closeout and assuring appropriate conduct of protocols to meet FDA guidelines. This includes but is not limited to:
Works in collaboration with study coordinator to maintain and file regulatory and study documents of active trials to meet study requirements
Create a weekly task list of outstanding items for review to ensure data entry to EDC is captured within obligatory time frames
Collection and transcription of all laboratory and imaging data with guidance from the coordinator as needed.
Data entry of visit data into central data repositories (eCRIS, internal subject trackers, etc.)
Addressing all imaging and laboratory queries in sponsor ERT
Maintaining laboratory reporting and signature requests from the PI
Responsible for elements of patient visits including but not limited to:
Work with coordinator in planning visit activities and scheduling participant appointments
Take point on patient scheduling
Coordination of patient travel
Prepping any necessary documents prior to the visit
Responsible for communicating with patients regarding scheduled appointments
Work with coordinator in collaborating with ancillary departments to make sure all patients receive timely ECHO’s, Imaging, vitals (blood pressure, temp, respirations, height, weight) or other study related tasks as needed.
Independently provide follow up for subjects who are no longer receiving treatment in the form of phone calls or clinic visits.
Work with monitoring groups to ensure all data is captured as per protocol
Assist the Clinical Trial Leadership, coordinators, or Principal Investigator with other research related projects and administrative/office related duties as needed
Assist manager and coordinator as needed in supporting sponsor visits (i.e. proctoring visits, monitoring, site initiation, etc.)
Required Qualifications:
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
Ability to prioritize multiple tasks at one time
Must have 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.
Must be proficient with computers running Windows and PC applications e.g. MS Excel, Oracle, Access, Word and PowerPoint).
Must have demonstrated excellent customer service skills both on the phone and in person.
Demonstrated ability to work with a variety of diverse individuals and personalities.
Must possess energy and drive to coordinate multiple projects simultaneously.
Ability to use tact and diplomacy to maintain effective working relationships
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Ability to perform the job duties with or without accommodation.
Preferred Qualifications:
- Bachelor's degree with coursework in Science
At least one year general office experience
Knowledge of cardiology. Managing Access database or similar database.
Microsoft office, medical terminology, analytical skills, trouble shooting skills. Ability to work independently as well as within a team environment.
BLS
Additional Details:
Location: Marquam Hill & South Waterfront Campus
Schedule: Monday – Friday, 6am – 6pm primary business hours with variability depending on clinical schedules with occasional evenings & weekend work to meet project deadlines/goals. As a salaried employee assistant coordinators are expected to flex their time in conjunction with OHSU policy; this may mean working more than 40 hours in a week and then less another.
Must be able to travel to all KCVI worksite locations, including potentially using the tram numerous times each day. Will work with human biological samples, including samples which may contain infectious disease. Research assistant Coordinator may be expected to travel to conferences, new study meetings. Clinical Research Assistant Coordinator is required to use Personal Protective Equipment (gloves, masks, etc.) as required to maintain a safe and healthy clinical research environment. Additional safety training may be required to work in clinical research. Position requires ability to focus in a busy cubicle environment with multiple distractions. Position requires successful completion of BLS certification.
This is a patient facing on-site roll. Limited remote work is approved on an as needed basis by Clinical Trial Administrator. All obligations to clinical schedules and security of paper PHI and clinical trials regulations must be maintained at all times – this severely restricting the ability to conduct work remotely.
Why apply to OHSU?:
We are Oregon's only public academic health center. In addition to caring for patients, we lead groundbreaking research. We also train the next generation of health care professionals. As Portland's largest employer, we give you opportunities to learn and advance in a system of hospitals and clinics across Oregon and Southwest Washington.
All are welcome. OHSU welcomes people of all ages, ethnicities, genders, national origins, religions and sexual orientations. We are striving to build an anti-racist, multicultural institution and encourage people with diverse backgrounds to apply. To request reasonable accommodation, contact askhr@ohsu.edu
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