Stryker Corporation
TI Senior Clinical Research Assistant/TI Clinical Research Assistant 2
Stryker Corporation, Portland, Oregon, United States, 97204
TI Senior Clinical Research Assistant / TI Clinical Research Assistant 2
US-OR-Portland
Requisition ID:
2024-32552
Position Category:
Research
Job Type:
Research
Position Type:
Regular Part-Time
Posting Department:
Pulmonary, Allergy, and Critical Care Medicine
Posting Salary Range:
$50,128.00 - $75,171.20 for full-time, pro-rated based on FTE; commensurate with experience
Posting FTE:
0.60
Posting Schedule:
Tuesday, Wednesday, Thursday
Posting Hours:
9AM-5:30PM with the potential for occasional weekend coverage and the opportunity for longer shifts
HR Mission:
School of Medicine
Drug Testable:
Yes
Department Overview The Division of Pulmonary, Allergy, and Critical Care Medicine (PACCM) provides expert care for patients with lung diseases in our pulmonary clinics, allergic and immunologic disorders and diseases in our allergy clinics, and critically ill patients in our intensive care units. In addition to our commitment to outstanding clinical care, we are proud of our extensive research programs, from basic science to clinical trials. Our educational mission includes teaching on many levels, including our two fellowship programs in Pulmonary, Allergy, and Critical Care and Critical Care Medicine.
Function/Duties of Position Work schedule is Tuesday, Wednesday, Thursday from 9AM-5:30PM. Duties will be performed on-site in OHSU clinics, inpatient wards, emergency room or outside study centers or locations.
Clinical Trial Coordination Screen, recruit, and consent patients for clinical trials in either ambulatory or inpatient settings (including the intensive care unit and emergency department). Assist with study interventions and assessments, research subject visits, and data collection, including biologic samples. Collaborate with various OHSU departments to operationalize research protocol. Coordinate activities with clinical units, Research Pharmacy, OCTRI, and other areas as needed. Develop case report forms as needed. Perform electronic data entry and trial audits. Organize and maintain study records. Maintain study visit supplies. Attend research meetings as needed. Assist with site initiation and monitoring visits. Ensure compliance with all protocol and regulatory requirements, and help prepare required submissions and reports. Assist with tracking study related expenditures and preparing fiscal documentation for supervisor review/approval. Assist with training research staff in study protocols. Assist with data queries as needed. Accurately applies investigators' scientific data into a cohesive format for the protocol document and associated procedures that are consistent with internal and external policies and regulatory requirements.
Protocol Administration Assist with development of research protocols, IRB proposals, case report forms, and administrative requirements as necessary.
Student Worker and Volunteer Supervision Supervise student workers and volunteers, including recruitment, onboarding, scheduling, training and coaching volunteers and complying with division and institutional standards for managing volunteer programs. Supervise and audit work done by volunteers. Maintain volunteer records and conduct semi-annual evaluations for volunteers.
Contract Administration & Invoicing Responsible for clinical trial and/or industry study contract set up. Coordinate contract and invoicing processes as needed, assist with study set-up paperwork, and perform divisional review. Facilitate speedy processing of contracts and invoices. Assist with tracking study related expenditures and preparing fiscal documentation for supervisor review/approval.
IRB, IACUC and IBC Regulatory Liaison Assist and monitor PI and research staff compliance with institutional and state and federal regulations. Submit protocols, amendments, and continuing review documentation for IRB review. Ensure that studies are updated, and protocols kept compliant. Provide resources to PI and staff for all aspects of protocol creation and maintenance w/ IRB, IACUC and IBC. Ensure compliance with ClinicalTrials.gov reporting.
Other Responsibilities Other duties as assigned.
Required Qualifications
Bachelor's Degree (4 yr) in relevant field AND 1 year of relevant experience OR
Associate's AND 3 years of relevant experience OR
4 years of relevant experience OR
Equivalent combination of training and experience
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
Ability to navigate research site visits with industry sponsors, in-depth knowledge of budget development and clinical trial review
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
Preferred Qualifications
Working knowledge of FDA IDE/IND submission process, eCRIS, eIRB, and experience with REDCap.
Familiarity with electronic medical records (preferably EPIC), chart review and medical terminology.
BLS certification
Additional Details This position has the possibility of increasing to a 1.0 FTE.
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.
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US-OR-Portland
Requisition ID:
2024-32552
Position Category:
Research
Job Type:
Research
Position Type:
Regular Part-Time
Posting Department:
Pulmonary, Allergy, and Critical Care Medicine
Posting Salary Range:
$50,128.00 - $75,171.20 for full-time, pro-rated based on FTE; commensurate with experience
Posting FTE:
0.60
Posting Schedule:
Tuesday, Wednesday, Thursday
Posting Hours:
9AM-5:30PM with the potential for occasional weekend coverage and the opportunity for longer shifts
HR Mission:
School of Medicine
Drug Testable:
Yes
Department Overview The Division of Pulmonary, Allergy, and Critical Care Medicine (PACCM) provides expert care for patients with lung diseases in our pulmonary clinics, allergic and immunologic disorders and diseases in our allergy clinics, and critically ill patients in our intensive care units. In addition to our commitment to outstanding clinical care, we are proud of our extensive research programs, from basic science to clinical trials. Our educational mission includes teaching on many levels, including our two fellowship programs in Pulmonary, Allergy, and Critical Care and Critical Care Medicine.
Function/Duties of Position Work schedule is Tuesday, Wednesday, Thursday from 9AM-5:30PM. Duties will be performed on-site in OHSU clinics, inpatient wards, emergency room or outside study centers or locations.
Clinical Trial Coordination Screen, recruit, and consent patients for clinical trials in either ambulatory or inpatient settings (including the intensive care unit and emergency department). Assist with study interventions and assessments, research subject visits, and data collection, including biologic samples. Collaborate with various OHSU departments to operationalize research protocol. Coordinate activities with clinical units, Research Pharmacy, OCTRI, and other areas as needed. Develop case report forms as needed. Perform electronic data entry and trial audits. Organize and maintain study records. Maintain study visit supplies. Attend research meetings as needed. Assist with site initiation and monitoring visits. Ensure compliance with all protocol and regulatory requirements, and help prepare required submissions and reports. Assist with tracking study related expenditures and preparing fiscal documentation for supervisor review/approval. Assist with training research staff in study protocols. Assist with data queries as needed. Accurately applies investigators' scientific data into a cohesive format for the protocol document and associated procedures that are consistent with internal and external policies and regulatory requirements.
Protocol Administration Assist with development of research protocols, IRB proposals, case report forms, and administrative requirements as necessary.
Student Worker and Volunteer Supervision Supervise student workers and volunteers, including recruitment, onboarding, scheduling, training and coaching volunteers and complying with division and institutional standards for managing volunteer programs. Supervise and audit work done by volunteers. Maintain volunteer records and conduct semi-annual evaluations for volunteers.
Contract Administration & Invoicing Responsible for clinical trial and/or industry study contract set up. Coordinate contract and invoicing processes as needed, assist with study set-up paperwork, and perform divisional review. Facilitate speedy processing of contracts and invoices. Assist with tracking study related expenditures and preparing fiscal documentation for supervisor review/approval.
IRB, IACUC and IBC Regulatory Liaison Assist and monitor PI and research staff compliance with institutional and state and federal regulations. Submit protocols, amendments, and continuing review documentation for IRB review. Ensure that studies are updated, and protocols kept compliant. Provide resources to PI and staff for all aspects of protocol creation and maintenance w/ IRB, IACUC and IBC. Ensure compliance with ClinicalTrials.gov reporting.
Other Responsibilities Other duties as assigned.
Required Qualifications
Bachelor's Degree (4 yr) in relevant field AND 1 year of relevant experience OR
Associate's AND 3 years of relevant experience OR
4 years of relevant experience OR
Equivalent combination of training and experience
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
Ability to navigate research site visits with industry sponsors, in-depth knowledge of budget development and clinical trial review
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
Preferred Qualifications
Working knowledge of FDA IDE/IND submission process, eCRIS, eIRB, and experience with REDCap.
Familiarity with electronic medical records (preferably EPIC), chart review and medical terminology.
BLS certification
Additional Details This position has the possibility of increasing to a 1.0 FTE.
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.
#J-18808-Ljbffr