CRRC Administrator Protocol Support Specialist - (Research Associate/Sr. Clinical Research Assistant
Company Name:
Oregon Health & Science University
Job Title
CRRC Administrator Protocol Support Specialist - (Research Associate/Sr. Clinical Research Assistant)
Department
Knight Cancer Institute - Knight Clinical Trials Office (KCTO)
Location
HRC 14D40
Work Unit Description
The mission of the Knight Clinical Trials Office (KCTO) is to foster a supportive environment conducive to achieving the Knight's clinical research mission. The KCTO provides a central location for policies, procedures, and systems to aid investigators and research groups with respect to trial development, execution, and oversight.
Work Schedule, Hours, FTE, Salary Range
Monday - Friday, Occasional Nights and Weekends; 1.0 FTE; Salary Range: $50,000-$65,000 DOE; Location: Center for Health and Healing (CHH), South Waterfront
Functions/Duties of Position
The CRRC Administrator/Protocol Support Specialist evaluates clinical trial submissions to ensure compliance with Knight centralized policies and procedures as well as working directly with KCTO administrative staff to ensure accurate recording of trial information in the electronic clinical trial management system i.e. eCRIS (formerly Surveyor) . Utilizing clearly defined expectations and effective communication skills, this position works directly with investigators to strengthen the quality of their submissions and clarify discrepancies prior to committee review. This position also works directly with Knight Leadership, the Chair and Co-Chair of the Clinical Research Review Committee (CRRC) and the CRRC Membership to facilitate the review of oncology trials as outlined in Knight Policy and the Knight Data and Safety Monitoring Plan.
Job Requirements
Required:
Master's degree with major courses in relevant field and 3 years of relevant experience OR Bachelor's degree, with major courses in field of research (or RN or allied health professional) plus current ACRP or SoCRA certification and 3 years of relevant experience OR Bachelor's degree with major courses in field of research (or RN or allied health professional) and 7 years of relevant experience preferably in sciences or healthcare. Strong clinical research knowledge with a minimum of 2 years of clinical research coordination or similar role
Working knowledge of FDA and other regulatory guidelines (i.e. HIPAA) that govern clinical research
Ability to translate knowledge into policies and practices; experience in regulatory management of clinical research (planning, amendments, annual reviews, etc)
Working knowledge of Word, Excel, and other Microsoft Office programs
Demonstrated ability to work with a variety of diverse doctors, nurses and outside entities
Excellent record of time management and setting appropriate priorities
Excellent communication skills; ability to express and document ideas clearly and concisely in written communications; able to champion personal convictions while maintaining the ability to listen, comprehend, and adjust, when required, to other points of view
Self-starter with ability to work independently but collaboratively; demonstrated ability to work independently and as part of a team; capable of establishing and maintaining effective working relationships with a range of individuals from a variety of departments, institutions and organizations; ability to lead a group, serve as a mentor and/or facilitator, and create a positive work environment
Strong critical thinking skills
Strong problem-solving abilities and multi-tasking capabilities
Detail oriented while still seeing the big picture
Solution-oriented approach to issues
Demonstrated ability to ensure and deliver a customer service orientation that translates into timely and reliable guidance / service to PIs and staff
Demonstrated ability to manage QA plan and execute projects, organize and track data/metrics, collaborate with domain leadership and OHSU leadership
Preferred:
Master's degree, with major courses in relevant field
Experience coordinating investigator-initiated clinical research studies
Demonstrated experience with the items on left.
ACRP or SoCRA Certifications e.g. CCRC, CCRA, CCRP, etc.
Additional Details
OHSU is an equal opportunity, affirmative action institution. All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of disability or protected veteran status. Applicants with disabilities can request reasonable accommodation by contacting the Affirmative Action and Equal Opportunity Department at .
How To Apply
Apply here online. Please attach CV/Resume, cover letter and list of 3 references.
Referral Bonus Eligible
Referral Bonus Amount
Drug Testable
NoEstimated Salary: $20 to $28 per hour based on qualifications.
Oregon Health & Science University
Job Title
CRRC Administrator Protocol Support Specialist - (Research Associate/Sr. Clinical Research Assistant)
Department
Knight Cancer Institute - Knight Clinical Trials Office (KCTO)
Location
HRC 14D40
Work Unit Description
The mission of the Knight Clinical Trials Office (KCTO) is to foster a supportive environment conducive to achieving the Knight's clinical research mission. The KCTO provides a central location for policies, procedures, and systems to aid investigators and research groups with respect to trial development, execution, and oversight.
Work Schedule, Hours, FTE, Salary Range
Monday - Friday, Occasional Nights and Weekends; 1.0 FTE; Salary Range: $50,000-$65,000 DOE; Location: Center for Health and Healing (CHH), South Waterfront
Functions/Duties of Position
The CRRC Administrator/Protocol Support Specialist evaluates clinical trial submissions to ensure compliance with Knight centralized policies and procedures as well as working directly with KCTO administrative staff to ensure accurate recording of trial information in the electronic clinical trial management system i.e. eCRIS (formerly Surveyor) . Utilizing clearly defined expectations and effective communication skills, this position works directly with investigators to strengthen the quality of their submissions and clarify discrepancies prior to committee review. This position also works directly with Knight Leadership, the Chair and Co-Chair of the Clinical Research Review Committee (CRRC) and the CRRC Membership to facilitate the review of oncology trials as outlined in Knight Policy and the Knight Data and Safety Monitoring Plan.
Job Requirements
Required:
Master's degree with major courses in relevant field and 3 years of relevant experience OR Bachelor's degree, with major courses in field of research (or RN or allied health professional) plus current ACRP or SoCRA certification and 3 years of relevant experience OR Bachelor's degree with major courses in field of research (or RN or allied health professional) and 7 years of relevant experience preferably in sciences or healthcare. Strong clinical research knowledge with a minimum of 2 years of clinical research coordination or similar role
Working knowledge of FDA and other regulatory guidelines (i.e. HIPAA) that govern clinical research
Ability to translate knowledge into policies and practices; experience in regulatory management of clinical research (planning, amendments, annual reviews, etc)
Working knowledge of Word, Excel, and other Microsoft Office programs
Demonstrated ability to work with a variety of diverse doctors, nurses and outside entities
Excellent record of time management and setting appropriate priorities
Excellent communication skills; ability to express and document ideas clearly and concisely in written communications; able to champion personal convictions while maintaining the ability to listen, comprehend, and adjust, when required, to other points of view
Self-starter with ability to work independently but collaboratively; demonstrated ability to work independently and as part of a team; capable of establishing and maintaining effective working relationships with a range of individuals from a variety of departments, institutions and organizations; ability to lead a group, serve as a mentor and/or facilitator, and create a positive work environment
Strong critical thinking skills
Strong problem-solving abilities and multi-tasking capabilities
Detail oriented while still seeing the big picture
Solution-oriented approach to issues
Demonstrated ability to ensure and deliver a customer service orientation that translates into timely and reliable guidance / service to PIs and staff
Demonstrated ability to manage QA plan and execute projects, organize and track data/metrics, collaborate with domain leadership and OHSU leadership
Preferred:
Master's degree, with major courses in relevant field
Experience coordinating investigator-initiated clinical research studies
Demonstrated experience with the items on left.
ACRP or SoCRA Certifications e.g. CCRC, CCRA, CCRP, etc.
Additional Details
OHSU is an equal opportunity, affirmative action institution. All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of disability or protected veteran status. Applicants with disabilities can request reasonable accommodation by contacting the Affirmative Action and Equal Opportunity Department at .
How To Apply
Apply here online. Please attach CV/Resume, cover letter and list of 3 references.
Referral Bonus Eligible
Referral Bonus Amount
Drug Testable
NoEstimated Salary: $20 to $28 per hour based on qualifications.
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