CLINICAL RESEARCH REGULATORY ASSOC ID# 18216

May 25 2018
Category: Healthcare
Job Description

CLINICAL RESEARCH REGULATORY ASSOCIATE – ID# 18216

 

University of Hawai‘i Cancer Center.  Regular, Full-Time, RCUH Non-Civil Service position with the University of Hawai‘i Cancer Center, Clinical Trials Office (CTO), located in Honolulu, Hawai‘i. Continuation of employment is dependent upon program/operational needs, satisfactory work performance, availability of funds, and compliance with applicable Federal/State laws. 

 

MINIMUM MONTHLY SALARY:  $2,728/Mon. 

 

DUTIES:  Prepares initial clinical research study applications and patient consent forms for submission to the University of Hawai‘i Human Studies Program (UH HSP) and the Western Institutional Review Board (WIRB) for local site activation of national cooperative group, pharmaceutical-sponsored, and investigator-initiated clinical trials. Prepares annual continuation renewal applications, processes sponsor amendments, and responds to IRB stipulations and inquiries. Facilitates review of Serious Adverse Events (SAEs) with research staff and PIs and communicates relevant SAE reports to Institutional Review Boards (IRBs). Serves as liaison to all IRBs, Principal Investigator (PIs) and research staff, and IRB offices in other Center programs, and Hawai‘i Cancer Consortium institutions. Responsible for updating the database, website, and necessary spreadsheets with up-to-date regulatory information. Responsible for adhering to all Federal and local regulatory policies and procedures. 

 

PRIMARY QUALIFICATIONS: EDUCATION/TRAINING:  Bachelor’s Degree from an accredited four (4) year college or university in a health-related field.  EXPERIENCE:  One to three (1-3) years of experience working in a research field. Past experience to include demonstration of initiative and problem-solving skills.  ABIL/KNOW/SKILLS:  Knowledge of the practical and potential value of health care research. Working knowledge of medical terminology and able to interpret informed consent forms. Strong written and verbal communicationskills.  Mustbedetail oriented.Good analytical and organizationalskills.  Excellentword processing (MicrosoftWord), computing (Microsoft Excel),andpresentation (Microsoft PowerPoint) skills. GoodcommandofBusinessEnglishincludinggram​mar,spelling, arithmetic,andgeneralofficepracticesandpr​ocedures. Post Offer/Employment Condition:  Must be able to pass a post offer criminal background check. POLICY AND/OR REGULATORY REQUIREMENTS: As a condition of employment, employee will be subject to all applicable RCUH policies and procedures and, as applicable, subject to the University of Hawai‘i's Cancer Center’s HIPAA/PHI privacy and security policy. Violation of the RCUH's, the UH's, or the business entity's policies and/or procedures or applicable State or Federal laws and/or regulations may lead to disciplinary action (including, but not limited to possible termination of employment, personal fines, civil and/or criminal penalties, etc.). Must complete the University of Hawai‘i's Cancer Center’s HIPAA/PHI privacy and security training immediately after hire or not later than employee’s initial exposure to HIPAA/PHI. Must maintain a current status on the University’s and/or the business entity's training requirements. Must adhere to the University of Hawai‘i Cancer Center’s Bloodborne Pathogen Exposure Control Plan if applicable.  This includes requiring personnel who are at risk of infection, including employees, student and volunteers, to undergo (1) UH General Lab Safety Training and (2) Bloodborne Pathogen Standards training prior to the Hepatitis B pre-screening vaccination series and/or hepatitis B vaccination.  Personnel identified to be at risk are required to complete and sign the Hepatitis B Immunization form.  Completed forms must be submitted to the University of Hawai‘i Cancer Center Human Resources Office within ten (10) calendar days of initial assignment of duties.

 

SECONDARY QUALIFICATIONS:  Knowledge and/or experience with regulatory procedures, HIPAA compliance, and Federal and local regulations for research on human subjects. Familiar with clinical trials and informed consent process. General knowledgeof UH regulatory system, researchgrants,preparationofproposalsandr​eports. 

 

INQUIRIES:  Trina Adaro-Bell 564-5912 (Oahu). 

 

APPLICATION REQUIREMENTS: Please go to www.rcuh.com and click on “Job Postings.” You must submit the following documents online to be considered for the position: 1) Cover Letter, 2) Resume, 3) Salary History, 4) Supervisory References, 5) Copy of Degree(s)/Transcript(s)/Certificate(s). All online applications must be submitted/received by the closing date (11:59 P.M. Hawai‘i Standard Time/RCUH receipt time) as stated on the job posting. If you do not have access to our system and the closing date is imminent, you may send additional documents to rcuh_employment@rcuh.com. If you have questions on the application process and/or need assistance, please call (808)956-8344 or (808)956-0872. 

 

CLOSING DATE:  June 7, 2018. 

 

RCUH’s mission is to support and enhance research, development and training in Hawai‘i, with a focus on the University ofHawai‘i.

 

Equal Opportunities Employer – Minorities/Women/Disability/Veteran.