CTO ASSISTANT CLINICAL MANAGER – ID# 18530

Nov 06 2018
Category: Healthcare
Job Description

CTO ASSISTANT CLINICAL MANAGER – ID# 18530

 

University of Hawai‘i Cancer Center.  Regular, Full-Time, RCUH Non-Civil Service position with the University of Hawai‘i (UH) 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.

 

MONTHLY SALARY:  Salary commensurate with qualifications. 

 

DUTIES:  Supervises staff and activities supporting the UH Cancer Center Clinical Trials Office (CTO).  Under the direction of the CTO Clinical Manager and CTO Medical Director, provides day-to-day management of CTO clinical research professionals to meet work requirements.  Provides oversight to ensure appropriate research support is provided on a daily basis for investigators and Hawai‘i Cancer Consortium Institutions and community sites conducting cancer clinical trials (National Cancer Institute (NCI) sponsored, Pharmaceutical, and Investigator Initiated).  Ensures deliverables are met for any grant funding or contracts awarded to support the CTO roles and responsibilities.  Works with the Office of Research Services (ORS), UH Cancer Center Office of Compliance, Hawai‘i Cancer Consortium, and clinical trials management team to oversee the operation and successful completion of clinical trials; and to ensure that NCI, industry sponsored and investigator initiated protocols comply with UH Cancer Center and community hospital’s regulatory policies and procedures and that contract obligations including financial terms are adhered to. 

 

PRIMARY QUALIFICATIONS: EDUCATION/TRAINING:  Master’s Degree from an accredited college or university. (Bachelor’s Degree from an accredited four (4) year college or university and at least ten (10) years of health-related research experience may substitute for a Master’s Degree).  EXPERIENCE:  At least five (5) years of experience in research in a health related field, including at least four (4) years of oncology clinical research experience.  At least three (3) years of supervisory/management experience.  Experience working with pharmaceutical sponsors, Contract Research Organizations (CROs), and the NCI in face-to-face and teleconference meetings, monitoring visits, and external audits.  ABIL/KNOW/SKILLS:  Advanced knowledge and understanding of oncology research, International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) guidelines, Food and Drug Administration (FDA) regulations, and NCI oncology clinical trials and study management.   Knowledge of Federal and local regulations pertaining to human subjects’ research. Strong clinical trial management knowledge to include development of a budget, reconciliation of budget items and cancer clinical trials contract negotiations.  Proficient in developing reports for leadership oversight.  In-depth knowledge of NCI and industry trials with first-hand knowledge of all processes.  Knowledge of risk management  Strong interpersonal skills (verbal and written) with a high degree of analytical ability, communication skills, conflict-resolution skills, organizational and planning skills, accounting and computer skills particularly with Microsoft Word and Excel.  Ability to monitor expenditures, maintain data and confidentiality.  Ability to meet timelines that may require a flexible work schedule.  Post Offer/Employment Condition:  Must be able to pass a post offer criminal background check. Must complete the University of Hawai‘i's Cancer Center 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.  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 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 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 UH Cancer Center HR Office within ten (10) calendar days of initial assignment of duties.  

 

SECONDARY QUALIFICATIONS:  Knowledge of the UH Cancer Center, the Research Corporation of the University of Hawai‘i (RCUH) and UH procedures and policies.  Experience in the use of databases to manage clinical research activities. 

 

INQUIRIES:  Dr. Kate Bryant-Greenwood 441-7715 (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) Supervisory References, 4) 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:  November 26, 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.