JABSOM CLINICAL TRIALS COORDINATOR

Mar 22 2019
Job Description

JABSOM CLINICAL TRIALS COORDINATOR – ID# 19085. 

 

John A. Burns School of Medicine.  Regular, Full-Time, Limited Term (Not to exceed two (2) years in duration), RCUH Non-Civil Service position with the John A. Burns School of Medicine (JABSOM), 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:  Under the direction of the Associate Dean for Research and Graduate Education and the Associate Dean for Clinical Affairs, serves as the primary liaison with clinical investigators and ensures effective communication and support of the JABSOM clinical research enterprise.  Provides overall clinical management of the support program for clinical trials research across the John A. Burns School of Medicine in facilitating Federal, pharmaceutical company, and investigator-initiated clinical trials. Provides oversight and scheduling for the use of the clinical trials space.  Works with Principal Investigators to meet requirements for attaining program goals.  Oversees and liaises clinical trials support staff within JABSOM and University Health Partners (UHP) to enforce policies and distribute information, and to enable the successful conduct of clinical trials to meet all required deliverables.  Responsible for training and education of clinical research staff. Provides expertise in the overall project management for clinical trials to include assessment of new protocols and projects.  Coordinates with Principal Investigators, research administration, and compliance staff to help assure that operating procedures are in place.  Works with Principal Investigators to ensure adherence to all regulatory requirements.  Work force assignments and work processes may shift in response to current needs to support program goals.  Travels to meetings and conferences, as needed.  May require travel to off campus study sites. 

 

PRIMARY QUALIFICATIONS: EDUCATION/TRAINING:  Master’s Degree from an accredited college or university in a health related field.  EXPERIENCE:  At least five (5) years health-related research experience. Experience in project management and research.  ABIL/KNOW/SKILLS:  Advanced knowledge and understanding of clinical trial research, International Conference on Harmonization – Good Clinical Practice (ICH-GCP) guidelines, Food and Drug Administration (FDA) regulations, and clinical trials and study management practices.  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 clinical trials contract negotiations.  Proficient in developing reports for leadership oversight.  In-depth knowledge of industry trials with first-hand knowledge of all processes.  Knowledge of risk management.  Possesses accounting and computer skills particularly with Microsoft Word and Excel.  Ability to monitor expenditures and maintain data and confidentiality.  Ability to meet timelines that may require a flexible work schedule.  Possesses leadership skills, strong interpersonal skills (verbal and written) with a high degree of analytical ability, communication skills, conflict resolution skills, organization and planning skills, attention to detail, accuracy, desire to learn, and timeliness of work.  Ability to convey necessary information accurately, concisely to listen effectively, and to ask pertinent questions.  Ability to convey complex information in writing, telephone conversations, and direct interpersonal contacts.  Must possess a valid driver’s license (and if use of personal vehicle on the job is required, must also have valid personal driver’s insurance equivalent to Hawai‘i’s No-Fault Driver’s Insurance) and maintain throughout the duration of employment.  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 John A. Burns School of Medicine HIPAA/PHI privacy and security policy and the University Health Partner’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 John A. Burns School of Medicine  HIPAA/PHI privacy and security training and the University Health Partner’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.  

 

SECONDARY QUALIFICATIONS:  Medical Degree (MD) from an accredited college or university.  Knowledge of the RCUH and UH procedures and policies.  Experience in the use of databases to manage clinical research activities.  Seven to ten (7-10) years of related health research experience, including clinical trials experience. 

 

INQUIRIES:  Dr. Rachel Boulay 692-0986 (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:  April 11, 2019. 

 

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.