University of California - San Diego #97040 Clinical Trials Regulatory Research Associate in San Diego, California
#97040 Clinical Trials Regulatory Research Associate
Filing Deadline: Fri 12/21/2018
UCSD Layoff from Career Appointment: Apply by 12/11/18 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor.
Special Selection Applicants: Apply by 12/21/18. Eligible Special Selection clients should contact their Disability Counselor for assistance.
The Movement Disorder Center (MDC) was created to bring together faculty and staff who specialize in movement disorders, such as Parkinson's disease and related disorders, to work together as a multidisciplinary and comprehensive group to provide the best possible care for patients and advance clinical trial opportunities. Movement disorders are neurological conditions that affect the speed, control, quality and ease of movement.
The UC San Diego Movement Disorder Center is dedicated to providing the best diagnostic, therapeutic, palliative and supportive care to patients with movement disorders, in addition to state of the art research.The MDC is conducting clinical trials and is collaborating with investigators both within the UC System and outside the System. Our main objective is to improve the quality of life for our patients and their families and caregivers, while searching for significant ways to advance knowledge of these disorders through a multidisciplinary clinical and research team.
Under supervision, the Clinical Trials Regulatory Research Associate is responsible for the development and maintenance of regulatory documents pertaining to the clinical trials conducted by investigators at the University of California San Diego Parkinson's and Other Movement Disorders Center. The Regulatory Research Associate will act as a resource to investigators and staff for interpretation and execution of complex clinical research regulations, policies & procedures concerning the conduct of clinical phase I and II trials, including those of the FDA, HHS, the UCSD IRB/HRPP. The Clinical Trials Regulatory Research Associate will participate in data entry and data quality management activities that assess and continuously improve the quality of research activities.
This position requires effective communication with a variety of internal and external contacts including UCSD Parkinson's and Other Movement Disorders Center investigators and staff, UCSD IRB/HRPP staff, study sponsors and/or their representatives, FDA, etc. It will require to act as a liaison with UCSD departments, clinical research organizations (CRO), industry sponsors/contacts and community clinics/agencies.
This position will also include assisting in the planning, development and implementation of clinical research projects/studies related to Parkinson's disease, such as atypical Parkinson's disorders, progressive supranuclear palsy, corticobasal degeneration, multiple system atrophy, Lewy body disease, dementia and other related disorders, 2) provide coordination, testing, guidance and develop protocols in the execution of clinical research, and 3) monitor clinical trials, study related activities and provide recruitment support.
Theoretical knowledge of medical and pharmaceutical terminology and concepts, and/or biological science, as typically attained by a Bachelor's Degree in pharmacy, biology, hematology, or social sciences, sufficient to prepare, review and understand the contents of medical research protocols and amendments.
Working knowledge of FDA regulations, OPRP, HRPP policies and procedures, and HIPAA. Familiarity with the code of federal regulations (CFRs), Good Clinical Practice (GCP) guidelines and other regulations for the conduct of clinical research.
Experience working with clinical trials research activities, regulatory compliance, guidelines related to informed consent, ethical conduct, and protection of human subjects. Ability to interpret and comprehending complex clinical research protocols, activities and guidelines.
Demonstrated ability to read, understand, and learn study procedures from protocols. Strong problem-solving and decision-making skills.
Demonstrated ability to create or modify Informed Consent documents that comply with HRPP, FDA and other governing agencies.
Ability to abstract information from protocol and investigators brochures to create a stand-alone Research Plan requiring summarizing large quantities of data into concise and condensed applications of approximately 20 pages.
Experience researching information and ability to develop responsive, creative solutions to problems. Ability to analyze data to arrive at valid conclusions, recommendations and plans of actions. Detail oriented, logical and methodological approach to problem solving.
Expertise with personal computers and software programs (including Word, Excel, Power Point). Fast and accurate typing skills.
Familiarity with cooperative group agencies and trials including experience preparing and submitting a variety of forms related to research protocols in compliance with federal policies and other agencies with ability to pay conscientious attention to detail.
Excellent interpersonal, oral and written communication skills, including diplomacy, tact, and flexibility. Ability to interact with all organizational levels and to communicate effectively and professionally in person and via phone. Strong phone etiquette.
Ability to research, gather, evaluate, and organize information to produce clear and concise protocol reports using various resources and to perform tasks accurately and quickly, disseminate information effectively whether in report form or via presentation.
Strong ability to write policies, business correspondence, reports and procedure manuals, experience with editing and/or proofreading documents, excellent grammatical and proofreading skills. Ability to organize office and develop procedures; maintain and develop complex paper and electronic record management filing systems.
Familiarity with Institutional Review Board; experiences preparing and submitting continuing review materials, amendments, and other regulatory documents to an IRB.
Demonstrated experience handling human blood samples and working knowledge of protocols for shipping of biological substances.
Experience with multiple clinical research projects with complex logistics involving multi-sites and priorities. Ability to work with others in achieving organizational goals and deadlines.
Knowledge of neurological disease such as Parkinson's, dementia, Atypical Parkinson's Disorders such as Progressive Supranuclear Palsy, Corticobasal Degeneration, Multiple System Atrophy, Alzheimer’s Disease, Lewy Body Disease and other related disorders.
Excellent interpersonal skills including tact, diplomacy and flexibility. Ability to work independently and/or in a team framework in conjunction with principles of community and in a clinical research environment that interacts with a diverse group of researchers, technical personnel and others. Ability to maintain confidentiality as required.
Experience with regulations and legislation regarding the protection of human subjects. These include regulations under federal policies, FDA and other compliance agencies or directive.
Experience conducting neuropsychometric test batteries such as Digit Span Forward, Digit Span Backward, Verbal Fluency FAS, Wais-R Digit Symbol Substitution test, Category Fluency test, Trail Making Test and Clock Drawing Test, ADAS-Cog (Certification needed) and the Mini mental Status Exam (MMSEs).
Working knowledge of UCSD Human Research Protections Program (HRPP/IRB) policies and Procedures.
A Bachelor's Degree; or an equivalent of at least 2 years of research regulatory experience.
Employment is subject to a criminal background check and pre-employment physical.
Must be able to work occasional weekends as needed.
Must be IATA certified or able to obtain certification (International Air Transportation Association) to oversee shipping of biological substances.
Must be able to commute between Thornton/Perlman Hospitals, Hillcrest Medical Center, main UCSD campus, and La Jolla offices.
Must be willing to travel to national meetings.
UC San Diego Health is the only academic health system in the San Diego region, providing leading-edge care in patient care, biomedical research, education, and community service. Our facilities include two university hospitals, a National Cancer Institute-designated Comprehensive Cancer Center, Shiley Eye Institute, Sulpizio Cardiovascular Center, and several outpatient clinics. UC San Diego Medical Center in Hillcrest is a designated Level I Trauma Center and has the only Burn Center in the county. We invite you to join our dynamic team!
Applications/Resumes are accepted for current job openings only. For full consideration on any job, applications must be received prior to the initial closing date. If a job has an extended deadline, applications/resumes will be considered during the extension period; however, a job may be filled before the extended date is reached.
UC San Diego Health is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, age, protected veteran status, gender identity or sexual orientation. For the complete University of California nondiscrimination and affirmative action policy see: http://www-hr.ucsd.edu/saa/nondiscr.html
UC San Diego is a smoke and tobacco free environment. Please visit smokefree.ucsd.edu for more information.
SRA 2 NEX
Commensurate with Experience
Days, 8 hrs/day, Mon-Fri
As a federally-funded institution, UC San Diego Health maintains a marijuana and drug free campus. New employees are subject to drug screening.