Research Coordinator - 134219

This position involves independent coordination, assistance with research trial management (including all operational components such as subject recruitment, eligibility screening, patient consenting and enrollment, scheduling visits and exams, conducting subject visits and assessments, managing electronic data and documents, and maintaining regulatory files). Coordinates and helps facilitate data entry by volunteer/other assistants, research analyses, in addition to preparation of abstracts and manuscripts.

• Independent research experience.

• Experience working with individuals affected by neurological diseases, especially Huntington's disease. Demonstrated performance in communicating effectively, and interacting sensitively and professionally with this population.

• Demonstrated ability to use findings to determine patient eligibility during recruitment and progress during study, identify potential abnormalities, and follow reporting procedures.

• Demonstrated experience working with medical charts and abstracting pertinent data from medical records throughout the community.

• Significant knowledge of FDA regulations, OPRP, HRPP, and HIPAA policies and procedures to interpret policy.

• Knowledge of the Code of Federal Regulations (CFR), Good Clinical Practice guidelines and other regulations for the conduct of clinical research.

• Good communication skills. Detail oriented.

• Experience working as a study coordinator in a clinical research environment that interacts with patients, families, physicians, and colleagues.

• Theoretical knowledge of medical and pharmaceutical terminology and concepts, and/or biological science that is generally acquired through a Bachelor's degree.

• Knowledge of clinical trial methodologies and general clinical research data collection methods.

• Ability to work in a laboratory environment which interacts with large number of research and technical personnel and other laboratories.

• Demonstrated knowledge and experience with laboratory procedures and reported values.

• Good organizational skills and ability to prioritize work.

• Demonstrated knowledge working with clinical trials research activities, regulatory compliance, guidelines related to informed consent, ethical conduct, and protection of human subjects as well as comprehending complex research protocols.

• Demonstrated ability to work independently, make appropriate determinations, and show resourcefulness.

• Demonstrated proficiency certification for commonly used assessment tools including but not limited to the MMSE, MoCA, SDM, HVLT-r, CDR-SB, FAS.

• Knowledge of investigational drug authorization criteria. Experience working with IVRS systems to log and dispense study medication.

• Knowledge of subject compliance/adherence issues and experience solving related problems.

• Demonstrated experience preparing research studies for IRB review including new project submissions, requested revisions, amendments and project renewals.

• Demonstrated ability to work independently, make appropriate determinations, and show resourcefulness.

• Demonstrated proficiency certification for commonly used assessment tools including but not limited to the MMSE, MoCA, SDM, HVLT-r, CDR-SB, FAS.

• Knowledge of investigational drug authorization criteria. Experience working with IVRS systems to log and dispense study medication.

• Demonstrated knowledge of standard software applications, including Word, Excel, PowerPoint, Outlook, and internet browsers. Proficient in utilizing such software programs to develop reports, presentations, and documents related to various projects and tasks. Demonstrated ability to learn new software programs.

• Demonstrated experience preparing research studies for IRB review including new project submissions, requested revisions, amendments and project renewals.

• Demonstrated ability preparing financial status reports related to study activities.

• Experience creating and producing materials such as newsletters; instructional, informative, and procedural documents; and web-based publications.

• Experience handling of biological fluids and universal biohazardous materials precautions. Working knowledge of shipping of biological materials, and EH&S policies and procedures for hazardous materials and laboratory safety.

• Excellent interpersonal skills including tact, diplomacy and flexibility with the ability to work in a team framework in conjunction with principles of community and to relate professionally and collaboratively with others. Ability to maintain confidentiality, and an appropriate clinical demeanor toward a wide variety of study participants and health care professionals.

• Demonstrated high level of initiative to prioritize work to meet deadlines, and to handle problems, propose solutions, and implement them.

• Excellent writing and verbal communications skills. Demonstrated ability to communicate effectively with a variety of people from different backgrounds.

• Demonstrated knowledge of standard software applications, including Word, Excel, PowerPoint, Outlook, and internet browsers. Proficient in utilizing such software programs to develop reports, presentations, and documents related to various projects and tasks. Demonstrated ability to learn new software programs.

• Experience with general lab maintenance.

• Experience with personal computers. Ability to use database and spreadsheet software.

• Knowledge of EH&S procedures for laboratory safety.

• Blood drawing - Certification in phlebotomy and experience working with patients. Demonstrated ability to perform phlebotomy.

• Employment is subject to a criminal background check.

If employed by the University of California, you will be required to comply with our Policy on Vaccination Programs, which may be amended or revised from time to time. Federal, state, or local public health directives may impose additional requirements.

If applicable, life-support certifications (BLS, NRP, ACLS, etc.) must include hands-on practice and in-person skills assessment; online-only certification is not acceptable.

UC San Diego Health Sciences is comprised of our School of Medicine, Skaggs School of Pharmacy and Pharmaceutical Sciences, The Herbert Wertheim School of Public Health and Human Longevity Science, and our Student Health and Well-Being Department. We have long been at the forefront of translational - or "bench-to-bedside" - research, transforming patient care through discovery and innovation leading to new drugs and technologies. Translational research is carried out every day in the hundreds of clinical trials of promising new therapies offered through UC San Diego Health, and in the drive of our researchers and clinician-scientists who are committed to having a significant impact on patient care. We invite you to join our 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.

To foster the best possible working and learning environment, UC San Diego strives to cultivate a rich and diverse environment, inclusive and supportive of all students, faculty, staff and visitors. For more information, please visit UC San Diego Principles of Community.

UC San Diego is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age or protected veteran status.

For the University of California's Affirmative Action Policy please visit: https://policy.ucop.edu/doc/4010393/PPSM-20
For the University of California's Anti-Discrimination Policy, please visit: https://policy.ucop.edu/doc/1001004/Anti-Discrimination

UC San Diego is a smoke and tobacco free environment. Please visit smokefree.ucsd.edu for more information.

UC San Diego Health maintains a marijuana and drug free environment. Employees may be subject to drug screening.

Misconduct Disclosure Requirement: As a condition of employment, the final candidate who accepts a conditional offer of employment will be required to disclose if they have been subject to any final administrative or judicial decisions within the last seven years determining that they committed any misconduct; received notice of any allegations or are currently the subject of any administrative or disciplinary proceedings involving misconduct; have left a position after receiving notice of allegations or while under investigation in an administrative or disciplinary proceeding involving misconduct; or have filed an appeal of a finding of misconduct with a previous employer.

a. "Misconduct" means any violation of the policies or laws governing conduct at the applicant's previous place of employment, including, but not limited to, violations of policies or laws prohibiting sexual harassment, sexual assault, or other forms of harassment, discrimination, dishonesty, or unethical conduct, as defined by the employer. For reference, below are UC's policies addressing some forms of misconduct:

• UC Sexual Violence and Sexual Harassment Policy
• UC Anti-Discrimination Policy
• Abusive Conduct in the Workplace