Junior Specialist Position

Department of Ophthalmology & Vision Science
UC Davis School of Medicine

The Department of Ophthalmology & Vision Science at the UC Davis School of Medicine is seeking a Junior Specialist in our Clinical Trials. The Junior Specialist will serve as the primary coordinator on the BRITE study, a funded, investigator-initiated trial looking at biomarkers associated with neovascular age-related macular degeneration. The Junior Specialist will provide support on multiple ophthalmology clinical studies including recruitment, data entry, lab processing and retention efforts. Additionally, this position assists the Research Supervisor with administrative and regulatory duties as needed.

This is an excellent opportunity for individuals interested in future careers in science, technology or medicine to gain experience in a stimulating and interactive laboratory environment.

Specific duties:
I. Research Coordination/Data Acquisition: 65%
The clinical trials unit within the Department of Ophthalmology conducts research projects spanning all subspecialties of Eye Care.

Contribute to basic science and clinical research projects by:

• Assist in all activities related to study start up (regulatory documents, IRB approval, Biosafety Committee application, training of other research personnel)
• Conduct informed consent process, following Standard Operating Procedures. Document informed consent appropriately.
• Perform research study procedures, including obtaining physical measurements (height and weight, ECG and blood pressure measurement).
• Assist MDs with investigational product (IP) administration.
  
• Interview participants regarding concomitant medications, adverse event reporting and medication compliance.
• Facilitate the ordering and pick up of investigational product maintained at the Investigational Drug Service (IDS). Ensure proper temperature tracking during transport.
• Administer study questionnaires (quality of life, etc.)
• Perform laboratory sample preparation for shipment to central laboratory as needed,: including proper handling (temperature and time) of collected blood and urine samples, centrifuge, aliquot and package per laboratory manual for each specific protocol.
• Following a completed study visit, perform case report form review to ensure source documentation meets the FDA ALCOA-C guidelines (attributable, legible, contemporaneous, original, accurate and complete).
• Perform data entry, utilizing sponsor identified electronic data capture (EDC) system.
• Register research subjects in CTMS OnCore and update study participation accordingly.
• Assist in preparing for monitoring teams and/or auditors assigned to each protocol, including gathering records, reports, scans and other necessary materials required for the monitor visit. For remote monitoring visits, prepare source documents and medical records for upload, redacting when appropriate. Complete discrepancy resolutions and data queries in a timely fashion.

II. Professional Competence and Activity : 25%

• Actively contribute to clinical trials unit activities through staff meetings.
• Mentor undergraduate student assistants from UC Davis.
  
• Run OnCore reports to ensure compliance with UC Davis Health research metrics

III. University and Public Service: 10%

• Attend annual Napa Valley Ophthalmology Symposium. Support outreach activities to increase awareness of ongoing clinical trials.
• Maintain log of Principal Investigator and research staff required training and certifications. Send reminders as needed to ensure 100% compliance.

Required Skills:

• Communication and interpersonal skills to effectively correspond with the public, coworkers, physicians, patients, caregivers, clinic staff, and other health care professionals.
• Knowledge and experience in clinical research
• Organizational skills and attention to detail required to maintain a large volume of records accurately.
• Ability to clearly and concisely document research data.
• Working knowledge of Microsoft Word, Excel, Outlook. Familiarity with Epic EMR and various industry Electronic Data Capture systems.
• Knowledge of basic anatomy and medical terminology, and ability to interpret physician notes, medical records, and laboratory results.

To apply, please visit: https://recruit.ucdavis.edu/JPF07377
Please direct questions to Ashley Bellmer at ambellmer@ucdavis.edu.

As a condition of employment, the finalist will be required to disclose if they are subject to any final administrative or judicial decisions within the last seven years determining that they committed any misconduct, are currently being investigated for misconduct, left a position during an investigation for alleged misconduct, or have filed an appeal with a previous employer.

• “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.
• UC Sexual Violence and Sexual Harassment Policy
• UC Anti-Discrimination Policy for Employees, Students and Third Parties
• APM - 035: Affirmative Action and Nondiscrimination in Employment

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