Staff Research Associate

The Research Associate will perform independently or with general direction at the fully operational journey level of the series to assist clinical research coordinators in their duties, as directed by the Clinical Research Supervisor and/or Principal Investigator (PI); may coordinate the data collection and operations of several concurrent clinical research studies under the guidelines of research protocols, UCSF and regulating agency policies.

Under the direct supervision of the Research Supervisor, incumbent's duties may include, but will not be limited to supporting coordinating the tasks of single or multiple clinical research studies, depending on their size and complexity; communicate between services and departments; logging and tracking of study specimens; track study results; and create, clean, update, and review databases and comprehensive datasets and reports; complete renewals and modifications of protocol applications and the implementation of new studies; participate in the review and writing of protocols to ensure institutional review board approval within University compliance; help assure compliance with all relevant regulatory agencies; monitor study data integrity; maintain periodic quality control procedures; interface with departments to obtain UCSF approval prior to study initiation; maintain regulatory documents; participate in any internal and external audits or reviews of study protocols; and perform other duties as assigned.

DUTIES & ESSENTIAL JOB FUNCTIONS

Identify the functions or tasks that employees in the job perform. The essential functions should state the purpose of the work and the results to be accomplished, rather than how the function is performed. Of the tasks listed, what percentage of time is devoted to each? The more time employees spend on a function, the more likely it is that the function is essential. Generally, include those functions that account for 10% or more of the work, i.e., key items that contribute significantly to the achievement of the job. The functions should add up to 100%.

20

Specimen Management/ Maintenance

• Under direct supervision by CRC or CRC Supervisor:
• Coordinate the exchange of and transport of specimens with collaborating Investigators and staff.
• QC the incoming data interpreted from samples and ensure that it is utilized correctly for analysis and publications.
• Ensure integrity and security of samples.

20

Enrolling Site Support

• Prepare laboratory kits for enrolling sites
• Monitor and address incoming site queries via email, phone, or videoconference
• Review and reconcile incoming invoices from sites

20

Data Management

• Collect, analyze and organize data
• Prepare figures for presentations and publication
• Participation in lab meetings

10

Study Recruitment

• Review patient electronic health records for eligibility in new trials
• Contact eligible patients to discuss studies
• Coordinate scheduling study visits with patients

10

Laboratory

• Monitor laboratory supply inventory
• Monitor and maintain specimen storage locations

10

Quality control procedures

• Confirm data integrity; review assessments of the adequacy of existing policies and procedures on subject recruitment, data collection, and data management.
• Update and maintain a procedure manual documenting all study-related procedures; help develop a plan to ensure consistency in data collection and data entry.
• Maintain periodic quality control procedures

10

100%

• HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities; and/or equivalent experience/training.
• Attention to detail; strong interpersonal skills; excellent, effective verbal and written communication skills to coordinate with subjects, team members, other departments and outside institutions; and the ability to multi-task in a fast-paced environment while working with a diverse subject population.
• Ability to work well independently, complete projects in a timely manner, and prioritize multiple projects to ensure the completion of essential tasks by deadlines.

Preffered Qualifications:

• Experience with electronic medical records.
• Knowledge of UCSF and departmental policies for dealing with reimbursement, guidelines for research, confidentiality and HIPPA regulations, following the UCSF mission statement and purpose for research, and a clear understanding of policies and procedures on patient safety and confidentiality (electronic and hard copy medical records, patient charts, communication, etc.); knowledge of medical terminology, research policies and guidelines, guidelines for packing/shipping infectious substances, database building/analysis, and data management within some of the following: Access, Stata, SASS/ SPSS, and Teleform programming platforms.
• Experience in analyzing datasets from clinical trials for secondary analyses and hypotheses generation
• Experience in clinical trials of cytomegalovirus in organ transplant recipients
• Creation of study reports, abstracts, and study manuscripts
• Experience applying the following regulations and guidelines:
  • Good Clinical Practice Guidelines
  • Health Information and Accountability Act (HIPAA)
  • The Protection of Human Research Subjects
  • IRB regulations for recruitment of research subjects

• HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities; and/or equivalent experience/training.
• Attention to detail; strong interpersonal skills; excellent, effective verbal and written communication skills to coordinate with subjects, team members, other departments and outside institutions; and the ability to multi-task in a fast-paced environment while working with a diverse subject population.
• Ability to work well independently, complete projects in a timely manner, and prioritize multiple projects to ensure the completion of essential tasks by deadlines.

Preffered Qualifications:

• Experience with electronic medical records.
• Knowledge of UCSF and departmental policies for dealing with reimbursement, guidelines for research, confidentiality and HIPPA regulations, following the UCSF mission statement and purpose for research, and a clear understanding of policies and procedures on patient safety and confidentiality (electronic and hard copy medical records, patient charts, communication, etc.); knowledge of medical terminology, research policies and guidelines, guidelines for packing/shipping infectious substances, database building/analysis, and data management within some of the following: Access, Stata, SASS/ SPSS, and Teleform programming platforms.
• Experience in analyzing datasets from clinical trials for secondary analyses and hypotheses generation
• Experience in clinical trials of cytomegalovirus in organ transplant recipients
• Creation of study reports, abstracts, and study manuscripts
• Experience applying the following regulations and guidelines:
  • Good Clinical Practice Guidelines
  • Health Information and Accountability Act (HIPAA)
  • The Protection of Human Research Subjects
  • IRB regulations for recruitment of research subjects