Clinical Research Coordinator

About the Role

The Clinical Research Coordinator will manage and execute clinical and translational research studies for Principal Investigators within the Division of HIV, Infectious Diseases and Global Medicine at UCSF. This role involves significant patient interaction, specimen handling, data management, and study coordination across multiple research projects, including multicenter studies and international collaborations.

Key Responsibilities

• Screen, enroll, and conduct study visits with patients.
• Collect, process, store, and ship biological specimens:
• Respiratory specimens (bronchoscopy with bronchoalveolar lavage - BAL)
• Blood specimens (whole blood, serum, plasma, peripheral blood mononuclear cells - PBMCs)
• Other bodily fluids (semen, saliva)
• Prepare specimens using sterile laboratory techniques for molecular- and cell-based assays (e.g., 16S rRNA microarrays, Illumina DNA/RNA sequencing, telomere length and telomerase activity assays, PCR, ELISA, NGS).
• Inventory, store, and arrange proper transport (e.g., on dry ice) of specimens.
• Oversee incoming data interpretation from samples and ensure correct utilization for analysis and publications.
• Organize, manage, and update specimen transfer inventories; ensure specimen integrity and security.
• Perform pulmonary function testing, including spirometry, with appropriate laboratory training.
• Notify subjects and their primary care physicians of any concerns or abnormal results from pulmonary function testing.
• Oversee and receive shipments of biological specimens from international research sites.
• Purchase study-related supplies for both domestic and international sites.
• Clean, organize, and restock office and Biosafety Level II (BSL2) laboratory spaces.
• Act as an intermediary between ZSFG and UCSF clinical and research staff.
• Manage all aspects of research studies, including IRB and BUA applications and daily protocol conduct.
• Assist in the development, execution, modification, and revision of study protocols and laboratory procedures.
• Implement study protocols, coordinate studies, collect data/specimens, manage data, and perform quality assurance.
• Oversee processing and shipping of study samples; perform blood draws if a certified phlebotomist.
• Assist in the selection and hiring of new laboratory members.
• Train new laboratory members (fellows, residents, study coordinators, laboratory assistants, volunteers, students) in clinical and translational research.
• Execute tasks related to study screening, recruiting, enrolling subjects, collecting clinical data, and data entry.
• Collaborate with the statistician to create new systems for organizing clinical data and specimens.
• Audit research-related expenditures.
• Participate in conference calls and meetings, and lead lab meetings.
• Assist in preparing grant applications.
• Manage and assist in the initiation, implementation, and execution of future research studies.
• Assure compliance with relevant regulatory agencies.
• Oversee study data integrity.
• Implement and maintain periodic quality control procedures.
• Maintain regulatory documents.
• Report study progress to investigators.
• Participate in internal and external audits or reviews of study protocols.
• Perform other duties as assigned.

Requirements & Tech Stack

• High School Diploma or equivalent experience.
• Knowledge of Microsoft Word, Excel, Outlook, and other basic software programs.
• Sterile laboratory techniques.
• Biosafety Level II (BSL2) laboratory experience.
• Understanding of molecular- and cell-based laboratory assays.
• Experience handling infectious specimens (e.g., HIV+ and TB+).
• Experience with pulmonary function testing (spirometry).
• Experience with specimen processing and shipping (including dry ice).
• Experience with data management and organization.
• Experience with regulatory compliance.

Qualifications

• Current certification in Transportation of Dangerous Goods or ability to obtain within six months of hire.
• Required training (to be obtained and maintained upon hire):
• Laboratory Safety for Researchers
• Biosafety Training
• Blood-borne Pathogens Training
• Carcinogen Training
• Formaldehyde Training
• Hazardous Waste Management Training
• Safe Shipper Training
• Experience working with individuals in a clinical or clinical research setting (explaining medical tests, procedures, research risks/benefits).
• Knowledge of medical terminology, medical testing, and human subjects research.
• Attention to detail.
• Strong interpersonal skills.
• Excellent, effective verbal and written communication skills.
• Ability to multi-task in a fast-paced environment.
• Ability to work with a diverse subject population.
• Ability to work well independently.
• Ability to complete projects in a timely manner.
• Ability to prioritize multiple projects to ensure timely completion of essential tasks.
• Ability to obtain reproducible results.
• Excellent analytical and problem-solving skills.
• In-depth understanding of laboratory assays and ability to implement proper biosafety measures.

Preferred Qualifications

• Certified phlebotomy experience or equivalent certification to perform phlebotomy in California.
• Experience with processing specimens such as PBMCs or using advanced protocols for specimen processing.
• Experience with blood-borne pathogen specimen handling.
• Experience working with vulnerable patient populations in a medical setting.
• Experience with UCSF/ZSFG electronic medical records.
• Experience developing and maintaining clinical databases using REDCap and other software.
• Experience applying the following regulations and guidelines:
• Good Clinical Practice Guidelines
• Health Information and Accountability Act (HIPAA)
• The Protection of Human Research Subjects
• Regulations for recruitment and consent of research subjects
• Effective Cash Handling Procedures
• Environmental Health and Safety Training
• CDC’s Biosafety in Microbiological and Biomedical Laboratories
• Fire Safety Training