Clinical Research Coordinator II - The Nallamshetty Lab

PAVIR facilitates research and education activities conducted at the VA Palo Alto Health Care System. We work with more than 160 uniquely talented medical scientists and recruit employees who believe in making a difference in the lives of others through innovative health research.

About the role

The Clinical Research Coordinator II is responsible for coordinating and supporting the day-to-day operations of one or more clinical research studies. This position works closely with the Principal Investigator, study team, sponsors, regulatory bodies, and research participants to ensure studies are conducted in accordance with study protocols, Good Clinical Practice (GCP), institutional policies, and federal regulations.

Responsibilities

• Independently coordinate day-to-day operations of assigned clinical research studies.
• Oversee participant recruitment, screening, enrollment, and retention activities.
• Schedule and coordinate study visits, procedures, laboratory testing, and follow-up appointments.
• Educate participants regarding study procedures, risks, benefits, and expectations.
• Maintain ongoing communication with study participants throughout study participation.
• Coordinate participant retention activities.
• Independently conduct and coordinate complex study visits and research procedures in accordance with protocol requirements.
• Collect clinical information, questionnaires, medical histories, and research assessments.
• Collect, process, store, and ship specimens as applicable.
• Monitor participant safety and independently identify, escalate, and document adverse events and protocol deviations promptly.
• Coordinate with physicians, nurses, laboratories, pharmacies, imaging departments, and other clinical staff.
• Coordinate preparation and submission of study invoices and patient study payments.
• Maintain study supplies and monitor clinic/lab inventory.
• Maintain study regulatory binders and essential study documents.
• Prepare and submit regulatory documents to the IRB, Research & Development Committee, sponsors, and other oversight bodies.
• Ensure compliance with Good Clinical Practice (GCP), HIPAA, FDA regulations, VA requirements, and institutional policies.
• Maintain accurate source documentation and study records.
• Oversee data quality, perform data review, and independently resolve routine sponsor queries.
• Coordinate sponsor monitoring visits, audits, and site initiation activities.
• Communicate regularly with investigators, sponsors, monitors, and research collaborators.
• Assist with study start-up, implementation, and close-out activities.
• Monitor study performance, identify issues, and recommend solutions to investigators.
• Other tasks as assigned, such as manuscript preparation and scholarly activities.

Requirements

• Master's/Doctorate degree (or equivalent experience).
• Valid Driver License required.
• At least 2 years of experience supporting clinical research, healthcare, laboratory, or related scientific environments.

Qualifications

• Degree in a related field.
• Experience with grants and contracts function, clinical trial and research data management.
• Experience coordinating clinical research studies, recruiting research participants, collecting research data, and working with regulatory requirements.
• Knowledge of clinical research principles, Good Clinical Practice (GCP), human subjects protections, and research ethics gained through education or experience.
• Knowledge of applicable regulatory requirements, including HIPAA, FDA regulations, Institutional Review Board (IRB) requirements, and sponsor guidelines.
• Strong ability to read, interpret, and implement clinical research protocols and study procedures.
• Ability to coordinate multiple clinical research studies while managing competing priorities and meeting study deadlines.
• Strong organizational skills with exceptional attention to detail and documentation accuracy.
• Ability to collect, maintain, and manage accurate research data, source documentation, regulatory binders, and study records.
• Effective verbal and written communication skills with the ability to interact professionally with research participants, investigators, sponsors, monitors, and multidisciplinary clinical teams.
• Demonstrated ability to establish rapport with research participants while maintaining professionalism, confidentiality, and ethical research standards.
• Demonstrated ability to work independently and collaboratively in a fast-paced clinical research environment.
• Strong critical thinking, problem-solving, time management, and organizational skills.
• Proficiency with Microsoft Office Suite; experience with electronic medical records (EMR), REDCap, clinical trial management systems (CTMS), or other research databases is strongly desired.
• Knowledge of medical terminology is strongly desired.
• Previous experience coordinating clinical research studies, including participant recruitment, informed consent, study visits, regulatory submissions, and data management, is strongly desired.
• Knowledge of the VA healthcare system, VA clinical research policies and procedures, and experience working with industry-sponsored, federally funded, or investigator-initiated clinical trials is strongly desired.

Benefits

• Comprehensive health insurance, vision, and dental.
• 14 paid holidays.
• Paid vacation time and sick pay.
• 401(k) with a fully vested 6% company match and 3% profit share.
• Wellness program.
• Commuter benefits.
• Professional development training.
• Life, short-term disability, and long-term disability insurance (fully paid by PAVIR).

Schedule

This is a full-time position with 30–40 hours per week.