Clinical Research Coordinator
About the role
This role supports complex oncology clinical trials from study start-up through close-out, serving as the primary contact for research participants, sponsors, and regulatory agencies. The Clinical Research Coordinator works directly with patients in a highly regarded academic environment, ensuring patient safety, protocol compliance, and accurate data collection while helping to advance cutting-edge oncology treatments.
Responsibilities
- Serve as the primary contact for research participants, sponsors, and regulatory agencies throughout the lifecycle of assigned clinical trials.
- Cook up clinical research studies from start-up through close-out, including planning, execution, and documentation of all study-related activities.
- Determine participant eligibility according to study protocols and obtain informed consent in compliance with regulatory and institutional requirements.
- Aid in developing and implementing effective patient recruitment and pre-screening strategies for treatment oncology trials.
- Cook up the collection, processing, and tracking of study specimens in accordance with protocol and laboratory requirements.
- Collect, review, and manage patient and laboratory data for clinical research projects, ensuring accuracy and completeness.
- Manage research project databases, including building and maintaining electronic data capture (EDC) systems, developing flow sheets, and preparing other study-related documents.
- Complete study documents and case report forms, ensuring that all entries accurately reflect source documentation.
- Ensure ongoing compliance with research protocols and regulatory requirements, reviewing and auditing case report forms for accuracy and consistency with source documents.
- Prepare regulatory submissions and ensure that Institutional Review Board (IRB) renewals and related documentation are completed accurately and on time.
- Assemble study kits for patient visits and ensure that all materials and documentation are prepared in advance of scheduled procedures.
- Monitor and coordinate the scheduling of study-related procedures and associated charges, ensuring appropriate documentation and alignment with protocol requirements.
- Cook up and organize study documents for monitoring visits, and attend sponsor monitoring meetings as the primary study contact.
- Maintain study expenditures and adherence to study budgets, collaborating with finance and management staff to resolve billing and financial issues.
- Interact regularly with the principal investigator to discuss study progress, ensure patient safety, and maintain proper study conduct.
- Ensure that essential documentation and patient research data are recorded and maintained in appropriate files in accordance with institutional and regulatory standards.
- Conduct monitoring visits and regulatory audits, providing required documentation and responding to findings as needed.
- Conduct chart reviews and perform patient pre-screening to identify eligible participants for oncology clinical trials.
- Work directly with patients in a hands-on capacity as part of the conduct of complex oncology clinical trials.
Essential Skills
- Minimum of 2 years of experience as a Clinical Research Coordinator (CRC).
- Demonstrated experience with complex clinical trials, preferably in oncology.
- Hands-on experience working directly with patients in a clinical research setting.
- Experience with treatment oncology trials, including patient-facing responsibilities.
- Proficiency in clinical research data collection and management, including use of electronic data capture (EDC) systems.
- Experience conducting chart reviews and pre-screening patients for clinical trial eligibility.
- Strong understanding of clinical research protocols and regulatory requirements, including IRB processes.
- Ability to coordinate studies from start-up through close-out, including regulatory submissions and study documentation.
- Strong attention to detail with the ability to review and audit case report forms for accuracy and completeness.
- Effective communication skills for interacting with patients, principal investigators, sponsors, and regulatory representatives.
Additional Skills & Qualifications
- Experience in bone marrow transplant (BMT) or cellular therapy clinical research is highly beneficial.
- Experience in academic or large institutional research environments.
- Familiarity with budgeting and financial tracking for clinical research studies.
- Experience developing flow sheets and other tools to support study workflow and data capture.
- Comfort working in a hybrid environment, balancing patient-facing responsibilities with remote data work.
- Strong organizational skills and the ability to manage multiple studies or tasks simultaneously.
- Motivation to contribute to cutting-edge oncology research within a renowned academic setting.
- Interest in a contract role with potential opportunity for direct hire based on performance.
Work Environment
The position is based in a prestigious academic research setting focused on oncology and complex clinical trials. The role follows a hybrid schedule, with approximately four days onsite each week and one potential flexible day working remotely after the initial training period. During onsite days, the coordinator works directly with patients and clinical teams in a patient-facing environment, supporting procedures, visits, and data collection. After the training period, some data-related tasks, such as electronic data capture, chart review, and documentation, may be completed from home. The work involves close collaboration with principal investigators, finance staff, and sponsors, as well as participation in monitoring visits and regulatory audits. The environment emphasizes rigorous adherence to institutional and regulatory standards, careful handling of study specimens and data, and a professional clinical setting appropriate for direct patient interaction.
Job Type & Location
This is a Contract position based out of Palo Alto, CA.
Pay And Benefits
The pay range for this position is $35.00 - $50.00/hr.
Requirements
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
- Medical, dental & vision
- Critical Illness, Accident, and Hospital
- 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
- Life Insurance (Voluntary Life & AD&D for the employee and dependents)
- Short and long-term disability
- Health Spending Account (HSA)
- Transportation benefits
- Employee Assistance Program
- Time Off/Leave (PTO, Vacation or Sick Leave)
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.