Clinical Research Coordinator II
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Actalent
Palo Alto, CA (In Person)
$100,528 Salary, Full-Time
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Job Description
Job Title:
Clinical Research Coordinator II Job Description This Clinical Research Coordinator II role focuses on independently conducting and coordinating complex interventional clinical trials, with a strong emphasis on oncology and early-phase treatment studies. You will manage key aspects of large research projects or all components of smaller studies, working closely with principal investigators and study teams to ensure high-quality patient care, accurate data collection, and strict regulatory compliance. The position is highly patient-facing and offers the opportunity to contribute to cutting-edge research at a leading academic institution while developing advanced skills in clinical trial coordination. Responsibilities Independently manage significant components of large clinical studies or all aspects of one or more smaller research studies. Oversee subject recruitment and enrollment to meet study goals, including developing and implementing effective strategies to promote participation and retain patients in long-term clinical trials. Coordinate and conduct patient visits throughout the trial, ensuring that each visit follows the study protocol and supports high-quality patient care. Serve as a primary patient-facing coordinator by organizing and managing the flow of each patient's study-related care, including scheduling, visit logistics, and communication with the care team. Perform chart reviews and pre-screen patients to assess eligibility for interventional treatment trials, particularly Phase I-II studies. Oversee data management for assigned research projects, including developing and managing systems to organize, collect, report, and monitor data. Extract, enter, analyze, and interpret clinical trial data, including working within electronic data capture (EDC) systems and electronic medical records. Develop project schedules, targets, and performance measurements, and track progress against study timelines and milestones. Lead team meetings related to assigned studies, prepare and approve meeting minutes, and ensure follow-up on action items. Formally supervise, train, and/or mentor new staff or students as assigned, including providing instruction on project work and contributing to performance feedback. Audit operations, including clinical and laboratory procedures, to ensure adherence to applicable regulations and study protocols, and lead efforts to identify and implement corrective actions and process improvements. Monitor Institutional Review Board (IRB) submissions and respond to requests and questions as needed to support ongoing regulatory compliance. Collaborate closely with principal investigators and study sponsors, including monitoring and reporting serious adverse events and resolving study-related queries. Provide leadership in recommending and implementing improvements to clinical research policies and processes, and help define best practices for study coordination. Assist in developing study budgets with the principal investigator and staff by distinguishing standard-of-care procedures from research-related activities. Track patient- and study-specific milestones and support invoicing to sponsors in accordance with study contracts. Ensure ongoing regulatory compliance by regularly reviewing study documents and confirming adherence to applicable guidelines and institutional policies. Work with principal investigators to support Investigational New Drug (IND) submissions to the FDA when applicable, and ensure that required IRB renewals are completed on time. Coordinate patient care during the trial by collaborating with physicians, nurses, and other clinical team members to ensure smooth execution of treatment protocols. Maintain accurate and timely documentation in EPIC and EDC systems related to patient visits, study procedures, and data collection. Essential Skills 2-5 years of experience as a Clinical Research Coordinator (CRC), with demonstrated ability to work independently on complex clinical trials. Hands-on experience coordinating interventional, sponsored clinical studies, rather than observational or survey-based research. Direct experience with treatment trials, specifically within Phase I-II clinical studies. Patient-facing clinical research experience, including direct coordination of patient visits and study-related care. Experience working as a coordinator at a clinical site (such as a hospital or academic medical center), rather than exclusively in pharmaceutical, contract research organization (CRO), or laboratory research settings. Proficiency with electronic medical record systems, including experience using EPIC for chart review and documentation. Experience with electronic data capture (EDC) systems for clinical trial data entry and management. Strong organizational skills with the ability to develop project schedules, track milestones, and manage multiple study activities simultaneously. Demonstrated ability to oversee data management processes, including data collection, monitoring, reporting, and basic analysis. Ability to lead or contribute to team meetings, document discussions, and follow up on action items. Strong communication skills to collaborate effectively with principal investigators, study sponsors, clinical staff, and patients. Knowledge of clinical research processes, including patient recruitment, informed consent, protocol adherence, and safety reporting. Understanding of regulatory and ethical requirements in clinical research, including familiarity with IRB processes and compliance expectations. Additional Skills & Qualifications Oncology clinical research experience, particularly within treatment trials, is highly preferred. Experience with complex clinical trials such as cardiology, CAR-T, or transplant studies is valuable, especially in early-phase settings. Phase I clinical trial experience is a significant plus, especially with multiple Phase I studies starting concurrently. Experience working with academic medical centers or large teaching hospitals. Prior involvement in developing or supporting study budgets and distinguishing standard-of-care from research procedures. Experience mentoring or training junior staff, students, or new team members in clinical research processes. Familiarity with monitoring and reporting serious adverse events and responding to sponsor or monitor queries. Ability to contribute to process improvement initiatives and help define best practices in clinical trial coordination. Comfort working in a highly collaborative environment with a hands-on principal investigator. Work Environment This role is fully onsite, with a standard schedule of Monday through Friday, approximately 8:00 a.m. to 5:00 p.m. The position is based in a clinical research setting within a leading academic institution, where you will work closely with physicians, nurses, and multidisciplinary research teams. The environment is highly patient-facing, and you will spend much of your time coordinating and supporting patient visits in an outpatient or hospital-based setting. After an initial training period, you may have the flexibility to perform some data-related tasks from home, while all patient-facing responsibilities remain onsite. You will work extensively with technologies such as the EPIC electronic medical record system and electronic data capture (EDC) platforms to manage clinical and research data. The role offers exposure to cutting-edge oncology and other complex treatment trials, particularly early-phase (Phase I-II) studies, in a structured, fast-paced academic research environment that emphasizes collaboration, mentorship, and professional development. Job Type & Location This is a Contract position based out of Palo Alto, CA. Pay and Benefits The pay range for this position is $41.00 - $51.00/hr. 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) Workplace Type This is a fully onsite position in Palo Alto,CA.
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