F

Flourish Research

Clinical trial optimization and operations efficiency

Clinical Research Coordinator - Oncology

Clinical Research OperationsConfirmed live in the last 24 hours
Full-timeWalnut Creek, CA, USA$37 - $48 /hr

About the Job

Requirements

  • A bachelor's degree in a life science, nursing, or related field is preferred; equivalent clinical research experience may be considered in lieu of a degree.
  • Two to three years of clinical research experience, including experience as a research assistant, or equivalent oncology clinical experience in nursing, an oncology clinic, or an infusion center.
  • Working knowledge of Good Clinical Practice, International Council for Harmonisation guidelines, and institutional review board requirements.
  • Ability to read and apply a protocol's clinical rationale, not just its procedural checklist.
  • Ability to manage multiple protocols and visit schedules concurrently.
  • Oral and written communication skills for interacting with participants under emotional or medical stress.
  • Proficiency with clinical trial management systems, electronic data capture systems, and Office 365.
  • Ability to drive and daily availability of an automobile.
  • Ability to lift 35 pounds and occasionally more than 35 pounds.

Responsibilities

  • Lead site-level start-up activities for assigned protocols, including regulatory binder build-out, informed consent form and source document development, supply ordering, and readiness for site initiation visits.
  • Read and maintain full command of each assigned protocol, including its mechanism of action, standard-of-care comparator, and rationale for eligibility and safety requirements.
  • Own recruitment strategy for assigned protocols through chart review, referral coordination with treating oncologists, and pre-screening against inclusion and exclusion criteria.
  • Conduct informed consent discussions, ensuring participants and families understand the diagnosis context, trial purpose, and how treatment history and disease state affect eligibility.
  • Independently perform and oversee protocol-specified clinical procedures, applying knowledge of the participant's disease state, prior treatment history, and clinical rationale behind each procedure.
  • Recognize when changes in a participant's clinical picture, including labs, symptoms, or treatment response, affect protocol eligibility or safety, and act on those changes.
  • Independently schedule, conduct, and manage the full cycle of patient visits according to protocol and sponsor timelines.
  • Coordinate investigational product accountability with the pharmacy team, including dispensing, counting, storage-condition monitoring, drug reconciliation at visits and study close-out, and destruction documentation, reconciling records against the accountability log.
  • Support the principal investigator or investigator in identifying, grading, and reporting adverse events and serious adverse events within protocol timelines and Flourish standard operating procedures, including distinguishing treatment-related events from disease progression.
  • Remove logistical barriers to care for assigned participants and families, including transportation, insurance, scheduling, and financial concerns.
  • Oversee laboratory processing for assigned protocols, including kit management, processing, storage conditions, shipping, and chain-of-custody documentation.
  • Maintain complete, contemporaneous, and accurate source documentation and study files, including filing, binder management, and logs.
  • Prepare for and host monitoring visits and resolve data queries directly with monitors, applying clinical judgment when required.
  • Enter and reconcile clinical trial management system billing and visit-based charges against study budgets, and flag discrepancies.
  • Support sponsor audits and regulatory inspections by retrieving requested source documents, answering procedural questions, and implementing assigned corrective actions.
  • Respond promptly and personally to participant and family calls, questions, and concerns.
  • Maintain communication with the principal investigator by raising clinical questions, safety signals, and protocol deviations that require physician-level judgment, and close the loop with participants.
  • Act as the primary site liaison for sponsor and contract research organization representatives, responding to queries, data clarification requests, and monitoring visit needs.
  • Communicate enrollment progress, study status, and site performance metrics to sponsors, and escalate protocol deviations or reportable events within required timelines.
  • Prepare for and support sponsor site visits, ensuring documentation readiness and timely resolution of monitoring findings.
  • Perform additional duties as assigned by management.
  • Travel to sponsor meetings, site initiation visits, and training.
  • Work in a clinical and typical interior or office environment with exposure to human bodily fluids and laboratory processing procedures, direct participant and patient care, and daily computer use.
  • Work occasional nights and weekends as needed to support study visits.

About the Company

Flourish Research

Clinical trial optimization and operations efficiency

Flourish Research helps healthcare and pharmaceutical clients run clinical trials more efficiently. It offers tailored optimization services that improve trial operations, aiming to reduce time and costs to bring new treatments to market. The company leverages decades of experience to provide quality-driven solutions, focusing on expanding capabilities, developing healthy teams, and implementing processes that enhance speed and quality across trial activities. Flourish Research differentiates itself by its client-specific approaches and strong emphasis on quality, team development, and operational excellence to deliver reliable trial outcomes.

Company size
501-1,000
Company stage
Not listed
Total funding
Not listed
Headquarters
Apex, NC
Founded
2021

Recently Posted Jobs

Explore more opportunities at Flourish Research

See more jobs