Clinical Research Coordinator

Overview

Coordinate oncology clinical trials, manage patient enrollment, data, and regulatory compliance.

Key Responsibilities

• data retrieval
• crf completion
• ae reporting
• regulatory submission
• ctms management
• specimen shipping

Tasks

-Ensure Roadmap accuracy for assessments, treatment arms, dosing modifications, and safety parameters. -Establish and follow daily routines for data retrieval, CRF completion, and query resolution. -Attend tumor boards, clinics, and multidisciplinary meetings to identify potential trial candidates. -Collaborate with physician investigators to identify, consent, screen, and enroll eligible patients into clinical trials. -Collect and submit clinical trial data to NCI, industry sponsors, and the institution with high accuracy and timeliness. -Submit Serious Adverse Events (SAEs), protocol deviations, and other reportable events to sponsors, IRB, and the institution per institutional and federal guidelines. -Participate in trial start-up activities including protocol review, Initial and Amended Roadmap submissions, and study-specific credentialing. -Report known protocol deviations within 7 business days; resolve outstanding items from monitoring visit letters within 4 weeks or before the next site visit. -Communicate barriers to activation and respond to administrative and regulatory staff regarding budget, billing, and compliance. -Communicate protocol-specific information to patients, physicians, and nurses; facilitate informed consent and coordinate initial work-up and treatment plans. -Prepare and submit initial and follow-up reports; ensure timely submission of regulatory documents to the CTO regulatory unit. -Ensure protocol compliance and coordinate follow-up procedures to assess treatment response and toxicity. -Complete case report forms (CRFs), including QOL surveys, radiologic scans, and staging tests, per protocol and sponsor requirements. -Maintain source documentation in patient charts; resolve queries and collaborate with data coordinators on patient visits and specimen handling. -Maintain and disseminate up-to-date protocol information and priority diagrams. -Maintain accurate patient status in CTMS and EPIC within 24 hours of enrollment or status change; link protocol-related visits in EPIC prior to scheduled appointments. -Actively participate in Disease Specific Focus Group Meetings; present research data and contribute to trial selection and feasibility discussions. -Prepare and ship protocol-related specimens in compliance with OSHA guidelines. -Screen newly diagnosed, progressed, or recurrent patients for trial eligibility, ensuring no ineligible patients are enrolled. -Lead and organize meetings, prepare agendas and minutes, and support program expansion and new project planning.

Requirements

• oncology
• study coordinator
• epic
• rave edc
• degree

What You Bring

-Oncology experience highly preferred. -2+ years of experience as a Study Coordinator required. -EPIC/Rave EDC experience highly preferred. -4-year degree required.

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Benefits

-Employee Assistance Program -Short and long-term disability -Time Off/Leave (PTO, Vacation or Sick Leave) -Medical, dental & vision -Life Insurance (Voluntary Life & AD&D for the employee and dependents) -Critical Illness, Accident, and Hospital -Health Spending Account (HSA) -Transportation benefits -401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available

About Actalent

-Born in July 2021 by merging Aerotek’s engineering & sciences arm with EASi, Actalent emerged as a focused engineering-and-science partner. -Backed by Allegis Group, it drives scale and speed to market via contract, managed, and technical services. -Headquartered in Maryland with global reach, it deploys specialized teams across North America, Europe, and APAC on Fortune 500 projects. -Typical engagements span EV design, vaccine development, lab services, clinical research, and infrastructure systems. -Expertise covers a wide spectrum: aerospace, defense, healthcare, manufacturing, software systems, environmental and civil engineering.

Sector Specialisms