Clinical Research Coordinator II - Oncology

Clinical Research Coordinator II

Company: Lumi Research

Location: NW Houston (with travel to satellite sites) Company vehicle available for satellite travel.

Employment Type: Full-Time

Schedule: Monday – Friday, 8:00 AM – 5:00 PM

Salary Range: based on experience

Summary

At Lumi Research, we strive to provide urgent and comprehensive support to community-based oncologists as they deliver cutting-edge treatments to underserved patient populations.

The primary purpose of the Clinical Research Coordinator II (CRC II) is to facilitate patient enrollment and support the execution of clinical research activities, including regulatory record keeping, patient consenting and registration, and data and specimen collection for assigned clinical trials.

The CRC II will assist with or independently perform patient consenting, patient registration, data collection, and data entry while preparing regulatory documentation for monitoring visits as needed. This role plays a critical part in ensuring the successful onboarding and management of clinical trial participants for protocols conducted by Lumi Research and its clinician partners.

Employment Status

• Full-time 40 hours per week (not eligible for overtime)

Skills Required for Ideal Candidate

• Ability to apply prior knowledge and skills to complete clinical trial tasks effectively
• Strong critical thinking and problem-solving skills to resolve logistical challenges
• Excellent professional communication skills (verbal and written) when interacting with clinicians, sponsors, and patients
• Strong organizational skills with the ability to follow up on pending items
• Ability to multitask and prioritize responsibilities
• Proficiency with Microsoft Office tools and Microsoft Teams for communication and documentation

Preferred Skills (Not Required)

• Ability to perform phlebotomy on clinical trial patients according to protocol collection requirements
• Phlebotomy certification preferred

Roles and Responsibilities

Regulatory and Administrative Responsibilities

• Coordinate and attend study initiation visits and planning meetings as part of the research team
• Maintain current versions of study protocols and required documentation, including patient treatment consents
• Collect and document protocol source information including: Adverse events (serious and non-serious), completion of adverse event reporting, development of source documentation for assigned protocols with guidance from a Senior CRC
• Assist with annual protocol review processes, including toxicity report preparation when required
• Maintain delegation of authority logs and training logs
• Maintain screening and consent logs, including off-study dates and reasons for screen failures
• Maintain organized regulatory SharePoint folders across protocols
• Develop working knowledge of Electronic Data Capture (EDC) systems and patient registration systems

Study Coordination Responsibilities

• Coordinate, monitor, and follow all patient activities while enrolled in clinical trials
• Utilize screening checklists to support efficient patient onboarding
• Assist with maintaining institutional and facility contact lists to resolve logistical challenges
• Conduct the informed consent process under investigator supervision, including: treatment consents, tissue/specimen collection consents, and healthy participant consents
• Educate patients on trial requirements, procedures, and treatment schedules
• Maintain knowledge of protocol-specific procedures
• Coordinate research-related patient visits including: screening visits, tissue collection logistics, treatment visits (imaging, laboratory testing, physician exams, etc.)
• Create and maintain source documentation as required by protocol
• Ensure accurate and timely data entry in Electronic Data Capture (EDC) systems
• Respond to monitor queries related to data collection
• Track and document protocol deviations
• Administer patient questionnaires when required by protocol
• Maintain patient tracking tools including:
• Treatment cycles
• Lab and specimen collection
• Data collection and entry status
• Support Principal Investigator (PI) oversight by maintaining accurate patient tracking and providing status updates during sponsor or investigator meetings

Specimen Collection Responsibilities

• Coordinate and perform specimen collection according to protocol requirements, including:
• Blood
• Urine
• Saliva
• Buccal swabs
• Other specimens as required
• Package and ship specimens in accordance with protocol and laboratory guidelines

Required Education

Bachelor’s degree

Required Experience

Minimum three (3) years of experience in one or more of the following:

• Oncology clinical setting (clinic or research laboratory)
• Clinical trial research experience including:
• Data entry
• Patient consenting
• Regulatory coordination
• Bench research experience
• Clinical roles such as:
• Medical Assistant
• Laboratory Technician
• Similar patient-facing clinical roles

Equivalent experience may substitute for the required degree on a case-by-case basis.

Candidates must:

• Provide at least one professional reference from a current or former supervisor or colleague
• Be eligible to work in the United States
• Be willing to travel to satellite sites throughout Greater Houston area

Preferred Experience

• Prior experience serving as a Clinical Research Coordinator managing oncology trials (2 years preferred)

Benefits Overview

• Two weeks (80 hours) PTO annually, with accrual
• Monthly medical benefits stipend
• Clinical research certification support, including assistance maintaining continuing education hours