Clinical Research Coordinator III

Helios Clinical Research; Keller (TX); On-site; USD 60,000 - 75,000; Full time

Benefits offered by this job

Stipend payments

Job summary

Helios Clinical Research is seeking a Clinical Research Coordinator III to support the management and oversight of clinical trials. You will work with a team under the Site Operations Manager, ensuring trials run smoothly and data is collected accurately.

The role involves coordinating participant visits, monitoring safety, and maintaining regulatory compliance across multiple sites, with Keller as the home base and travel to nearby sites as needed.

Qualifications

• 3 years' experience in Clinical Research preferred.
• Bachelor's degree preferred in a health-related field.

Responsibilities

• Oversee 5+ trials and ensure trouble-free running of clinical trials.
• Collect data obtained from research and manage study data.
• Communicate with study participants regarding study objectives and monitor adherence to study rules.
• Liaise with laboratories and ensure regulatory compliance.
• Maintain research records including case report forms and drug dispensation records.
• Direct specimen collection, labeling, storage, and transport.
• Ensure all necessary equipment and supplies are in stock and functional.

Education

Bachelor's degree in health-related field

Tools

EDC

Job description

• Location 330 N Rufe Snow Drive,Keller, TX, 76248,United States
• Employee Type Non-Exempt - FT

Job Title

Clinical Research Coordinator III

FLSA Classification

Non-Exempt

Reports to

Site Operations Manager

This position will float between Keller, Dallas, and Flower Mound, with Keller as the home base

Job Summary/ Objective

The Clinical Research Coordinator III is responsible for supporting the management and oversight of clinical trials. This role involves working closely with a team to ensure the smooth execution of research studies under the guidance of the Site Operations Manager.

Essential Functions

Overseeing Clinical Trials

• Ensure trouble-free running of clinical trials.
• Monitor study participants’ health throughout the trial.
• Compile reports summarizing the success or failure of drugs, technologies, or medical procedures.
• Oversee 5+ trials

Data Collection and Analysis

• Collect data obtained from research.

Participant Interaction

• Communicate with study participants regarding study objectives.
• Monitor participant adherence to study rules.

Collaboration and Compliance

• Liaise with laboratories
• Monitor study compliance with protocols and ethical standards.
• Ensure adherence to regulatory requirements.

Record Keeping

• Maintain research records, including case report forms and drug dispensation records.
• Direct specimen collection, labeling, storage, and transport.

Logistics and Supplies

• Ensure all necessary equipment and supplies are in stock and functional.

Education/Experience/Skills

Education

Bachelor's degree preferred in a health-related field

Experience

3 years' experience in Clinical Research preferred

Skills

Regulatory

• Filing and accessing documents, Study Submission Assistant, Conduct close-out visits

Finance

• Stipend payments

Subject Interaction

• Recruit, interview, screen, enroll, and randomize subjects
• Collect medical history
• Conduct study visits

Administrative

• EDC
• Query resolution
• AE/SAE documentation and reporting
• Address protocol violations and deviations
• Order supplies

Clinical Skills

• Vital Signs
• ECG

Study Management

• Conduct PSSV’s and SIV’s
• Complete Feasibility Questionnaires
• Manage trials from start to closeout

Working Conditions/ Physical Demands

Standard operating hours are Monday through Friday, 8:00 a.m. to 5:00 p.m. May be required to complete job-related tasks outside of that time frame in excess of a standard 40-hour work week. Requires prolonged walking, standing, some bending, stooping, and stretching. Requires hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Requires normal range of hearing and eyesight to record, prepare, and communicate appropriate reports.

Travel required: as needed (travel to IM’s may be required)

Disclaimer

This job description may not be inclusive of all assigned duties, responsibilities, or aspects of the job described, and may be amended at any time at the sole discretion of the Employer.