Clinical Research Coordinator II

BioTalent; Bellaire (TX); On-site; USD 55,000 - 85,000; Full time

Job summary

BioTalent in Bellaire, TX seeks an experienced Clinical Research Coordinator II to oversee day-to-day trial activities in a busy onsite site five days a week. You will coordinate start-up through close-out, manage regulatory documents, and work with investigators, sponsors, and staff to ensure protocol compliance and participant safety.

The ideal candidate has 2–4 years of clinical research experience or CRC certification, knowledge of FDA regulations, GCP, and ICH guidelines, and strong

Qualifications

• High school diploma or equivalent; college degree preferred.
• 2–4 years of clinical research experience or CRC certification.
• Experience coordinating clinical trials and working with research participants.
• Working knowledge of FDA regulations, GCP, and ICH guidelines.
• Familiarity with clinical research documentation, regulatory requirements, and study procedures.

Responsibilities

• Coordinate and manage assigned clinical trials from start-up through completion.
• Develop understanding of study protocols and requirements.
• Support start-up activities, including source documentation development and review.
• Screen potential participants, coordinate enrollment, and schedule visits.
• Review and obtain informed consent from participants.
• Perform protocol-specific procedures as delegated by the PI.
• Maintain regulatory and study documentation (IRB, source docs, logs).
• Complete CRFs accurately and timely.
• Coordinate with sponsors, labs, IRBs, and external partners.
• Report adverse events per protocol and regulatory requirements.

Skills

Clinical research experience

FDA regulations

GCP

ICH guidelines

Study coordination

Education

High school diploma or equivalent

Bachelor’s degree preferred

Tools

Microsoft Word

Microsoft Excel

Clinical trial systems

Job description

Position Overview

We are seeking an experienced Clinical Research Coordinator II (CRC II) to support the day-to-day execution and management of clinical trials. This individual will coordinate study activities, work closely with Principal Investigators, sponsors, study participants, and site leadership, and help ensure trials are conducted safely, efficiently, and in accordance with study protocols, FDA regulations, Good Clinical Practice (GCP), and applicable SOPs.

This is a full-time, onsite position requiring availability to work at the Bellaire, TX site five days per week.

Key Responsibilities

• Coordinate and manage assigned clinical trials from study start-up through completion.
• Develop a thorough understanding of study protocols, procedures, and requirements.
• Support study start-up activities, including development and review of source documentation.
• Screen potential participants, coordinate enrollment, and schedule study visits.
• Review and obtain informed consent from study participants.
• Perform protocol-specific study procedures as delegated by the Principal Investigator.
• Work with site leadership and recruitment teams to support study enrollment goals.
• Maintain accurate and complete regulatory and study documentation, including informed consents, source documents, IRB correspondence, subject logs, drug accountability records, and study communications.
• Complete CRFs accurately and within required timelines.
• Coordinate with sponsors, laboratories, IRBs, and other external partners.
• Track and report adverse events in accordance with study protocols and regulatory requirements.
• Support sponsor monitoring visits and respond to study-related questions or action items.
• Identify and communicate protocol deviations, study issues, and potential compliance concerns.
• Help ensure participant safety and the integrity and quality of clinical trial data.
• Participate in investigator meetings and contribute to SOP review and development as needed.

Qualifications

• High school diploma or equivalent required; college degree preferred.
• 2–4 years of clinical research experience or Clinical Research Coordinator certification.
• Experience coordinating clinical trials and working directly with research participants.
• Working knowledge of FDA regulations, GCP, and ICH guidelines.
• Familiarity with clinical research documentation, regulatory requirements, and study procedures.
• Strong understanding of medical terminology.
• Excellent written, verbal, and interpersonal communication skills.
• Strong organizational skills with the ability to manage multiple study priorities and deadlines.
• Ability to work independently while collaborating effectively with investigators, sponsors, site staff, and study participants.
• Comfortable using Microsoft Word, Excel, and clinical research systems/applications.
• Ability to work onsite in Bellaire, TX five days per week.