Clinical Trials Specialist

Job Description

Location: Houston, TX

We are seeking a detail-oriented and experienced Clinical Trials Specialist to support the successful execution of clinical trials. This role involves coordinating trial activities, ensuring compliance with regulatory guidelines, and serving as a liaison between study teams, investigators, and sponsors. The ideal candidate will have a solid background in clinical research, exceptional organizational skills, and a commitment to upholding the highest standards in clinical trial management.

Responsibilities:

• Assist in the planning, execution, and monitoring of clinical trials to ensure adherence to protocols, timelines, and budgets.
• Coordinate with investigators, site staff, and study teams to ensure smooth trial operations.
• Prepare and maintain trial documentation, including informed consent forms, study protocols, and regulatory submissions.
• Ensure compliance with Good Clinical Practice (GCP), regulatory requirements, and sponsor guidelines.
• Monitor trial sites to ensure proper data collection, documentation, and adherence to the study protocol.
• Address and resolve trial-related queries, issues, and deviations in collaboration with site staff and sponsors.
• Facilitate communication among study team members, clinical sites, and external stakeholders.
• Track and manage trial supplies, budgets, and schedules.
• Support the preparation of interim and final study reports, as well as regulatory submissions.
• Stay informed of regulatory updates and changes impacting clinical trials.

Qualifications:

• Bachelor’s degree in life sciences, healthcare, or a related field.
• Minimum of 2-3 years of experience in clinical trial coordination or management.
• Thorough understanding of Good Clinical Practice (GCP) and clinical research regulations (FDA, ICH).
• Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) tools.
• Strong organizational and time management skills, with exceptional attention to detail.
• Excellent interpersonal and communication skills, with the ability to work effectively in a team.
• Problem-solving mindset with a proactive approach to addressing challenges.
• Certification in clinical research (e.g., CCRA, CCRP, or equivalent) is a plus.

Salary Range: The salary range for this position is $60,000 –  $80,000 a year based on experience. 

Interview Process:

• Initial Screening Call with TalentLNX.
• Zoom Interview with Clinical Operations Leadership.
• Final Interview with Sponsors/Key Stakeholders.

Equal Opportunity Employer: TalentLNX is committed to equal employment opportunity and prohibits discrimination and harassment of any kind. We are dedicated to building a diverse workforce and fostering an inclusive work environment where all employees and candidates are treated with respect and dignity. We do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, genetic information, disability, or any other protected status under applicable law. We actively seek to recruit, develop, and retain talented individuals from diverse backgrounds, and we encourage all qualified candidates to apply for our job opportunities.