Job Description

CRA needed in Central US (Anywhere in the Central Time Zone)

Permanent position

Small Pharma Company

Job Title: Clinical Research Associate

Job Description

We are seeking a dedicated Clinical Research Associate (CRA) responsible for managing and monitoring clinical trial activities at assigned study sites, ensuring compliance with protocol, Good Clinical Practice (GCP), and applicable regulatory requirements. This role involves building collaborative relationships with investigative sites to ensure subject safety, protocol compliance, and the validity of study data.

Responsibilities

• Serve as the primary point of contact for investigators and site staff.

• Collaborate closely with sites to complete required site visits and perform site management activities to meet project timelines and deliverables.

• Ensure all site management and monitoring activities comply with ICH-GCP, SOPs, Clinical Monitoring Plan, Protocol, study plans, local laws, and regulations.

• Verify the accuracy and completeness of study data through source data review and verification.

• Conduct site staff training and retraining on study protocol requirements and procedures.

• Manage site-level queries, protocol deviations, and issues, escalating as necessary.

• Ensure timely and accurate updating of data systems by sites.

• Ensure timely and accurate reporting of adverse events, serious adverse events, and data safety.

• Prepare and submit visit reports, follow-up letters, and other documentation promptly.

• Maintain accurate and up-to-date study files, including regulatory documents and monitoring records.

• Support site audits and inspections.

• Support site feasibility assessments and patient recruitment strategies.

• Act as a liaison between sites and sponsors, ensuring effective communication and issue resolution.

• Work with sites to adapt, drive, and track the subject recruitment plan to enhance predictability.

• Attend project meetings and provide updates on site status and progress.

• Identify risks and recommend mitigation strategies.

• Ensure events are properly followed to completion.

• Lead and conduct presentations.

• Coordinate, organize, and manage clinical study coordinator teleconferences as needed.

Essential Skills

• Bachelor's Degree in a scientific discipline or healthcare preferred.

• Minimum 5 years of onsite monitoring experience.

• In-depth knowledge of, and skill in applying, applicable clinical research regulatory requirements, such as ICH-GCP guidelines.

• Ability to travel up to 80%, including overnight stays.

• Experience managing serious adverse events in collaboration with safety surveillance.

• Effective organizational, communication, and interpersonal skills.

• Ability to lead and conduct presentations.

• Experience in clinical trial management systems (CTMS), EDC platforms, and Microsoft Office suite.

• Strong analytical and problem-solving abilities.

• Experience working in a fast-paced, collaborative environment.

• Effective time and financial management skills.

Additional Skills & Qualifications

• Experience managing aspects of CRO functions is a plus.

• Prior experience in patient recruitment & retention strategies and site relationship management.

Work Environment

Join a goals-driven, passionate group where employees strive to meet objectives in a dynamic environment. As a smaller company, there is high visibility and a performance-driven culture. We offer a rewards program with compensation, cellphone reimbursement, tuition reimbursement, a 5% matching 401K, and great benefits, backed by the financial stability of the parent company.

Job Type & Location

This is a Permanent position based out of Houston, TX.

Pay and Benefits

The pay range for this position is $140000.00 - $160000.00/yr.

Other benefits are: Tuition reimbursement: 8K per year Holiday Pay 12 per year Vacation: at least 10 days annually Sick days 5 Annual performance bonus 10 - 15% Cell phone reimbursement $125 per month

Workplace Type

This is a fully remote position.

Application Deadline

This position is anticipated to close on Dec 19, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.

Job Tags

Similar Jobs