CRA II- Immunology (Dallas, TX)

Syneos Health; Town of Texas (WI); On-site; USD 62,000 - 146,000; Full time

Job summary

An established industry player is seeking a Clinical Research Associate II to join a dynamic team focused on accelerating therapy delivery. This role involves performing site management activities, ensuring compliance with regulations, and collaborating with passionate problem solvers. The ideal candidate will possess a strong background in clinical research, excellent communication skills, and the ability to adapt to new technologies. Join a company that values diversity and fosters a culture of growth and support, making a real impact on patient lives while enjoying a comprehensive benefits package.

Benefits

Company Car or Allowance

Health Benefits

401k Match

Stock Purchase Plan

Bonuses

Flexible PTO

Qualifications

• Bachelor’s degree or RN in a related field or equivalent experience.
• Knowledge of GCP/ICH and regulatory requirements.

Responsibilities

• Perform site qualification, initiation, monitoring, and close-out visits.
• Document activities, support recruitment and retention strategies.

Skills

GCP/ICH Knowledge

Communication Skills

Interpersonal Skills

Computer Skills

Adaptability to New Technologies

Education

Bachelor’s Degree or RN

Equivalent Experience

Job description

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Clinical Research Associate II

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities.

Our Clinical Development model centers on the customer and the patient. We strive to simplify and streamline our work, making Syneos Health a better partner and employer.

Whether in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers to help our customers achieve their goals. We are agile and driven to accelerate therapy delivery because we are passionate about changing lives.

Discover what our 29,000 employees across 110 countries already know:

WORK HERE MATTERS EVERYWHERE

Why Syneos Health

• We are passionate about developing our people through career growth, support, training, recognition, and rewards.
• We foster a Total Self culture—where you can be authentic. We are dedicated to caring for our people.
• We value diversity of thought, backgrounds, and perspectives, creating a sense of belonging for all.

Job Responsibilities

• Perform site qualification, initiation, monitoring, management activities, and close-out visits (on-site or remote), ensuring compliance with regulations, ICH-GCP, and protocol. Use judgment to evaluate site performance and escalate issues as needed.
• Verify informed consent process, protect confidentiality, and assess safety and data integrity factors.
• Follow the Clinical Monitoring/Site Management Plan, including assessing site processes, reviewing source documents, verifying data, and applying query resolution techniques.
• Support investigational product inventory, reconciliation, and storage reviews. Ensure proper dispensing and adherence to protocols.
• Review the Investigator Site File for accuracy and completeness, and reconcile with the Trial Master File.
• Document activities, support recruitment and retention strategies, and track observations and actions.
• Manage project scope, budget, and timelines at the site level, adapting to changing priorities.
• Act as liaison with study site personnel, ensuring training and compliance.
• Prepare for and attend meetings, contribute to audit readiness, and support audit processes.
• Maintain knowledge of guidelines, regulations, and SOPs; complete required training.
• For Real World Late Phase, support site management from identification to close-out, including data collection and collaboration with stakeholders.

Qualifications

• Bachelor’s degree or RN in a related field, or equivalent experience.
• Knowledge of GCP/ICH and regulatory requirements.
• Strong computer skills and adaptability to new technologies.
• Excellent communication and interpersonal skills.
• Ability to travel up to 75% regularly.

Get to know Syneos Health

We have worked with 94% of all FDA-approved drugs and 95% of EMA-authorized products, across numerous studies and sites.

Join us to challenge the status quo in a dynamic environment. Learn more about Syneos Health.

Additional Information

Tasks and responsibilities may be adjusted at the company's discretion. Qualifications may be considered equivalent. This description does not constitute a contract. We comply with all applicable laws, including the ADA, and offer benefits such as a company car or allowance, health benefits, 401k match, stock purchase plan, bonuses, and flexible PTO.

The salary range for this position is $62,000 to $145,100, depending on qualifications and experience.

Syneos Health encourages vaccination and may require proof of COVID-19 vaccination where applicable.

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Research and Science

Industries

• Biotechnology Research, Pharmaceutical Manufacturing, Research Services