Experienced Clinical Research Associate

Experienced Clinical Research Associate – Full‐Service – Oncology

Updated: Yesterday

Location: USA-AL-Remote

Job ID: 25105677

Overview

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 brings the customer and the patient to the center of everything we do. We simplify and streamline our work to make Syneos Health easier to work with and for. Discover what our 29,000 employees across 110 countries already know:

Why Syneos Health

We are passionate about developing our people, through career development and progression; supportive line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. We continuously build the company we want to work for and our customers want to work with, by fostering diversity and inclusion.

Job Responsibilities

• Perform site qualification, site initiation, interim monitoring, site management activities and close‐out visits (on‐site or remotely) ensuring regulatory, ICH‐GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.
• Verify informed consent procedures and protect confidentiality, assess safety and data integrity risks, and communicate/escalate serious issues to the project team.
• Conduct source document review, query resolution, and ensure electronic data capture compliance, supporting effective data review and capture.
• Manage investigational product inventory, reconciliation, storage, and security, verifying dispensing and administration according to protocol.
• Review Investigator Site File accuracy, reconcile with the Trial Master File, and educate sites on archiving requirements.
• Document activities via letters, reports, communication logs; support recruitment, retention and awareness strategies; enter data into tracking systems.
• Understand project scope, budgets, and timelines; manage site‐level activities and communications to meet objectives and deliverables.
• Act as primary liaison with site personnel and collaborate with Central Monitoring Associate, ensuring training and compliance.
• Prepare for investigator and sponsor meetings; attend global clinical monitoring/project staff meetings and training sessions.
• Provide guidance toward audit readiness and support audit preparation and follow‐up.
• Maintain knowledge of ICH/GCP and relevant regulations; complete required training.
• For Real World Late Phase, use the Site Management Associate II title and train junior staff as needed.

Qualifications

• Bachelor's degree or RN in a related field, or equivalent combination of education, training and experience.
• Knowledge of Good Clinical Practice/ICH Guidelines and applicable regulatory requirements.
• Good computer skills and ability to embrace new technologies.
• Excellent communication, presentation and interpersonal skills.
• Ability to manage required travel of up to 75% on a regular basis.
• US‐only: compliance with required medical and personal information for site access.

Benefits

The benefits for this position may include a company car or car allowance, medical, dental and vision health benefits, company match 401(k), participation in Employee Stock Purchase Plan, eligibility to earn commissions/bonus based on performance, and flexible PTO and sick time. Eligibility for paid sick time may vary by state.

Salary Range

The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on qualifications, skills, competencies and proficiency.

Get to Know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and over 200 studies across 73,000 sites and 675,000+ trial patients. Learn more at http://www.syneoshealth.com.

Additional Information

Tasks, duties and responsibilities listed are not exhaustive. The company may assign additional tasks at its discretion. Equivalent experience, skills or education may be considered. The company complies with all applicable legislation and the Americans with Disabilities Act, and provides reasonable accommodations.

Summary

Roles within Clinical Monitoring/CRA ensure integrity of clinical research studies by monitoring data and processes from a centralized location. Responsibilities include remote monitoring to verify compliance, risk‐based monitoring, query resolution, and working with site teams to implement quality tools. Syneos Health is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status. If you need a reasonable accommodation during the application process, contact jobs@syneoshealth.com.