Sr CRA I- Oncology/ Rare Disease (Midwest US)

Syneos Health/ inVentiv Health Commercial LLC; Missouri; On-site; USD 62,000 - 146,000; Full time

Job summary

Join a leading biopharmaceutical solutions organization that is dedicated to accelerating customer success and improving lives. As a Senior Clinical Research Associate, you will play a crucial role in site management, ensuring compliance with regulations and protocols while collaborating with passionate problem solvers. This dynamic position offers opportunities for career growth, a supportive culture, and the chance to make a meaningful impact in the clinical research field. With a commitment to diversity and inclusion, you'll thrive in an environment where your contributions truly matter.

Benefits

Company car or allowance

Health benefits

401k match

Stock purchase plans

Flexible PTO

Qualifications

• Bachelor's degree or RN in a related field or equivalent experience.
• Knowledge of GCP/ICH guidelines and regulations.

Responsibilities

• Perform site qualification, initiation, monitoring, and close-out visits.
• Manage project scope, budgets, timelines, and communicate effectively.
• Support site activities throughout the study lifecycle.

Skills

GCP/ICH guidelines knowledge

Excellent communication skills

Strong computer skills

Critical thinking abilities

Education

Bachelor's degree in a related field

Registered Nurse (RN)

Job description

Description

Senior Clinical Research Associate I

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 around the customer and the patient. We strive to simplify and streamline our work to make Syneos Health easier to work with and for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team 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, supportive management, training, peer recognition, and rewards.
• We foster a Total Self culture where you can be authentic. We are committed to diversity and creating a sense of belonging.

Job Responsibilities

• Perform site qualification, initiation, monitoring, management, and close-out visits (on-site or remotely), ensuring compliance with regulations, ICH-GCP, and protocols. Evaluate site performance and escalate issues as needed.
• Verify informed consent processes, protect confidentiality, and assess safety and data integrity issues.
• Assess site processes, review source documents, verify data accuracy, resolve queries, and support electronic data capture compliance.
• Manage investigational product inventory, reconciliation, and storage, ensuring proper dispensing and compliance.
• Review Investigator Site Files, ensure document archiving, and document activities appropriately.
• Manage project scope, budgets, timelines, and communicate effectively with site personnel and project teams.
• Participate in meetings, lead training for junior staff, and support audit readiness.
• Support site activities throughout the study lifecycle, including for Real World Late Phase studies, and collaborate with regulatory teams.

Qualifications

• Bachelor's degree or RN in a related field or equivalent experience.
• Knowledge of GCP/ICH guidelines and regulations.
• Strong computer skills and adaptability to new technologies.
• Excellent communication and interpersonal skills, with basic critical thinking abilities.
• Willingness to travel up to 75% regularly.

Additional Information

Tasks and responsibilities may vary; the company reserves the right to assign other duties. Qualifications may be considered equivalent. The company complies with applicable laws and promotes an inclusive environment. Benefits include a company car or allowance, health benefits, 401k match, stock purchase plans, bonuses, and flexible PTO. Salary ranges from $62,000 to $145,100, depending on qualifications. We encourage vaccination and comply with relevant health policies.