Syneos Health® is a premier biopharmaceutical solutions organization designed to accelerate customer success. We’re dedicated to transforming clinical, medical affairs, and commercial insights into real-world outcomes that address modern healthcare challenges. Our mission is to simplify and streamline clinical development while focusing on the customer and the patient.
About Syneos Health
With a robust workforce of over 29,000 employees across 110 countries, Syneos Health stands at the forefront of clinical development. We take pride in fostering a Total Self culture, championing diversity of thoughts, backgrounds, cultures, and perspectives. This culture strengthens our commitment to creating an inclusive workplace where every employee feels they belong. Our aim is not only to enhance our collaborative efforts with clients but also to refine the environment we create for our employees.
Job Description: Senior Clinical Research Associate I
As a Senior Clinical Research Associate I, you will play a pivotal role in the execution and management of clinical trials, particularly in the oncology and cardiovascular disease (CVD) therapeutic areas. Your responsibilities will include:
- Conducting site qualification, initiation, interim monitoring, management, and close-out visits, either remotely or on-site, ensuring compliance with regulatory, ICH-GCP, and protocol guidelines.
- Verifying informed consent processes and assessing factors that impact subject safety and clinical data integrity.
- Conducting Source Document Reviews and ensuring the accuracy of data in Clinical Report Forms (CRF).
- Regularly reviewing the Investigator Site File (ISF) for compliance and completeness against the Trial Master File (TMF).
- Serving as a liaison with project site personnel to ensure compliance and efficient communication.
- Supporting site recruitment, retention, and awareness strategies throughout the study lifecycle.
- Documenting activities meticulously and ensuring compliance with audit standards.
Qualifications
To be successful in this role, you should possess:
- Minimum 5 years of experience in the oncology and CVD therapeutic areas.
- A Bachelor’s degree or RN in a relevant field, or an equivalent combination of education, training, and experience.
- Knowledge of Good Clinical Practice (GCP), ICH Guidelines, and applicable regulatory requirements.
- Strong computer skills and a readiness to embrace new technologies.
- Excellent communication, presentation, and interpersonal skills, along with basic critical thinking skills.
- The ability to manage travel commitments of up to 75% regularly.
