Clinical Research Associate I
2 days ago
Job Title: Clinical Research Associate I
Job Summary:
We are seeking a highly motivated and detail-oriented Clinical Research Associate I to join our team at Syneos Health. As a Clinical Research Associate I, you will be responsible for performing site qualification, site initiation, interim monitoring, site management activities, and close-out visits to ensure regulatory, ICH-GCP, and protocol compliance. This is a fantastic opportunity to work with a leading biopharmaceutical solutions organization and contribute to the acceleration of customer success.
Key Responsibilities:
Perform site qualification, site initiation, interim monitoring, site management activities, and close-out visits to ensure regulatory, ICH-GCP, and protocol compliance.
Verify the process of obtaining informed consent has been adequately performed and documented for each subject/patient.
Assess factors that might affect subject/patient safety and clinical data integrity at an investigator/physician site.
Conduct Source Document Review of appropriate site source documents and medical records.
Apply query resolution techniques remotely and on site, and provide guidance to site staff as necessary.
Utilize available hardware and software to support the effective conduct of the clinical project data review and capture.
Verify site compliance with electronic data capture requirements.
May perform investigational product (IP) inventory, reconciliation, and reviews storage and security.
Document activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan.
Support subject/patient recruitment, retention, and awareness strategies.
Enter data into tracking systems as required to track all observations, ongoing status, and assigned action items to resolution.
Qualifications:
What we're looking for:
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 other applicable regulatory requirements.
Must demonstrate good computer skills and be able to embrace new technologies.
Excellent communication, presentation, and interpersonal skills.
Ability to manage required travel of up to 75% on a regular basis.
Why Syneos Health:
We are passionate about developing our people, through career development and progression; supportive and engaged 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. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
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