Our mission is to accelerate life-saving treatments to market, maximizing return on investment for healthcare clients.
We put the customer and patient at the center of everything we do. We continuously seek ways to simplify and streamline our work, making us easier to work with and for.
We offer a collaborative environment where you will innovate as a team to help our customers achieve their goals.
We are passionate about changing lives, driven by a global community of 29,000 employees across 110 countries.
Why Choose Us?
* We invest in career development through training programs, peer recognition, and rewards.
* We promote a culture of authenticity, embracing diversity of thoughts, backgrounds, cultures, and perspectives.
* We create a workplace where everyone feels like they belong.
Responsibilities
* Conduct site qualification, initiation, interim monitoring, site management activities, and close-out visits (on-site or remotely) ensuring regulatory compliance.
* Verify informed consent processes and documentation for each subject/patient, protecting confidentiality and assessing factors affecting subject safety and data integrity.
* Assess site processes, conduct source document review, verify CRF data accuracy and completeness, apply query resolution techniques, and utilize hardware/software to support data review.
* Perform investigational product inventory, reconciliation, and storage/security reviews.
* Routinely review the Investigator Site File (ISF) for accuracy, timeliness, and completeness, reconcile with the Trial Master File (TMF), and ensure archiving of essential documents.
* Document activities via letters, logs, trip reports, and other project documents.
* Understand project scope, budgets, and timelines, manage site-level activities and communications to meet objectives and deadlines.
* Act as primary liaison with study site personnel, ensure sites and team members are trained and compliant with requirements.
* Maintain working knowledge of ICH/GCP Guidelines, relevant regulations, and company SOPs, completing required training.
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 other applicable regulatory requirements.
* Strong computer skills and ability to learn new technologies.
* Excellent communication, presentation, and interpersonal skills.
* Ability to travel up to 75% on a regular basis.