Job Description
We are seeking a skilled and dedicated professional to perform site qualification, site initiation, interim monitoring, site management activities, and close-out visits. This role requires strong analytical skills and the ability to evaluate overall performance of sites and provide recommendations for site-specific actions.
The ideal candidate will have a bachelor's degree in a related field or equivalent combination of education and experience. Strong knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements is essential.
This role also involves verifying informed consent processes, maintaining confidentiality, and assessing factors that might affect subject/patient safety and clinical data integrity. The successful candidate will be able to work independently and as part of a team, with excellent communication and interpersonal skills.
Responsibilities:
* Performs site qualification, site initiation, interim monitoring, site management activities, and close-out visits
* Evaluates overall performance of sites and provides recommendations for site-specific actions
* Verifies informed consent processes and maintains confidentiality
* Assesses factors that might affect subject/patient safety and clinical data integrity
* Collaborates with study site personnel and Central Monitoring Associate to ensure all assigned sites and project-specific site team members are trained and compliant with applicable requirements
* Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings
* Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions
Requirements:
* Bachelor's degree in a related field or equivalent combination of education and experience
* Strong knowledge of GCP guidelines and regulatory requirements
* Excellent analytical, communication, and interpersonal skills
* Ability to manage required travel of up to 75% on a regular basis
Benefits
Our company offers a dynamic and supportive work environment, with opportunities for career growth and development. We prioritize our employees' well-being and offer competitive compensation and benefits packages.
About Us
We are a global healthcare company dedicated to improving patients' lives around the world. Our team of professionals works collaboratively to deliver innovative solutions and therapies to those who need them most.
How to Apply
If you are a motivated and detail-oriented individual with a passion for clinical research, we encourage you to apply for this exciting opportunity. Please submit your resume and cover letter to [insert contact information].