About the job
Job Summary:
Are you eager to join a dedicated clinical trial team committed to improving patient lives? If so, your next career opportunity awaits! Our Clinical Support Specialists play a crucial role in advancing innovative therapies for patients worldwide. We prioritize the needs of our patients and clients, ensuring that our work is of the highest quality while fostering an environment where our employees can thrive and enjoy their work while contributing to the patient community.
At Precision Medicine Group, our diverse teams combine unique perspectives to deliver unparalleled client experiences, where every voice is pivotal in achieving shared goals. We value individual growth and encourage our team members to drive their careers forward in a supportive environment.
About the Role:
- Assist teams with feasibility and investigator recruitment initiatives.
- Facilitate or lead site startup activities, including:
- Establishing site-level milestones for timely activation.
- Adhering to submission and approval timelines.
- Conducting reviews, validations, tracking, and filing of essential documents for investigational sites, including following up on any missing or invalid documents.
- Reviewing Informed Consent.
- Preparing and submitting Central Ethics Committee applications and supporting sites with Local Ethics Committee submissions as needed.
- Manage eTMF and oversee study-related mailboxes, ensuring the creation, maintenance, and closeout of the essential client deliverable, TMF.
- Provide administrative support for project-related activities, such as:
- Maintaining team training.
- Coordinating with study supply and site binder vendors.
- Documenting meeting minutes.
- Mentor and assist in the development of junior Clinical Support Specialists.
