Clinical Trial Associate
At SRG, we create meaningful connections that empower individuals and businesses to shape tomorrow’s world.
Working as part of the SRG team, you will work with our client which are Pharmaceutical or Bio-Pharmaceutical companies to ensure work quality and accuracy for our client in the Bio Pharmaceutical Industry.
The Clinical Trial Associate (CTA) is responsible for ensuring logistical support for clinical trials throughout study start-up, conduct and close-out, under the supervision of a study manager. The CTA functions with moderate supervision, collaborating with inter- and intra-departmental resources and site personnel to ensure quality deliverables, project timelines and needs are being met.
- Collaborate closely with the assigned study manager to effectively support assigned studies
- Support and interact directly with vendors involved in the conduct of studies
- Communicate with sites regarding trial start-up, conduct and close-out activities
- Collect and review regulatory documents from clinical sites - for completeness and accuracy
- Organize and maintain accurate tracking systems and tools to support the conduct of a clinical study from start-up to close-out
- Manage and maintain clinical and non-clinical supplies
- Provide in-house support to field CRAs/monitors
- Draft agendas and record minutes from study meetings
- Management and reconciliation of the Trial Master File
- Management of study newsletter development process
- Perform general administrative duties for the assigned project team such as photocopying and scanning, mass mailing and submission of documents to Records Repository
- Participate in Clinical Operations meetings and training initiatives, project team meetings, and maintain relationships with other departments and clients
- Interact directly with CROs, and CRO personnel, when CROs are involved in studies
- Bachelor’s Degree or equivalent work experience required
- Professional demeanor, strong communication skills (both written and verbal) and strong interpersonal skills including diplomacy
- Must be able to prioritize multiple tasks, plan proactively and accomplish goals using well-defined instructions and procedures
- Strong analytical and problem-solving skills
- Relies on experience and judgment to plan and accomplish goals
- Working knowledge and experience with Word, PowerPoint, and Excel
- A minimum of 3 - 5 years of accumulated clinical trial support experience, which may include Site, CRO, Pharma, Biotech, and/or IRB related experience
- GCP and regulatory knowledge including FDA and ICH regulations
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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