Summary:

This is an exciting opportunity to work within a fast-paced, busy environment in the pharmaceutical, biotechnology, and medical device industries. As a Clinical Trial Assistant (CTA) you must assist the clinical research teams in ensuring the most effective and efficient conduct of clinical research studies by providing administration and project tracking support.

Qualifications:

To provide general administrative support to the Clinical Operations Department and assistance to the Project Manager(s) and Project Director(s).

• To assist the Clinical Operations teams in completing all required tasks to meet departmental and project goals.
• To support the Clinical Operations teams with ongoing conduct of studies.
• To be familiar with ICH GCP, and appropriate regulations.
• To be familiar with the roles of the Clinical Research Associates (CRA)
• To assist project teams with study-specific documentation and guidelines.
• To set up, organize, and maintain clinical study documentation (e.g. Main Study Files, CRFs, etc.) including preparation for internal/external audits, final reconciliation, and archival.
• To process Data Collection Forms i.e. log in, tracking, and quality control as appropriate for each study.
• To assist in quality control audits of clinical study documentation (e.g. Main Study Files, CRF Files, Monitoring Files, etc.).
• To coordinate ordering/dispatch and tracking of trial materials (e.g. CRFs, diary cards, lab supplies, drug supplies) as appropriate.
• To contact clinical sites for specific requests (e.g., enrollment updates, missing documentation, meeting arrangements, etc.).
• To assist in the tracking and distribution of safety reports.
• To attend project team meetings and generate meeting minutes.
• To assist the Project Manager and project team with Investigator Meeting coordination, activities preparation, and generating meeting minutes.
• Other duties as assigned

JOB FUNCTIONS/RESPONSIBILITIES

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

• Either relevant work experience or High School Diploma (or equivalent).
• Research or health care-related academic or work experience preferable.
• Good organizational skills, ability to manage multiple tasks, and meticulous attention to detail.
• Good written and verbal communication skills.
• Good written and spoken English.
• Computer literacy: e.

g. Microsoft Word, Excel, PowerPoint, Outlook.