Clinical Trial Associate

THE ROLE

Reporting to our Director of Clinical Operations, the Clinical Trial Associate will participate in planning and assisting in managing the conduct of clinical trials in accordance with company policies and procedures and applicable regulations. The role may include some travel when conditions allow.

THE RESPONSIBILITIES

Prepares and maintains documents and files such as clinical study files, regulatory binders,

and operations manuals for clinical sites (i.e., investigators 1572s, informed consent form,

• protocol and investigators brochure).Under general supervision collects, processes and tracks investigator sites and regulatory documents required by the FDA, other regulatory authorities, and IRBs/ECs, as necessary across multiple studies using manual tools (such as spreadsheets) and / or a CTMS system.
• Coordinates, processes, and tracks shipments (i.e., supplies, study-related materials, etc.)
• Serves as a point of contact for study sites and contract monitors for clinical supplies,
• document collection and preparation for close-out.
• Responsible for the filing of documents into the TMF (paper or electronic).
• Assists with the quality review of documentation e.g., ICFs, regulatory green light packages.
• Attends study and Departmental meetings, taking meeting minutes where necessary.
• Has some understanding of the science behind Clinical Research, observes and gains
• exposure to clinical monitoring which may include attendance at site visits and support of
• investigator and other professional meetings and activities.
• Capable of handling additional task with little supervision.
• Follows ICH-GCP and FDA regulations and contributes to GCP inspection-readiness activities.
• Travel up to 5%.

• THE QUALIFICATIONSBA/BS in equivalent field with a year or more of experience in Clinical Operations or equivalent experience without degree.
• Excellent interpersonal, organizational, problem-solving, and written/verbal. communication/influence skills.
• May be proficient in electronic systems e.g., eTMF or CTMS.
• Proficiency in MS Word/Excel/Project.
• Experience with electronic data capture/reviewing/interpreting data desired.