Clinical Trial Associate - FSP

Job Summary:

The Clinical Trial Associate is a highly motivated person with excellent computer skills, who is highly attentive to details, has strong organizational skills, and able to communicate effectively in a fast paced environment. Major responsibilities for this position include maintenance of informational databases and program tracking reports, participate in coordination of clinical trial related activities, authoring of study operations manuals, budgetary oversight and tracking, and providing general program support in a team setting to ensure the successful execution of clinical trial tasks and deliverables according to project timelines. Duties may include, but are not limited to, subject tracking, assembly, review, quality control, and tracking of regulatory documents, maintenance and tracking of study materials (including investigational drug), generation and distribution of meeting agendas and minutes in addition to other activities.

Key Responsibilities:

• Effectively and efficiently interact with internal, clinical site and vendor personnel.
• Have the interest and ability to expand knowledge of clinical trial management procedures and regulatory submission requirements.
• Learn health care authority regulations and guidelines, and apply to daily activities.
• Perform day-to-day activities based on Standard Operating Procedures and Good Clinical Practice (GCP).
• Learn and execute defined tasks while working closely with others.
• Assist with in-house coordination of activities related to conduct of clinical trials.
• Demonstrate problem-solving skills, including the identification of problems and proposed solutions, in consultation with more senior team members.
• Possess good verbal skills and seek information when needed.
• Seek opportunities to learn and be receptive to constructive feedback.
• Benefit from close supervision but be willing to work independently.
• Receive guidance on clinical development process and the role operations plays in that process.
• Track progress across multiple programs and communicate this to internal and external stakeholders.
• Organize trial and program related team meetings, associated agendas, and generate meeting minutes, including tracking of action items.
• Become familiar with and assist in maintaining clinical invoice tracking and other budget databases for multiple projects, generate periodic reports on status of payments and other database reports, and resolve payment inquiries from investigator sites.
• Maintain other informational databases for clinical trial status throughout the life of a clinical program.

Requirements:

• BS/BA degree in healthcare / scientific field preferred
• Minimum of 1 year work experience in the clinical research industry
• Some experience working in a contract research organization and/or clinical trial environment is preferred
• Travel as needed, although requirements are minimal