JOB SUMMARY

The Clinical Trial Associate will be responsible supporting the clinical study team with administrative duties included but not limited to: collecting and reviewing essential regulatory documents, maintaining the trial master file and study status tracking.

RESPONSIBILITIES

• Timely and accurate review of essential regulatory documents (1572s, Informed Consents, Financial Disclosures, CVs) including communication of needed changes, as required, to PM, LCRA or site staff.
• Central IRB submission assistance.
• Tracking of study status.
• Maintenance of Clinical Trial Management System (CTMS).
• Creation, maintenance and archiving of trial master file (TMF).
• Shipment of study supplies.
• Meeting set-up and organization.
• Draft study meeting agendas/minutes.
• Liaise with Clinilabs’ clients as required per study.
• Site payment reconciliation assistance.
• Other study related administrative duties.
• Assist with training of new Clinical Trials Assistants.
• Participate in Clinical Operations departmental initiatives.

 Salary range between $70,000 - $73,000.  Final compensation is based on skills, experience, location, and overall expertise. 

TRAVELING

From time to time, travel between company offices may be required, as needed.

• High School diploma or equivalent a must. Some college or technical experience required. Bachelor’s degree is preferred.
• At least 3-4 years of work experience in a clinical research role within a Pharmaceutical, Biotechnology Industry and/or CRO environment. In lieu of clinical research experience, at least 6 years in a health care setting.
• Knowledge of GCP guidelines, FDA guidelines, medical terminology and clinical trial processes.
• Strong organizational skills with attention to details.
• Excellent communication skills (written and verbal).
• Strong computer skills (Word, Excel, Document management systems).
• Ability to manage and prioritize multiple tasks and projects.
• Ability to adapt to a fast-past and changing environment.
• Excellent interpersonal skills, ability to work in teams and in close collaboration with others.
• Ability to work independently and assist with improving the Clinical Trial Associate function and tools used by the person in this role.
• Ability to support Project Managers and drive the study start-up process, including feasibility, Informed Consent and TMF set-up.