Clinical Trial Associate

Description

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.

Requirements

• •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.