Clinical Operations Administrative Associate

Job Description

JOB DESCRIPTION SUMMARY

The Clinical Operations Administrative Associate will coordinate and execute back-office and administrative tasks that support planning, execution, and progress of Clinical studies under GCP principles, being responsible for shipments, supplies (incl. study documentation), and overall administrative support in the Clinical Research department.

The Clinical Operations Administrative Associate serves an integral function within the Clinical Research team, ensuring smooth operation of day-to-day activities. This individual will directly handle tasks that provide crucial support to our scientists, monitors, and research associates. This position requires strong attention to detail and excellent organizational and communication skills.

MAJOR ACTIVITIES AND RESPONSIBILITIES

• Assist scientists, monitors, and clinical research associates with preparation for upcoming studies (ordering clinical trial supplies, creating notebooks, etc.) and/or liaises with third party vendors to complete study preparation tasks in compliance with the study protocol, Veterinary International Conference on Harmonization (VICH)/Good Clinical Practice (GCP), Sponsor Standard Operating Procedures (SOPs) and applicable regulatory requirements.

• Support maintenance and archiving of paper and electronic study documentation as needed.

• Maintain investigator database and applicable tracking tools.

• Assist with preparation of legal and/or administrative study documents.

• Maintain file storage room by ordering & managing office supplies, shipping/receiving packages & mail, and ensuring the office environment is organized and well-maintained.

• Support maintenance of team SharePoint site.

• Assist with data entry tasks and quality control (QC) of data as needed.

• Assist with the preparation and the reviewing of submissions to regulatory bodies.

• Assist with implementation of improvements in the clinical research and development processes.

• Assist scientists and monitors with document formatting as needed.

• Bring elucidation to routine, yet complicated, business processes, helping to identify possible solutions as necessary.

QUALIFICATION PROFILE

Education:

Bachelor’s degree or equivalent is preferred.

Skills Required:

• Meticulous record keeping skills.

• Extensive experience with Microsoft Office and Adobe Acrobat.

• Accuracy and attention to detail in all aspects of work.

• Effective organizational skills in supporting multiple functions.

• Ability to meet deadlines and independently/effectively prioritize work.

• Ability to independently anticipate and solve problems that arise.

• Consistent delivery of commitments in a fast-paced work environment.

• Team player with a “can-do” attitude, flexibility, and adaptability.

• Willingness to learn.

• Good written and oral command of English language.

• Good communication skills.

Competencies Required:

• Proven ability to handle and prioritize many simultaneous assignments and drive results.

• 1+ year of administrative background, preferably in a corporate environment and/or pharmaceutical industry.

• Alternatively, candidates with a High School Diploma or Associate's degree with …