Associate, Clinical Operations - Warminster, PA | Biospace
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Associate, Clinical Operations

Arbutus Biopharma

Warminster, PA
Posted Date:
Position Type:
Full time
Job Code:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Associate, Clinical Operations,

Job Description

About us:

At Arbutus we have a vision: to cure chronic Hepatitis B virus (HBV).  We have a dedicated and innovative team and we are uniquely positioned to transform the HBV treatment landscape.  We are developing a portfolio of drug candidates with multiple mechanisms of action that we believe will result in a combination therapy to cure HBV.  Arbutus Biopharma has offices and research facilities in Burnaby, Canada and Warminster, Pennsylvania, USA.

About the role:

Arbutus has an opportunity for a Clinical Operations Associate to join our team in Warminster.  Reporting to a Director, Clinical Operations, the Clinical Operations Associate will provide reliable, high level support to our clinical operations department in the execution of clinical studies.

If you are looking to join a team with a proven track record in drug discovery and development, and are as passionate as we are, we want to hear from you.

Responsibilities will include:

•   Develops and maintains Clinical filing and documentation systems including:
o   set-up and maintenance of Arbutus’ electronic trial master files;
o   working with key stakeholders to maintain and QC the TMFs across all files; and
o   managing all study specific and/or departmental files.
o   QC study start-up documents prior to dosing to ensure required documents have been collected.  
•   Assists Clinical Operations team with developing and finalizing project infrastructure including project documents, budgets and project plans.
•   Responsible for processing of invoices and tracking of project related costs and expenditures.
•   Performs document reviews with integration of data from multiple sources.
•   Liaises with CRO’s, study sites, KOL’s, investigators, etc. in relation to the conduct of Clinical studies.
•   Creates monthly metrics reports, study summaries and update trackers as needed.
•   Updates project plans other clinical operations documents as necessary.
•   Prepares clinical study kits and other materials for distribution to clinical sites.
•   Performs literature searches as necessary.
•   Organizes and verifies travel, accommodation, and meeting arrangements for assigned clinical staff and related study team members.
•   Handles various administrative responsibilities for the Clinical Operations team, including:
o   making meeting arrangements;
o   word processing and database entry;
o   preparing expense reports, photocopying, scanning and compilation work; and
o   preparing agendas for meetings and taking meeting minutes.
•   Other related duties as assigned.


•   Bachelor’s degree (preferred) or recognized Diploma and at least 5 years of related clinical research experience or equivalent combination of education and experience.
•   Good knowledge of ICH-GCP guidelines, and applicable regulations.
•   A good understanding of the drug development process with an ability to work on complex clinical research projects.
•   Strong organizational and personal effectiveness skills with an ability to prioritize work assignments, seek information, and meet timelines in a fast-paced environment.
•   Demonstrated ability to work effectively in teams and manage multiple tasks with competing priorities.
•   Excellent attention to detail with a strong commitment to standards and quality.
•   Proven flexibility, adaptability and professional integrity.
•   Must be able to multi-task and prioritize work effectively.
•   Strong interpersonal, oral and written English communication skills.
•   Competency in Microsoft Word, Excel and PowerPoint required; experience in MS Project beneficial.
•   Establishes and maintains effective, professional, collaborative working relationships with staff at all levels of the organization.
•   Experience with assisting in the set-up of Investigator meetings is a plus.

Contact Information:
701 Veterans Circle
Warminster, PA 18974

How to Apply:
We invite you to send your cover letter and resume in PDF format, to Please ensure your submission is in PDF format (ideally in one document) indicating the position title and reference number in the subject line of the email (“Clinical Operations Associate #17-24”).

About your Application:
At Arbutus we value diversity and encourage applications from all qualified candidates.  

We greatly appreciate your interest in being a part of our team; however, because of the volume of resumes received, we are only able to contact you should you be considered for a position.  We will keep your resume in our database for one year, and contact you should a position that matches your skills become available.

Search Words:  Clinical Trials Assistant; CTA