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

Arbutus Biopharma

Location:
Warminster, PA
Posted Date:
8/14/2017
Position Type:
Full time
Job Code:
17-24
Salary:
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.

Requirements


•   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
e-mail: careers@arbutusbio.com
web: arbutusbio.com


How to Apply:
We invite you to send your cover letter and resume in PDF format, to careers@arbutusbio.com. 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