Clinical Trial Associate
Company: Precision For Medicine
Location: Norton
Posted on: June 23, 2022
Job Description:
Position Summary
The Clinical Trial Associate will provide support to the Clinical
Operations and Project Manager through the performance of
project-specific tasks whereby contributing to the overall
management of clinical trials.
Essential functions of the job include but are not limited
to:
- Assist clinical study and project management teams with all
aspects of study site management from study start-up to close-out
on various studies simultaneously
- Assist with preparations of essential document templates,
binders, collection, and review. Perform study tracking to ensure
study files are current, accurate and complete
- Create and maintain central study files, including the
electronic trial master file (eTMF) or TMF, for the duration of the
study including assisting in file review and reconciliation for
audits, in addition to preparing study files for archival
- Assist in planning, organizing and executing project-specific
meetings including but not limited to Precision-Client meetings,
Site-Precision meetings, and PI meetings
- May be responsible for collection kit/supply assembly, tracking
and shipping
- Prepares correspondence, spreadsheets and presentations
utilizing Microsoft Office Suite, for project specific studies.
Develop and maintain project specific plans, documents and tools
for the Clinical Team
- Take initiative to support the Clinical Operations team to
ensure timely, successful activation of trial sites according to
time, quality/scope and budget parameters
- Collaborate with the Project Manager (PM) to facilitate
cross-functional team and Client communications for proactive,
study-wide problem solving regarding study progress and trial
issues during the study
- Liaise with Internal and External customers/vendors to meet
project specific goals and Client deliverables
- Support Clinical Team Manager/Lead in the management of
investigational sites to ensure compliance with the trial protocol,
ICH-GCP and applicable regulations, as required by certain
projects
- Performs all duties in accordance with Precision's SOPs,
government regulations and Good Clinical Practices (GCP) and Good
Documentation Practices (GDP)
- Carry out other duties/projects as assigned
Qualifications
Minimum Required:
- Bachelor's degree in a clinical, scientific, or related
field
- Minimum of 2 years related experience, or equivalent
combination of education and apprenticeship
Other Required
- Experience with Microsoft Office Products (Outlook, Word,
Excel, PowerPoint)
- Able to read and interpret documents such as safety rules,
operating and maintenance instructions and procedure manuals; to
write routine reports and correspondence; to speak effectively
before groups of customers or employees of organization
- Must possess a customer service demeanor; demonstrate
flexibility, teamwork, and a keen attention to detail
- Understands clinical trials methodology, including a working
knowledge of protocols and indications being studied
- Demonstrates knowledge of ICH-GCP, and regulatory guidance, as
well as the ability to implement
- Resolves project related problems and prioritize workload to
meet deadlines with little support from management
- Exhibits high self-motivation, and is able to work and plan
independently as well as in a team environment
- Demonstrates an acceptable degree of professionalism, as
evidenced by punctuality, ability to deliver on commitments, an
understanding of the service culture and positive interactions with
customers and teammates, including good interpersonal skills
- Excellent communication skills (verbal and written) and
collaborative working style Possesses practical knowledge of IT
tools and systems in use on project team, particularly the MS
Office suite, version 2010 or more recent
- Ability to fulfill the clinical operations and data management
roles with Precision Biospecimen Solutions
- Must be able to read, write, speak fluently and comprehend the
English language
Preferred
- Continuing education courses toward Master's Degree in a
clinical, scientific, or related field preferred
Any data provided as a part of this application will be stored in
accordance with our Privacy Policy .
Precision Medicine Group is an Equal Opportunity Employer.
Employment decisions are made without regard to race, color, age,
religion, sex, sexual orientation, gender identity, national
origin, disability, veteran status or other characteristics
protected by law. - 2020 Precision Medicine Group, LLC
If you are an individual with a disability and require a reasonable
accommodation to complete any part of the application process, or
are limited in the ability or unable to access or use this online
application process and need an alternative method for applying,
you may contact Precision Medicine Group at
QuestionForHR@precisionmedicinegrp.com .
Keywords: Precision For Medicine, Brockton , Clinical Trial Associate, Healthcare , Norton, Massachusetts
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