Clinical Research Coordinator - Office Based
Company: ICON Strategic Solutions
Location: Providence
Posted on: January 24, 2023
Job Description:
ICON plc is a world-leading healthcare intelligence and clinical
research organization. From molecule to medicine, we advance
clinical research providing outsourced services to pharmaceutical,
biotechnology, medical device and government and public health
organizations. With our patients at the center of all that we do,
we help to accelerate the development of drugs and devices that
save lives and improve quality of life. Our people are our greatest
strength, are at the core of our culture, and the driving force
behind our success. ICON people have a mission to succeed and a
passion that ensures what we do, we do well.The Clinical Research
Coordinator role is an office based position in Cambridge, MA. This
role will include the following responsibilities:
- Entry of data into Clinical Trial Management Software
(CTMS).
- Generation of reports in CTMS.
- Assist Clinical Research Associates with the following clinical
study related activities including but not limited to:
- Support Institutional Review Board submissions / document prep
and correspondence (initial, amendments, renewals).
- Support site / study training.
- Assist in preparation of site training / study initiation
materials.
- Create and maintain study binders.
- Contact and coordinate study participant recruitment and
enrollment for internal trials, including:
- Retain documentation necessary for this process.
- Initiate, coordinate, and manage activities associated with
external patient trials and focus group meetings, including
locating participants, securing meeting locations, developing trial
procedures, and designing survey materials.
- Conduct quality audits through monitoring internally and
externally (remotely or onsite) to ensure compliance with US or
international regulations.
- Maintain traceability and accountability of study devices.
- Follow procedures to order study equipment.
- Assist with device labeling, modified product process, set-up
and shipments.
- Manager return and disposition of study equipment.
- Manager (generate and track) Purchase Orders (POs) to
facilitate study payments to sites and vendors.
- Data Entry and Validation.
- User Assessment Testing (UAT) of Electronic Data Capture (EDC)
system develop Excel spreadsheets for data capture validate / audit
per validation plan.
- Initiate and track requests for legal agreements.
- Support the timely and accurate compilation of: all study data,
study reports, including SAP file / document entries.
- Maintain professional relationships with internal
associates.Qualifications
- Bachelors degree preferred
- Minimum of 2 years in clinical research or healthcare related
industry, or equivalent combination of education and experience;
site monitoring experience a plus
- Experience in scientific discipline and multiple therapeutic
areas preferred
- Experience/training in the following areas: GxP Regulations,
ICH Guidelines, Good Quality Practices, 21 CFR Part 11 and Computer
Security (Part 11, Electronic Records; Electronic Signatures-Scope
and Application; 21 CFR 11 and Industry Guidance), HIPAA, Drug
Development and Approval Process
- Proficiency in MS Office including Word, Excel, and
PowerPointBenefits of Working in ICON:Our success depends on the
knowledge, capabilities and quality of our people. Thats why we are
committed to developing our employees in a continuous learning
culture one where we challenge you with engaging work and where
every experience adds to your professional development.At ICON, our
focus is to provide you with a comprehensive and competitive total
reward package that comprises, not only an excellent level of base
pay, but also a wide range of variable pay and recognition
programs. In addition, our best in class employee benefits,
supportive policies and wellbeing initiatives are tailored to
support you and your family at all stages of your career - both
now, and into the future.ICON, including subsidiaries, is an equal
opportunity and inclusive employer and is committed to providing a
workplace free of discrimination and harassment. All qualified
applicants will receive equal consideration for employment without
regard to race, color, religion, sex, sexual orientation, gender
identity, national origin, disability or protected veteran
status.If, because of a medical condition or disability, you need a
reasonable accommodation for any part of the application process,
or in order to perform the essential functions of a position,
please let us know.
Keywords: ICON Strategic Solutions, Providence , Clinical Research Coordinator - Office Based, Administration, Clerical , Providence, Rhode Island
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