CRA III/CRA Supervisor/Manager
Location: New England Maine
Description: FPC is in need of CRA III/CRA Supervisor/Manager right now, this vacancy will be placed in Maine. For detail informations about this vacancy opportunity kindly read the description below. A senior CRA, Level III has several years of previous relevant experience and can carry out the task that are required with little supervision. This role will also have supervisory responsibility for a ! staff of three CRA’s at varying levels. This role reports directly to the Global VP of Clinical and will collaborate with the team regularly, excellent communication skills are a must.
GENERAL RESPONSIBILITIES:
Ø Supervisory responsibilities for staff of three CRA’s.
Ø Ensure proper updates and logs are available for management review
Ø Coordinate team efforts as needed, considering management priorities and timelines
Ø Review contracts, budgets - working with appropriate company departments (legal, finance, etc.)
Ø Prepare and submit regulatory updates with team members
Ø Perform site qualification visits, site initiation visits, site monitoring, site closure visits, inter-acts with the study coordinator and the investigator on a regular basis throughout the trial .
Ø Ensuring the physician’s and research staff adherence to Clinical Trial FDA regulations and the study protocol.
! Ø Performing study device accountability
Ø Verifica! tion of the informed consent form (ICF) for each study subject
Ø Ensuring that adverse experiences are properly documented and reported
Ø Reviewing the case report form (CRF) against the subject's medical record or source documentation for completeness and accuracy
Ø Ensuring the filing and maintenance of the required regulatory documents at investigational sites and at company.
Ø Develop study documents: designing CRFs, randomization scheme, ICFs, IRB applications, and review protocols
Ø Study data processing; collection, entry, verification and summation.
Ø Writing and preparing final study reports, presentations and clinical research Standard Operating Procedures (SOPs).
Ø Assist with protocol development
Ø All applicable regulations/guidelines…
Ø Work with various teams including, but not limited to: regulatory, QA, project managers/scientists
Ø Ensure min! imum SOP annual reviews are documented by individual team members
QUALIFICATIONS:
Prior supervisory responsibility required.
The Sr. CRA, level III, frequently has a healthcare or science background (e.g. nurse, medical technologist, or physical therapist; or Bachelor's, Master’s in a science) and 5-10 years of relevant experience is required. A Sr. CRA, level III, can work either in-house or in the field, therefore the ability for some travel is a requirement. Knowledge of FDA regulatory requirements is required. Familiar with a variety of the field's concepts, practices, and procedures (i.e., clinical research, dermatology, statistical analysis, data management, technical writing). Strong written, communication and computer skills are required. Travel: 15% travel is required
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If you were eligible to this vacancy, please email us your resume, with salary requirements and a resume to FPC.
If you interested on this vacancy just click on the Apply button, you will be redirected to the official website
This vacancy starts available on: Wed, 20 Mar 2013 23:49:25 GMT