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POST DATE 2/15/2020
END DATE 3/31/2020
JOB DESCRIPTIONESSENTIAL DUTIES AND RESPONSIBILITIES:
* Assist the project team in the planning and setup of a study in the support of the Imaging site which may include:
* Entering the sites, to the imaging platform being used for the clinical trial.
* Entering sites into the company s ERP (Enterprise Resource Planning) System or other internal systems as designated.
* Sending the site survey questionnaires to the sites for site qualifications
* Track training progress and Issue qualification certificates upon successful completion.
* Assist in the preparation of study start - up site documents (i.e. site procedure manuals, analysis plans, etc.), send to the sites when appropriately executed.
* Assist with recommendation of equipment required to the site (i.e. Video cameras, EEG equipment, photography supplies (i.e. cameras, stands,) and ensures shipment of any equipment that will be used during the clinical trial, it applicable to study
* Assist with the shipment of any equipment that will be used during the clinical trial, if applicable to study.
* Assist the project team in the site training process in areas such as:
* Schedule logistical and technical trainings with site personnel as defined in the statement of work, (i.e. via WebEx, Investigator Meeting, or face to face).
* Track training progress, alert Site Project Managers of status to ensure compliance and issue site training certifications upon successful completion.
* Support site compliance activities by working with the project team (i.e. QC) in areas such as:
* Monitoring site query resolution and follow up.
* Scheduling of conducting site as needed.
* Distribute 100% of site reports as needed.
* Provide general support to sites directly or by working with the project team and/or customer care in areas such as:
* Distribution of trial support materials (i.e. image acquisition standard supplies).
* System support (i.e. password resets, upload assistance).
Support study timelines and Project Management team in the deliverables within each study, to include reporting components to support:
* Budget reviews
* Revenue forecasting
* Scope changes
* Invoice reconciliation
OTHER DUTIES AND RESPONSIBILITIES:
* Follow Guidelines consistent with Good Clinical Practices as well as the internal Standard Operating Procedures (SOP)s and Standard Work Instructions (SWI)s.
* Attend Sponsor calls as deemed necessary in the support of the larger project team.
* Ability to establish priorities, work independently, and proceed with projects with minimal supervision.
* Ability to deliver high quality and high productivity.
* Other related assignments, projects and tasks as assigned.
The duties and responsibilities listed in this job description represent the major responsibilities of the position. Other duties and responsibilities may be assigned, as required. ERT reserves the right to amend or change this job description to meet the needs of ERT. This job description and any attachments do not constitute or represent a contract.
QUALIFICATIONS AND SKILLS NEEDED:
(Key wording should include if degree is needed, any travel requirements, special qualifications needed, skills, etc.)
* One to three years of related project involvement with additional experience preferred in the workflows within one or more of: clinical trial management, healthcare management/operations, pre-clinical research, radiologic or related science.
* Degree in business, radiologic/related science or equivalent. Familiarity or coursework desired in areas where degree is not held and additionally, data management and imaging. Experience in lieu of degree will be considered.
* Must be computer literate with application knowledge of Microsoft Word, Excel, PowerPoint, database querying, e-mail and electronic calendar.
* Must have the ability to travel.
* Detail oriented and demonstrated responsiveness to inquiries and requests.
* Understanding of risk management and the ability to identify potential problems, escalate and assist in resolution as needed.
* Understanding of work in a regulated industry, preferably within pharmaceutical, medical device or medical imaging.
* Excellent communication and organizational skills with a strong ability to collaborate in English with teams of research scientists, bioinformaticians, software developers, and external collaborators. Will have frequent interaction with clients, sites, management and staff.
ERT is an equal opportunity employer and all qualified applicants receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law.