This job is no longer active.
View similar jobs.
POST DATE 2/15/2020
END DATE 3/31/2020
JOB DESCRIPTIONESSENTIAL DUTIES AND RESPONSIBILITIES:
* Assist the project team in the planning, setup, monitoring and closeout of a study in the support of reads by tasks such as :
* Understanding of the specific reader requirements of the study and the documentation of appropriate reader candidates for the sponsor s approval decision.
* Support of the prescribed reader contracting needs across multiple areas within ERT.
* Collection and maintenance of all reader compliance documentation and training such as, but not limited to, GCP Training, ER/ES training, and medical licensure.
* Collaborate with the cross functional Imaging team members and authorities to ensure the specification and use of the appropriate equipment (i.e. workstations/laptops) in the read environment is defined and then carried out throughout the study.
* Support the reader equipment use in the execution of the Work Order, ordering equipment and/or traveling for setup if applicable to the Study.
* Assist the project team in the Training and Support tasks to support the read activities such as:
* Reviewing various study documents (Clinical Investigation Protocol, client contracts, evaluation criteria, etc.) to understand and assist the team in the reader management within the study
* Understand and have necessary proficiency in the software used for the expert review
* Facilitate reader training/retraining and insure compliance of training and related requirements and/or documentation
* Support the reader during the expert reviews to include managing turnaround time (TAT) windows, reader compliance and adherence to training, etc.
* 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.
* Ensure compliance with timely training completion/documentation
* Support the Project Team s presentation at Investigator Meetings, site initiation or other meetings as needed.
* Support client meetings with Business Development and/or Operational teams to present Company services and Operational Data flow, as needed and participate in sales initiatives to generate incremental revenu
* Assist with training new members of the Reader Management team
* 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:
* 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 work in a regulated industry, preferably within pharmaceutical, medical device or medical imaging. * Understanding of risk management and the ability to identify potential problems, escalate and assist in resolution as needed.
* 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.
We are an equal opportunity employer and all qualified applicants will 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.