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This is a contract role dedicated to a specific sponsor. The initial contract will last through December 2022 but has the potential to extend beyond that date.
ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
Under the direction of the Associate Manager, Clinical Research, is responsible for coordinating a wide variety of project and department tasks, as listed below.
Project Responsibilities, as assigned
- Using Medidata CTMS, and other data tools, create and maintain various clinical operations tracking systems to assist Clinical Trial Managers (CTMs) in the management of both clinical trial activities and assigned CRAs.
- Assists with preparations for internal audits and track progress as requested.
- Takes and distributes meeting minutes for internal and external teleconferences.
- Coordinates other clinical trial operations tasks/activities as requested and budgeted.
- Clinical document routing per procedures.
- Format Annual and Final Progress Reports, assist with generation of certain aspects of report.
- Schedules and arranges Teams presentations as requested.
- Assist with new hire onboarding; track progress towards completion; create and maintain completion log; schedule and manage onboarding meetings.
- Assist with tracking training progress and assign curriculums in the Stryker Learning Management System (SLMS)
- Assist with the creation of automated training within SLMS to use for new hires as well as new Study Coordinators
Department Responsibilities, as assigned
- Provides Clinical Research Department metrics on a daily, weekly, monthly, quarterly, and annual basis as requested. Work with Programming to build reports and ensure appropriate and accurate metrics are run as requested.
- In conjunction with management and SOP process owner, support development, documentation, and updates to internal processes, procedures, SOPs, working practices, and related quality documents as related to the job function. May prepare process and flow diagrams with Visio and/or similar software. .
- Serves as a Clinical Research Department “Go To” person for department staff questions regarding Microsoft programs such as Word, Excel, Power Point and Project.
- Trains/ mentors new employees in the implementation of tasks and responsibilities within their job description as requested. Maintain new hire checklist, and manage their progress towards completion.
- Manages department new hire integration (CSMs, CRAs, CSAs) as assigned, including delivery of the initial Department Welcome e-mail, , directing new hires to Training and Orientation, entering tickets for equipment and systems access and acting as a point person for questions during their employment with the Department.
- Coordinates the administrative and contractual activities associated with any department meeting. Attends department meetings as assigned/requested.
- Assists team in generation, editing and proof-reading of Annual and Final Study Reports. Assists with generation of any necessary communications to sites, for example newsletters.
- Maintains monitoring calendar and ensures it is regularly updated by applicable team members. Communicate changes in assignments, and address any CRA questions.
- Manages the organization and currency of CR Department information pertaining to study assignments and progress, project budget tracking, department initiatives, etc., as assigned.
- Liase with Associate Manager, Clinical Research and the Training Department to ensure SLMS compliance for all Clinical Research Department staff members, as assigned.
- Assists Associate Manager, Clinical Research with preparation of presentations as requested.
- Performs other duties as assigned.
KNOWLEDGE, SKILLS AND ABILITIES:
- Working knowledge of, and aptitude for, activities related to clinical research, both domestic and international.
- Familiarity with or ability to become familiar with clinical research documents.
- Familiarity with, or ability to become familiar with, principles of Good Clinical Practice, ICH and ISO standards.
- Familiarity with, or ability to become familiar with, 21CFR11 and EDC systems.
- Good interpersonal skills with the ability to communicate effectively, both orally and in writing, with all levels of staff, and with the public.
- Ability to be detail oriented with background adequate to understand clinical trial operational issues.
- Ability to work on multiple tasks simultaneously and prioritize work accordingly.
- Computer literate to an advanced level with Microsoft programs such as Word, Excel, Power Point, Project etc. such that they are the “Go To” person for Clinical staff software questions.
CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:
- Very limited physical effort required to perform normal job duties
MINIMUM RECRUITMENT STANDARDS:
- School diploma/certificate or educational equivalent; or equivalent combination of education, training and experience; BS/BA (or equivalent) preferred.
- Minimum of six months experience in a clinical research setting is preferred
- Excellent analytical and verbal/written communication skills.
- Effective time management and organizational skills.
- Attention to detail and accuracy in work.
- Demonstrated ability to prioritize and work efficiently.
- Strong customer service orientation.
- High degree of self motivation.
- High computer literacy with Microsoft Word, Excel, Power Point, Publisher, etc, is required. Demonstrated ability to work with various CTMS and/or EDC systems.
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com
We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe
As the COVID-19 virus continues to evolve, IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status