Temp-Clinical Study Specialist
Company: Regeneron Pharmaceuticals, Inc.
Location: Basking Ridge
Posted on: May 16, 2022
Job Description:
The Temp - Clinical Study Specialist (CSS), provides technical
and administrative support to the clinical study team(s)
responsible for clinical trial execution. The individual may be
assigned to support the execution of one or more studies across a
program. The Temp - CSS will support internally sourced studies and
studies out-sourced to Clinical Research Organizations (CROs).A
typical day might include the following:
- Organizes and delivers analyzable reports and metrics to the
Clinical Study Lead (CSL)
- Schedules and coordinates meetings, prepares agendas,
presentation materials and minutes for study team meetings
- Collates data for assessments such as feasibility and site
selection and reviews site usability database
- Contributes to review of study documents such as informed
consent forms, case report forms and facilitates study document
reviews per company standard operating procedures (SOPs)
- Compiles study manuals including study reference binders and
manuals and maintains versioning of study reference materials
(e.g., regulatory, pharmacy, and laboratory binders
- Collates materials for training and investigator meetings
- Tracks site activation, enrolment and monitoring visits to
projected plans, and escalate any issues or delays with site
activation or deviations from monitoring plan
- Monitors and updates investigator/site status for the trial,
and supports with clinical trial registry postings
- Performs scheduled reconciliations of study Trial Master File
(TMF) with CSL guidance
- Ensures scheduled reports are received (i.e. 1572 reportable
changes, financial disclosure form)
- Manages and maintains team SharePoint and/or shared drive
sites, as needed
- Communication with sites as advised and maintains site contact
information
- Tracks and monitors close out activities - study close-out
documents (1572s, Investigational Product reconciliation, Financial
Disclosures, etc.) and CRA close-out visits
- Participates in SOPs revisions or departmental initiatives
- Proactively recommends process improvement initiatives for the
departmentThis role might be for you if:You have strong attention
to detail to track information and deliver on assigned study
activitiesYou have good communication and interpersonal skills,
with an ability to build relationships internally and externallyYou
can be resourceful and demonstrate problem solving skillsYou
demonstrate the ability to proactively assess information and
investigate the impact on clinical trialsYou are interested in
acquiring further knowledge of clinical trial management
activitiesYou are proactive and self-disciplined, you can meet
deadlines, and effectively use your time and prioritizeTo be
considered for this opportunity you must possess:
- Bachelor's degree with 2+ years of relevant experience. In lieu
of a Bachelor's Degree 5+ years of relevant experience
- Attention to details for the ability to track information and
deliver on assigned study activities
- Good communication and interpersonal skills; ability to build
relationships internally and externally
- Ability to be resourceful and to demonstrate problem solving
skills
- Demonstrate the ability to proactively assess information and
investigate impact on clinical trials
- Ability to acquire working knowledge in trial management
systems and MS applications including (but not limited to) Project,
PowerPoint, Word, Excel, IVRS/IWRS, EDC, TMF
- Proactive and self-disciplined, ability to meet deadlines,
effective use of time, and prioritization
- Basic familiarity with medical terms and clinical drug
development
- Awareness of ICH/GCPDoes this sound like you? Apply now to take
your first steps toward living the Regeneron Way! We have an
inclusive and diverse culture that provides amazing benefits
including health and wellness programs, fitness centers and stock
for employees at all levels!Regeneron is an equal opportunity
employer and all qualified applicants will receive consideration
for employment without regard to race, color, religion or belief
(or lack thereof), sex, nationality, national or ethnic origin,
civil status, age, citizenship status, membership of the Traveler
community, sexual orientation, disability, genetic information,
familial status, marital or registered civil partnership status,
pregnancy or maternity status, gender identity, gender
reassignment, military or veteran status, or any other protected
characteristic in accordance with applicable laws and regulations.
We will ensure that individuals with disabilities are provided
reasonable accommodations to participate in the job application
process. Please contact us to discuss any accommodations you think
you may need.
Keywords: Regeneron Pharmaceuticals, Inc., Newark , Temp-Clinical Study Specialist, Healthcare , Basking Ridge, New Jersey
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