Clinical Study Specialist
- Employer
- Regeneron Pharmaceuticals, Inc.
- Location
- Basking Ridge, New Jersey
- Start date
- Sep 24, 2021
View more
- Discipline
- Clinical, Clinical Medicine, Clinical Research
- Required Education
- High School or equivalent
- Position Type
- Full time
- Hotbed
- Pharm Country, Best Places to Work
Job Details
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 CSS will support internally sourced studies and studies outsourced 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 directed 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 department
You have strong attention to detail to track information and deliver on assigned study activities
You have good communication and interpersonal skills, with an ability to build relationships internally and externally
You can be resourceful and demonstrate problem solving skills
You demonstrate the ability to proactively assess information and investigate the impact on clinical trials
You are interested in acquiring further knowledge of clinical trial management activities
You are proactive and self-disciplined, you can meet deadlines, and effectively use your time and prioritize
To be considered for this opportunity you must possess 2+ years’ industry related work experience. A High School Diploma is required. A Bachelor’s degree is preferred. An advanced degree in a related field with a minimum of one (1) to two (2) years of relevant work experience may be considered. You should have a familiarity with medical terms and clinical drug development, and an awareness of ICH/GCP.
Does 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.
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Company
Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.
Stock Symbol: REGN
Stock Exchange: NASDAQ
- Website
- https://www.regeneron.com/
- Phone
- 914-847-7000
- Location
-
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States
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