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

This role might be for you if:

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

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/GCP

Development Operations - #GDDOPMJobs #heme

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 comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible 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 parental 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.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

$88,500.00 - $144,500.00