The Clinical Study Specialist (CSS) provides technical and administrative support to the clinical study team(s) responsible for clinical trial execution. The CSS may be assigned to support the execution of one or more studies across a program. The CSS receives assignments from the Clinical Study Lead or Clinical Study Associate Manager. The CSS will support internally sourced studies and studies out-sourced to Clinical Research Organizations (CROs).
A typical day in this role looks like:
- Organizes and delivers analyzable reports and metrics to the clinical study lead
- Schedules and coordinates meetings, prepares agendas, presentation materials and minutes for clinical study team meetings and other study related 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
- Compiles study manuals including but not limited to 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, enrollment 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 clinical study lead 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
- Contributes to line listings review for Blind Data Review Meeting (BDRM)
- May manage or contribute to oversight of Third-Party Vendors (TPV)
- Tracks and monitors close out activities – study close-out documents (1572s, Investigational Product reconciliation, Financial Disclosures, etc.) and CRA close-out visits
- Participates in Standard Operating Procedures (SOPs) revisions or departmental initiatives
- Proactively recommends process improvement initiatives for the department
This role may be for you if you have:
- 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
In order to be considered for this role, a minimum of a Bachelor's degree of 2+ years’ industry related work experience in a clinical setting.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.
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. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
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Regeneron Dublin, Dublin, IRL Office
One Warrington Place, Dublin, Dublin, Ireland, DO2 HH27
