The CTM intern provides administrative support to the clinical study team (CST) responsible for clinical trial execution. The CTM intern may be assigned to support the execution of one or more studies across a program. The CTM intern receives assignments from the Senior Director CTM, Clinical Study Lead or Clinical Study Associate Manager. The CTM intern could support internally sourced studies and studies out-sourced to Clinical Research Organizations (CROs).
Serve as the administrative support for the Clinical study team (CST) working in compliance with SOPs, FDA regulations, GCP and ICH guidelines
Attend regular CST meetings for one or more studies. Support the Clinical Study Specialist (CSS) to schedule and coordinate meetings, prepares agendas, presentation materials and minutes for clinical study team meetings and other study related meetings
Supports events management and organization (e.g. Investigator meetings, team meetings)
Distributes materials to study sites, as directed
Assists with requesting, collecting, and reviewing site regulatory documents
Tracks site study start up status and activities using established study tools
Review, maintain, and reconcile (QC) essential study documents and electronic Trial Master File (eTMF) according to TMF plan
Collaborate with the eTMF lead to ensure completeness, quality and timeliness is followed by the study team
Supports and participates in tracking organization and maintenance of study reporting tools such as monitoring visit schedules
Collates and assembles study documents under guidance of the CSS or Clinical Study Lead (CSL) for study binders (regulatory, pharmacy, laboratory), study reference manuals, CRA training and Investigator Meeting materials, and study data collection tools
Supports the CSS to maintain team SharePoint and/or shared drive sites, as needed
May also support other projects within CTM as guided by the Senior Director CTM
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.
