Clinical Study Assistant (CSA) provides technical and administrative support to the clinical study team(s) responsible for clinical trial execution.
A typical day might include the following:
This role might be for you if:
- Participates in Clinical Study team meetings for one or more clinical studies
- Assists in the writing, collection, distribution and filing of meeting agenda and meeting minutes
- Supports the scheduling and coordination of project team meetings and minutes
- Assists with requesting, collecting, and reviewing site regulatory documents
- Tracks site study start up status and activities using established study tools
- Support maintenance and reconciliation (QC) of essential study documents and electronic Trial Master File (eTMF) according to TMF plan.
- 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 study specialist or manager for: study binders (regulatory, pharmacy, laboratory), study reference manuals, CRA training and Investigator Meeting materials, and study data collection tools
- Maintains team SharePoint and/or shared drive sites as needed
- Assists or drives the submission process for internal review committees (e.g., RCRC) and may attend review meetings on behalf of the study team
- Requests Clinical Disclosure Agreements (CDA) and consulting agreements
- Assists with reviewing monitoring visit reports and providing feedback to the CSL
- Uses judgment to escalate issues to the appropriate team members for consideration and resolution
- Applies knowledge of company policies and standard practices to resolve problems
- Works with other internal departments to provide and receive required information required for achievement of Clinical Research assignments, goals and objectives
- Schedules and coordinates meetings
- Updates investigator/site status for the trial
- Ensures scheduled reports are received (i.e. FDA Form 1572 reportable changes, financial disclosure form status)
- Tracks and monitors study close out activities – including study close-out documents (FDA Form 1572s, Investigational Product reconciliation, Financial Disclosures, etc.) and Clinical Research Associate (CRA) close-out visits
- You enjoy problem solving and are resourceful
- You have effective communication and interpersonal skills, with an ability to build relationships internally and externally
- You are good time with management and can prioritize
- You have a strong attention to detail with accuracy of work
To be considered for this opportunity you must possess a Bachelor’s degree and a 1+ years’ industry related work experience. We require someone who has a general understanding of the clinical research process and regulations/guidelines, as well as a familiarity with medical terminology.
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 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.
Development Operations - #GDDOPMJobs