Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.
The Temp - Clinical Study Assistant (CSA) supports the clinical study team(s) members in the initiation, maintenance and closeout of clinical projects according to GCP, ICH, CFR and Regeneron SOPs. The Temp - CSA assists the Clinical Study Lead and/or other clinical study personnel with all aspects of study execution.
Essential Functions required for the job. List both technical and managerial requirements if applicable
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
Collates materials for training and investigator 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
May require up to 25% travel
Associates degree and 0-1 year experience
Problem solving/Troubleshooting abilities and resourcefulness
General understanding of the clinical research process and regulations/guidelines
Effective communication and interpersonal skills; ability to build relationships internally and externally, as required
Familiarity with medical terminology
Proficiency with Microsoft Office applications, Excel and PowerPoint
Good time management, ability to prioritize
Effective written and verbal communication skills
Attention to detail and accuracy of work This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.
To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law. Associated topics: biomedical, diet, disease, drug, food scientist, immunology, metabolism, nutrition, transfection, virus
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.