SCYNEXIS, Inc. (NASDAQ: SCYX) is a publicly traded biotechnology company pioneering innovative medicines to help millions of patients worldwide overcome and prevent difficult-to-treat infections that are becoming increasingly drug-resistant. We are developing our lead asset, ibrexafungerp (formerly known as SCY-078), as a broad-spectrum, systemic antifungal for multiple fungal indications in both the community and hospital settings. The New Drug Application (NDA) for BREXAFEMME® (ibrexafungerp tablets) was approved by the U.S. Food and Drug Administration (FDA) on June 1, 2021. For more information, visit www.brexafemme.com. We are also continuing late-stage clinical development of ibrexafungerp for the prevention of recurrent VVC as well as the treatment of life-threatening invasive fungal infections in hospitalized patients.
Ibrexafungerp, the first representative of a novel class of antifungals, is poised to bring significant innovation to the vaginal yeast infection space. There has been no new oral product for over 25 years and healthcare providers are eager to have an alternative to treat their patients. Our passion for the patient is the core foundation of our company and we use our resourceful mindset to drive our efficiency. The company is building its commercial organization and has initiated activities for the H2:2021 launch of Ibrexafungerp in vaginal yeast infections.
We are seeking a highly motivated Clinical Trial Associate, to be based in our Jersey City, NJ offices 2 days a week (flexible schedule for the ideal candidate). We are committed to positively impacting the lives of patients by developing innovative therapies, come join us and make a difference.
The Clinical Trial Associate (CTA) provides administrative and study operational support to the clinical study team(s) responsible for clinical trial execution. The ideal candidate will support internally sourced studies and/or studies outsourced to Clinical Research Organizations (CROs) and other third parties. This position reports to the Senior Clinical Study Manager.
- Organize and deliver analyzable reports and metrics to the clinical study leader.
- Schedule and coordinate meetings, prepare agendas, presentation materials and minutes for clinical study team meetings and other study related meetings.
- Collate data for assessments such as feasibility and site selection.
- Contribute to review of study documents such as informed consent forms, case report forms, study manuals/procedures and facilitate study document reviews.
- Coordinate materials for trainings and investigator meetings.
- Track site activation, enrollment, and monitoring visits to projected plans, and escalate any issues or delays with site activation or deviations from monitoring plan.
- Review monitoring reports as assigned by study manager.
- Directly communicate with CRO & vendors.
- Create and maintain study/project files.
- Collect and query for missing documents from CRO or sites, upload of documents to the eTMF if internal eTMF is used or review/audit CRO eTMF to ensure it is updated per expectations.
- Review and help take actions using Excel tracking sheets as needed (List of investigators, List of active sites, DSURs approvals, Information about ethics committees, tracking of trial approvals expiration dates etc.)
- Maintain site personnel contact list.
- Maintain key study documents on sponsor internal repository.
Requirements and Preferred Skills:
- Associate degree with a minimum of 2+ years of relevant experience in a Life Sciences, pharmaceutical and/or CRO organization.
- Bachelor’s degree preferred.
- Excellent written and verbal communication skills.
- Strong customer service skills and ability to work effectively with vendors and sites.
- Ability to manage multiple projects and timelines simultaneously.
- Ability to prioritize tasks, follow up, and resolve meaningfully.
- Excellent organizational skills and attention to detail are required.
- Strong proofreading, editing, and reviewing skills are needed.
- Must be able to work independently, proactively provide meaningful and timely updates, and participate in meetings and possess problem solving skills.
- Basic knowledge of drug development and FDA GCP/ICH regulatory guidelines.
- Familiarity with DIA TMF Reference Model is preferred.
- Strong skills with Microsoft Excel, Word, Power point required.
- Occasional travel may be required (5-10%) to attend business meetings with vendors or participate in investigator meetings.
- Employment is contingent upon satisfactory results of a pre-employment background check, drug screen and proof of full COVID-19 vaccination.
For more information about SCYNEXIS, please visit https://www.scynexis.com.
An Equal Opportunity EmployerApply Now