Sr./Clinical Trial Associate
Transcend Therapeutics
New York, NY, USA
Posted on Saturday, July 8, 2023
About Transcend
Transcend Therapeutics is a clinical-stage, neuroscience-focused company developing next-generation psychoactive medicines for neuropsychiatric disease. Transcend develops medicines that are accessible to a larger percentage of patients in need, specifically the tens of millions of patients who already take psychotropic medication. We have real-world data showing that our lead product provided significant benefit to >85% of patients with PTSD and depression. We have already advanced our lead compound into an approved Phase II study in PTSD, with plans to expand into depression and other indications.
Transcend’s leadership team includes the first scientist to receive federal funding for clinical psychedelic research in over 50 years and drug development executives with pivotal contributions to 13 FDA approvals, including the most recently approved drug for depression, and $7B dollars in M&A and public company value. Transcend has raised approximately $42M to date, and has been featured in the Wall Street Journal, Forbes, and Politico.
As a Public Benefit Corporation, we have pledged 10% of founding shares toward nonprofits focused on scientific research and patient access.
About the Role
The Sr. Clinical Trial Associate (CTA) is a founding member of the Clinical team, with responsibilities for supporting the operational aspects of one or more clinical trials. The CTA will support the clinical trial manager, CRAs, and the investigational sites. The CTA will be a key team member in supporting the overall growth of the clinical team.
This position is highly visible in a small, growing organization which may provide for the opportunity for rapid advancement. A successful CTA is forward thinking, takes initiative, and detail-oriented.
Key responsibilities will include:
- Assist clinical team during all phases of a clinical study (feasibility, start-up, maintenance, and close-out)
- Support field-based clinical study monitors
- Participate in vendor and study team meetings, including drafting meeting minutes, as needed
- Collect and review essential regulatory documents
- Submission and tracking of documents to central IRB
- Distribute materials to study sites, as directed
- Create and maintain study trackers (e.g., contact lists, study status trackers, enrollment)
- Review and maintain documents in the Trial Master File (TMF)
- Support internal data review, as needed
- Participate in creation, review, and revision of clinical SOPs
- Assist in preparation and coordination of Investigator Meetings, as needed
- Additional responsibilities as required
This is a great opportunity to step into a high-impact, high-visibility role on the early team of Transcend Therapeutics. We offer competitive cash and equity compensation; medical, dental, and vision insurance; 401k; unlimited vacation and sick time; and more.
The salary range for this role is $70,000 to $100,000, plus equity and benefits.
Experience Requirements
- Bachelor’s degree, preferably in a life science
- At least 1+ years of clinical research experience
- Experience in conducting studies in psychiatry-related indications is preferred
- Proficient knowledge of GCP/ICH, drug development process, clinical operations
Key Competency Requirements
- Excellent verbal, written, communication and interpersonal skills
- Detail-oriented, with a desire to ‘get in the weeds’ and understand the nuances
- Flexible, able to pivot when needed
- Able to effectively communicate and collaborate across functions and job levels
- Internally motivated, with a passion for mental health
- Consistently takes initiative
Travel Required
- Domestic and international travel may be required (approximately 5%)
We are committed to building a diverse, inclusive, and talented team, free from discrimination. If you're excited about our mission but don't meet 100% of the qualifications above, we encourage you to apply.
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