Clinical Trial Assistant/ Doc Specialist

New Haven, Connecticut /
Research & Development – Research & Development /
Full-time
/ Remote
Clinical Trial Assistant (CTA)
 
Assist the clinical research teams in ensuring the most effective and efficient conduct of clinical research studies by providing administration and project tracking support.
 
This position may be based in New Haven, CT, or remote, based on experience, with visits to the office on a needed basis.

Accountabilities

    • Setup, organize and maintain clinical study documentation (e.g. TMF plan generation and primary oversight/maintenance) including preparation for internal/external audits, final reconciliation and archival.
    • Provide general administrative support to the Clinical Operations Department and assistance to Project Manager(s) and Project Director(s) including support generation/review of study documents (i.e., management plans, manuals, etc
    • Assist the Clinical Operations teams in completion of all required tasks to meet departmental and project goals.
    • Support the Clinical Operations teams with on going conduct of studies and oversight of CROs and third-party vendors as needed.
    • Create and update records for assigned studies in Clinicaltrials.gov
    • May assist in quality control audits of clinical study documentation
    • Attend project team meetings and generate meeting minutes.
    • Assist in the production of slides, overheads, etc. , as needed for project, departmental, sponsor and/or business development presentations.
    • Assist with the coordination of team member tracking.
    • Familiarity with appropriate regulations, relevant SOP’s and CTMS tracking systems.
    • Other duties as assigned.

Required Education, Skills and Experience

    • To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. (US only)
    • Bachelor’s degree preferred but will accept Associates degree (or equivalent) in Life or Social Sciences, Pharmacy or Medicine
    • Minimum of 2 years of experience in a similar position/responsibilities within Clinical Operations, at a pharmaceutical, biotech, health care related academic or medical device industry is preferred
    • At least 1 year working in a remote work setting
    • Good organizational skills, ability to manage multiple tasks and meticulous attention to detail.
    • Good written and verbal communication skills.
    • Team-oriented and proactive and ability to work independently with minimal oversight
    • Good written and spoken English.
    • Computer literacy: e.g. Microsoft Word, Excel, PowerPoint, Outlook.

Education Required

    • Bachelor's and 3 years of experience.

Work Environment

    • Some travel required.


Your Path to Endless Opportunities

If you’re looking to push the envelope and join an innovative company where technology meets drug discovery and development and you’re enthusiastic, creative, with a passion for cutting-edge research, you should join our team! We are looking for highly motivated, passionate employees to help us drive technology solutions for discovering breakthrough treatments for our portfolio of oncology and neuroscience programs, as well as for our partners across major therapeutic areas.

About BioXcel Therapeutics, Inc.

BioXcel Therapeutics, Inc. is a commercial-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology. The Company’s drug re-innovation approach leverages existing approved drugs and/or clinically validated product candidates together with big data and proprietary machine learning algorithms to identify new therapeutic indices. The Company’s commercial product, IGALMI™ (developed as BXCL501) is a proprietary, sublingual film formulation of dexmedetomidine approved by the FDA for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. The safety and effectiveness of IGALMI has not been established beyond 24 hours from the first dose. BXCL501 is also being evaluated for the acute treatment of agitation associated with Alzheimer’s disease, and as an adjunctive treatment for major depressive disorder. The Company is also developing BXCL502 as a potential therapy for chronic agitation in dementia and, under its subsidiary OnkosXcel Therapeutics, BXCL701, an investigational, orally administered, systemic innate immunity activator for the treatment of aggressive forms of prostate cancer and advanced solid tumors that are refractory or treatment naïve to checkpoint inhibitors. For more information, please visit www.bioxceltherapeutics.com.   

EOE/M/F/V/SO
BioXcel Therapeutics is an Equal Opportunity Employer. All qualified candidates will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, gender identity, sexual orientation or protected veteran status.