Clinical Trial Associate (CTA)

Location
New York City Metropolitan Area, New York, United States
Posted
Nov 24, 2020
Ref
2300366665
Hotbed
Pharm Country
Required Education
Bachelors Degree
Position Type
Full time
OVID Therapeutics

Ovid Therapeutics (NASDAQ: OVID) is a New York-based biopharmaceutical company using its BoldMedicine™ approach to develop medicines that transform the lives of patients with rare neurological disorders. Ovid has a broad pipeline of potential first-in-class medicines. The company's lead investigational medicine, OV101, is currently in development for the treatment of Angelman syndrome and Fragile X syndrome. Ovid is also developing OV935/TAK-935 in collaboration with Takeda Pharmaceutical Company Limited for the treatment of rare developmental and epileptic encephalopathies (DEE).

POSITION

The Clinical Trials Associate will collaborate directly with the clinical site staff to ensure management and alignment on Ovid business processes and execution of study timelines. He/She will manage multiple site level deliverables during start-up, maintenance, and closure both within Ovid and external business partners and vendors. The CTA will identify opportunities to interact, builds and strengthens professional and collaborative relationships with all internal and external stakeholders (e.g., site and institutional personnel, Thought Leaders, internal colleagues, etc.).

RESPONSIBILITIES

  • Contribute to and embrace Ovid Therapeutics mission and values
  • Motivate/influence stakeholders to meet study objectives, including enrollment and retention goals
  • Conduct initiation visits in collaboration with Clinical Site Managers
  • Documents visit and communicate findings
  • Manage and make decisions on the development and execution of study related binders at study start-up
  • Responsible for site level source documentation within the Clinical Trial Master File to ensure accuracy and completeness of the trial master file in preparation for audit and inspection
  • Execute all appropriate business processes to ensure Clinical Trial Package completion for drug shipment in achieved
  • Resolves study site problems/issues as they occur
  • Initiate, recommend, document and communicate corrective actions as needed and follows up to ensure corrective actions are implemented
  • Support the Regulatory Compliance audit process as needed
  • He/She will drive the collection and review of site regulatory documentation directly from US sites in accordance to SOPs, ICH/GCP and regulatory guidelines
  • Use multiple technologies to maintain open and frequent communication with all stakeholders
  • Exhibit flexibility and adaptability when facing change


REQUIREMENTS:

  • BA/BS degree in nursing, life science or healthcare related field
  • 2 + years minimum experience Clinical Trial Associate
  • Knowledge of ICH/GCP Guidelines and local regulatory guidelines or regulations preferred
  • Experience in the use of industry Clinical Trial Management Systems and Clinical Trial Master File Systems or equivalent
  • Current knowledge and understanding of appropriate therapeutic indications and Health Authority (HA) regulations as they relate to the conduct of clinical trial
  • Demonstrates the initiative and skills to remain current on recent advances in medicine and medical technology


PREFERRED QUALIFICATIONS:

  • Additional complex software application related to clinical trial research, electronic data capture or patient diaries, interactive voice response


*Equal Opportunity Employer/Veterans/Individuals w/Disabilities

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