Senior / Clinical Research Associate (CRA)

2 months ago

Bedminster, United States INTRA-CELLULAR THERAPIES INC Full time
Job DescriptionJob Description

Benefits Offered

401K, Dental, Life, Medical, Vision

Employment Type

Full-Time

“We deliver innovative treatments to improve the lives of individuals suffering from neuropsychiatric, neurologic and other disorders”

Intra-Cellular Therapies Inc. is a publicly traded biopharmaceutical company headquartered in New York City. Founded on Nobel-prize winning research, we launched our first commercial product in CNS in 2020 and received approval for an expanded indication in 2021. Currently celebrating our 22nd anniversary, we have a strong pipeline with projects in preclinical development stage through Phase III. We celebrate science, welcome curiosity, expect collaboration and demand integrity and respect in all we do, create and deliver.


The in-house Clinical Research Associate / Senior Clinical Research Associate (CRA) is a key contributor to early phase/clinical pharmacology studies. The CRA is responsible for the quality and compliance of site monitoring activities through oversight of the Contract Research Organizations (CROs) or direct management of insourced site monitoring activities. The CRA collaborates with CROs and sites to identify and address issues and secure compliance. The CRA is accountable for developing and reviewing several study documents. The position requires close collaboration with individuals within the Clinical Pharmacology department and across other departments.

Responsibilities

  • Act as primary contact for external CRAs
  • Mange clinical site contacts and provide documentation
  • Manage access to vendor portals
  • Review Clinical Monitoring Plans and Monitoring Reports
  • Conduct site feasibility and site evaluations
  • Manage RFPs for clinical sites
  • Review eCRFs during database build
  • Review source document templates from clinical sites
  • Train external CRAs on study protocol specifics & maintain training documentation
  • Contact sites for specific requests (enrollment updates, action item resolution or missing documentation) or other sponsor specific CRA tasks
  • Collect study documents from clinical sites
  • Facilitate or schedule site trainings as required per study protocol
  • Assist with recruitment activities (reviewing phone scripts, questionnaires, study site material, and other tools)
  • Manage Protocol Deviations
  • Participate in QA audits of sites
  • Assist in collecting and filing of regulatory documents for TMF
  • Regularly attend study team meetings and departmental meetings
  • May request cost estimates for clinical studies, manage purchase orders and invoices, and provide timely resolution to financial inquiries; May develop Informed Consent Forms
  • Complete all company and job-related training as assigned within the required timelines.
  • Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Requirements

  • Bachelors Degree with 4+ years of experience in related role (site management, CRA or study coordinator, CRA) including Phase 1 experience
  • Strong understanding of ICH/GCP, applicable standards, and FDA regulations for clinical trials
  • Proven ability to be careful, thorough, and detail-oriented
  • Strong organizational skills and the ability to multi-task and work effectively in a fast-paced cross-functional team environment
  • Strong analytical, negotiation, meeting management, and leadership skills
  • Ability to problem-solve unstructured or ambiguous challenges
  • Strong command of English, both written and verbal
  • Excellent communication and interpersonal skills with customer service orientation
  • Strong skills with MS Office Suite, particularly Word, Excel, and PowerPoint
  • Experience working with Veeva Vault
  • Willingness to travel up to 20%, as needed
  • Must be able to perform all essential functions of the position, with or without reasonable accommodation.

Intra-Cellular Therapies is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, protected veteran status, disability or any other legally protected status.

#ITCI

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