Benefits Offered401K, Dental, Life, Medical, VisionEmployment TypeFull-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
