Clinical Research Associate (FullTime)

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To support existing clinical programs (AMD and DME) and upcoming protocols EOP1008, EOP1009, EOP1010.

Summary

• Supports the authoring of the clinical content of Protocols/Protocol Amendments.
• Authors sample Informed Consent Forms.
• Supports development of Case Report Forms.
• Supports the authoring of the CRF Review Manual.
• Assists in the development and execution of investigator contracts.
• Prepares study start-up documents including investigator study files, enrollment logs, etc.
• Assists in planning and preparing Investigator Meetings.
• Assists in the development of patient recruitment strategy.
• Clinical Study Execution: Assists in providing clinical-related progress of project schedule and budget to project management.
• Collects and reviews regulatory documents.
• Develops ability to independently conduct pre-study, initiation, monitoring, and closeout visits.
• Manages day-to-day interactions with study sites.
• Completes site visit reports, site correspondence, telephone logs, and other relevant documents.
• Reviews, maintains, and archives study administrative files.
• Manages clinical supplies at investigative sites.
• Prepares and presents with guidance at Investigator Meetings training sessions and internal meetings.
• Reports Serious Adverse Events and reconciles database.
• Participates in data management process including the collection and cleaning of data, and the identification and resolution of data queries
• Implements, tracks, and reports patient recruitment and retention at investigational sites.
• Proactively identifies study-related issues and provides recommendations for resolution.
• Clinical Study Reporting: Completes the final reconciliation of clinical drug supply, adverse events database, and study file archives.
• Supports the authoring of clinical portions of Clinical Study Reports and annual reports.
• Assists in preparation of NDAs.
• Demonstrates intermediate knowledge of the clinical study process, GCP/ICII guidelines and SOPs
• Develops knowledge of therapeutic area through experience and review of scientific literature
• Demonstrates analytical thinking, concern for standards, concern for impact, good team skills (including cooperation) willingness to learn from others, sharing of relevant information, adaptability, self-control, tenacity, and conflict-resolution skills
• Demonstrates computer proficiency and has the ability to develop advanced computer skills to increase efficiency in day-to-day tasks
• Excellent organization and time management skills, detailed-oriented, ability to multitask in a high-volume environment
• Develops ability to prepare and present at internal and external meetings
• Develops ability to plan, coordinate, and facilitate internal and external meetings
• Demonstrates professionalism and mutual respect.

Qualifications

• Bachelor’s degree in biological science or healthcare-related field or licensed registered nurse.
• Three to five years of relevant experience in industry (strongly preferred), or healthcare-related field, or equivalent overall experience in combination with exceptional performance.
• Good oral and written communication skills.
• Detail-oriented.
• Demonstrated ability to work in a team environment, as well as independently
  Position availible in NYC and Cedar Knolls NJ