Virscio is seeking a Study Coordinator to support translation of preclinical research protocols to procedure and data collection execution and documentation plans. Administration of electronic data management systems (EDMS) critical to study execution and associated scheduling, responsibility allocation, and resource management systems will be critical job functions along with serving as system owner and administrator for EDMS platforms dedicated to these functions. Additional responsibilities will include execution and update of relevant Standard Operating Procedures and associated staff training.

The Study Coordinator reports directly to the Director of Research Operations. The ability to communicate effectively with management, Study Directors, and research technicians is key within a cross-functional, flexible, and collaborative research team.

Note:  Virscio requires all employees to be fully vaccinated for COVID to ensure personal, team, and animal research safety purposes.  

Responsibilities:

·       System owner for Pristima and associated electronic data management systems

·       Lead or support migration of contracted study protocols into Pristima environment and engage Study Directors, management and research technicians on scope and scheduling 

·       Engage with management and Study Directors to define and update study scheduling within Pristima

·       Develop and maintain Pristima protocol and data report master templates

·       Support and lead development of expanded data entry (measurement) forms to support broader study activities

·       Perform periodic review of all applicable standard operating procedures (SOPs) to ensure accuracy and confirm procedures are being performed according to SOPs

·       Participate in SOP writing, reviews, and revisions, as needed

·       Develop training content and lead training presentations regarding use of relevant EDMS platforms

·       Communicate effectively with all key stakeholders including Study Directors, technicians and management

·       Lead creation and testing of new data entry (measurement) forms prior to implementation and ensure associated training, SOPs and change control procedures are followed

·       Complete training requirements as assigned and maintain appropriate training documentation

·       Maintain compliance with all policies and procedures

·       Ensure compliance with GLPs, AAALAC, OLAW and other applicable regulations

·       Perform quality checks on all Pristima content (e.g., protocols, amendments, data review, reports, tables, etc.)

·       Engage with and support Systems Validation team to ensure validation, periodic review and change control procedures are performed in accordance with relevant SOPs and 21 CFR Part 11 compliance

·       Perform other duties as assigned

Education/Qualifications:

·       Bachelor's degree in life sciences and/or computer science or other directly related field or degree with comparable coursework

·       Minimum of 1 year in a relevant pharmaceutical setting

·       Possess strong skills for editing the format, style and language of draft protocols, spreadsheets and reports

·       Experience using Microsoft Office (Word, Excel, Outlook), Pristima experience a significant plus

·       Excellent written and verbal communication skills

·       An attitude for quality, an eye for detail and the ability to read and follow written instructions

·       Ability to interact with scientific staff at all levels

·       Ability to work in St. Kitts, West Indies, or New Haven, CT; remote work possible with exceptional credentials

·       Ability to work within 8:00 a.m. -17:00 p.m. eastern time zone

·      Virscio requires all employees to be fully vaccinated for COVID to ensure personal, team, and animal research safety.