Sub Investigator

Responsibilities

• Serve as leader of a study team to execute clinical trials
• Mentor and train staff in the conduct of clinical trials, protocol requirements, communication, and trial management skills
• Create training strategies and mitigation plans
• Conduct and manage clinical trials in accordance with the study protocol, GCP, ICH Guidelines and Velocity’s SOPs
• Implement and coordinate assigned clinical trials including start up, vendor management, subject recruitment, source development review, scheduling subjects, protocol training, collection of regulatory documents, conducting visits, ensuring data is entered in a timely manner and all queries are resolved, managing and reporting adverse events, serious adverse events, and deviations, implementing new protocol amendments, providing all close out reports.
• Apply project management concepts to manage risk and improve quality in the conduct of a clinical research study
• Communicate effectively and professionally with coworkers, leadership, study subjects, sponsors, CROs, and vendors
• Ensure good documentation practices are applied by team members when collecting and correcting data, transferring data to sponsor/CRO data capture systems and resolving queries
• Ensure confidentiality of patient protected health information, sponsor confidential information and Velocity confidential information is maintained by all team members
• Develop, coordinate, and implement research and administrative strategies to successfully manage assigned protocols
• Evaluate potential subjects for participation in clinical trials including phone and in person pre-screens
• Create and execute recruitment strategies in conjunction with patient recruitment staff
• Incorporate key timelines, endpoints, required vendors, and patient population when planning for each assigned protocol
• Incorporate understanding of how decisions affect the bottom-line including links between operations and company’s financial performance and how it is essential to create value of all stakeholders of the organization when planning for each assigned protocol
• Incorporate understanding of product development lifecycle and significance of protocol design including critical data points when planning for each assigned protocol
• Develop Quality Control strategies for team member projects
• Perform clinical duties (e.g. Drug preparation and administration, fibroscan, phlebotomy, ECG, lab processing) within scope
• Promote respect for cultural diversity and conventions with all individuals

Qualifications

• Must undertake all training and certification required by sponsors and CRO’s to carry out clinical trials within specified timelines
• Safe handling of data and records regarding privacy and confidentiality, per HIPAA requirements
• Practices professionalism and integrity in all actions – Demonstrated ability to foster concepts of teamwork, cooperation, self-control, and flexibility to get the work done
• Ability to communicate effectively in English (both verbal and written)
• Up to 10% travel, as needed, for project team meetings, client presentations and other professional meetings/conferences as needed

Skills/Abilities

• Must undertake all training and certification required by sponsors and CRO’s to carry out clinical trials within specified timelines
• Safe handling of data and records regarding privacy and confidentiality, per HIPAA requirements
• Practices professionalism and integrity in all actions – Demonstrated ability to foster concepts of teamwork, cooperation, self-control, and flexibility to get the work done
• Ability to communicate effectively in English (both verbal and written)
• Up to 10% travel, as needed, for project team meetings, client presentations and other professional meetings/conferences as needed

Benefits

• Medical, dental and vision insurance
• Paid time off and company holidays
• 401(k) retirement plan with company-match
• An annual incentive program