Mgr Clinical Research

CTI Clinical Trial and Consulting Services

JOB PURPOSE / SUMMARY

Responsible for staffing and managing Employee, Consultant or Freelance Clinical Research Associates (CRAs), In-House Clinical Research Associates (, Clinical Project Assistants (CPAs) and Clinical Projects Coordinators (CPCs) and ensuring adherence to and implementation of CTI policies. Manage quality and consistency of CRA services across multiple projects according to all applicable regulatory guidelines, Good Clinical Practices (GCPs) and Standard Operating Procedures (SOPs).

ESSENTIAL FUNCTIONS

• Responsible for the ongoing job specific training and mentoring of the subordinate CRAs and CPAs/CPCs s in accordance with Department goals and mission. Supervision of the work of subordinate CRAs and CPAs/CPCs.
• First line of communication and escalation for the subordinate CRAs and CPAs/CPCs, including for HR and administrative issues.
• Issue, Task and Time management of the subordinate CRAs and CPAs/CPCs.
• Assuring compliance of subordinate CRAs and CPAs/CPCs to the applicable procedures, guidelines, timelines, and deliverables.
• Regular assessments and appraisals of CRAs and CPAs/CPCs and their level of competence.
• Quality Control - performs co-monitoring visits and reviews visit reports for the subordinate CRAs when needed.
• Regular reporting to Director CLO Dept. and participation in meetings with other CRMs, PMs. Participate in the process of development and update of department-specific company SOPs and Wis when required
• Execute any activities in compliance with applicable SOPs, instructions and principles.
• Provide enough/trained resources for all projects to ensure smooth conduction of study specific activities.
• Collaborate with Director of clinical operations , on planning, assigning, and directing billable work assignments to CRAs, to ensure projects are properly resourced and study timelines are met.
• Assist in collecting preliminary and follow-up information from clients, with the purpose of identifying and evaluating project feasibility pertaining to clinical monitoring.
• Assist with defining operational Key Performance Indicators and departmental goals.
• Manage recruitment process for CRAs (and Consultant/Freelance CRAs as applicable), including review of CVs and conducting interviews collaboratively with Human Resources and others.
• Collaborate with other functional areas within CTI to ensure CRA (and Consultant/Freelance CRA as applicable) on-boarding, off-boarding, and project handovers are effective and timely