Job Description

Job Title: Lead Clinical Research Associate (Cmed CRS)

Reports To: Director, Clinical Operations

Department: Clinical Operations

Core Responsibilities

• Oversee and provide direction to Clinical Research Associate(s)


• Assist with study site management


• Coordinate all monitoring activities and communicate the progress of these activities to the Director, Clinical Operations and/or Head of Operations

Principal Accountabilities

• Communicate the Project Plan and timelines to the monitoring team


• Direct the monitoring team in identifying and recruiting Investigators for a specific clinical trial (subject to contractual requirements)


• Develop study specific Informed Consent for review and approval by the Sponsor (subject to contractual requirements)


• Manage the process for collection, review, and approval of regulatory documents associated with clinical trials (subject to contractual requirements); assure that clinical trial investigational sites obtain regulatory approval of study specific documents


• Conduct periodic site file reviews to ensure that study Monitors are maintaining essential documentation for their respective sites during the clinical study


• Conduct periodic tandem monitoring visits to evaluate sites and Monitors.


• Conduct periodic Trial Master File review


• Assure adherence to Good Clinical Practice, Investigator integrity, and compliance with all study procedures


• Review in conjunction with clinical and/or Data Managers, the quality and integrity of the clinical data through onsite source verification and in house review of electronic CRF data


• Responsible for negotiations with outside Vendors/Contractors when necessary


• Work directly with Clinical Project Manager/ Director, Clinical Operations to ensure that all clinical monitoring activities are conducted on time and within budget, and develop/utilize tracking forms for project team organization


• Provide leadership to monitoring team and identify any performance, resource or other issues and communicate these to the Director, Clinical Operations in a timely manner


• Review monitoring trip reports, follow-up letters and phone contacts generated by the clinical team


• Assist in the update and maintenance of the Clinical Trial Management System (CTMS)


• Assist in the preparation of protocols, protocol amendments, eCRFs, study manuals and other related documents during the implementation of studies


• Attend and assist in both client and internal teleconferences, taking Minutes as required


• Assist as necessary with allied departments e.g. Data Management, SAS Programming, Timaeus support, Business Development, Quality Assurance


• Attend and present at client meetings, including Bid Defenses, as required

Essential Work Experience and Qualifications

• Degree in scientific or related discipline or equivalent relevant experience


• 3-5 years Clinical Monitoring experience


• Previous practical experience in conducting clinical pharmaceutical research in a hospital setting, pharmaceutical company or CRO


• Sound basic knowledge of medical and pharmaceutical industry terminology

Cmed Core Values

All Cmed employees are required to exhibit and demonstrate the Cmed ‘Core values’.

• Client focus: Satisfaction and Solutions


• Dependability: Competence and Quality


• Trustworthy: Open and Honest.


• Innovative: Approaches and Technology