Site Support Services - CRC (COMP005)

Description:

Clinical Research Coordinators (CRC) perform protocol specific duties relevant to the clinical trial in a defined scope that assists the site with patient recruitment.

Scope of Support:

• Administrative Support customized site level support, such as support with regulatory document submissions and perform chart reviews/EMR interrogation
• Prescreening including review of concomitant meds, medical history, and inclusion/exclusion criteria to identify potential patients
• Scheduling Visits including appointment reminders
• Data Entry and Query Resolution based on data available in source documents and ensure data entry and responses are completed within protocol designated windows
• External Referral Outreach including grassroots effort to distribute study recruitment materials in and around sites, community outreach
• Contact, prescreen, and schedule referrals from outreach campaign
• Conduct Study Visits
• Perform ICF process following GCP

Qualifications and Functions for this Role:

• BS/BA in life sciences or educational equivalent and/or relevant work experience in a clinical environment or medical setting
• Minimum 3 years in Clinical Research and preference for relevant healthcare experience
• Certification of CCRC or CCRP preferred
• Experience of EDC entry and query resolution preferred
• Knowledge of clinical trials, combined with in-depth knowledge of departmental, protocol and study-specific operating procedures, consent forms, and study schedules
• Comprehensive knowledge of GCP and ICH guidelines
• Excellent interpersonal skills with the ability to establish and maintain effective working relationships with co-workers, managers and clients
• Preference for Phlebetomy Certification