Responsible for direct contact with study sites, to provide support and problem resolution, throughout the duration of study. To provide these services with an exceptional level of customer service performance, as required by study sponsor and UBC Management.
Specific Job Duties:
• Working knowledge of protocols.
• Contact investigative sites to assess interest in study participation.
• Send required study enrollment documents to interested sites/investigators.
• Assist investigative sites in completing study enrollment documents.
• Collect study enrollment documents.
• Assist investigative sites with study logistic issues, (kits, supplies, drug, etc.)
• Contact investigative sites to assess enrollment/screening activity.
• Collect/receive log and triage adverse event (AE), and study endpoint documents.
• Contact investigative sites to resolve queries on submitted Data Collection Forms (DCFs), as assigned to do so.
• Assist investigative sites in process for completing Data Collection Forms, as assigned to do so.
• Maintain site contact documentation in assigned databases and paper files.
• Attend Clinical Communications team meetings, as needed.
• Provide assistance to all parties who contact the Clinical Coordinating Center, i.e., pharmaceutical reps., prospective investigator sites, enrolled investigator sites, etc.
• Provide in-house support for project teams.
• Assist in the training of new Clinical Communications Specialists.
• Make recommendations for improvement to Project Manager and UBC Management.
• Other duties as assigned by Project Manager and project/UBC specific SOPs
• BS/BA or a comparable degree in a related field or equivalent work related experience, focus in Life Sciences/Nursing is desirable
• Previous customer service experience, medical background preferred
• Ability and willingness to perform increased number and frequency of complex communications, and if necessary, be available during all working hours to take calls from assigned sites.
• Good written and verbal communication skills
• Demonstrates proficient computer skills
• Good interpersonal skills, ability to multi-task as necessary
• Solid organizational skills and attention to detail are required
• Working knowledge of clinical drug development and clinical trial operations