Clinical Trial Administrator

The Clinical Trial Administrator (CTA) fulfils a specialized research role within the Clinical Research department. The CTA supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of a study. This role is responsible for preparing and maintaining Clinical Trial documentation and supervising administrative activities. In performing these duties, the CTA works closely with Clinical Research Associates to support and provide guidance on the administration of all related aspects of a clinical study.

The Clinical Trial Administrator is based in a Kerecis office and reports to the Director of Clinical Affairs. This is a full-time role.

Major Areas of Accountability- Assist in the preparation and maintenance of clinical trial documentation

• Submit clinical trials to institutional review boards/ethics committees

• Cooperate with Clinical Trials Monitors

• Participate in Clinical Trials team meetings

• Conduct correspondence and make telephone contact with study sites

• Reporting ongoing progress to project manager(s)

• Maintain and report identified metrics

• Prepare other study materials, including but not limited to enrollment logs, drug/device accountability logs

• Prepare applicable submission forms and submit updated documents

• Establish and organize study files, including but not limited to study-specific source documentation, regulatory binders and other materials

• Assist principal investigator/site in communication

• Weekly phone calls to each study center to aid shipment of product and other study materials

• Document status of each center’s recruitment, number of screened patients, enrolled patients, and their current week status, dropouts, and patients that have completed the study; all study documents should be uploaded and organized appropriately in SharePoint

• Prepare monthly status updates on study progress for meetings and the Clinical Newsletter

• Prepare agendas and take notes for all Clinical Development team meetings (Project Check-in, Trial Council, Monthly Presentations, etc.)

• Serve as Administrative Secretary of Trial Council

• Submit and process all vendor/site/contractor invoices in a timely manner upon receipt and follow up with Finance and Accounting until approved. Ensure Net 30 payment terms are adhered to

• Submit required POs for study center recruitment and materials for the trial

• Compile study binders for sites and ship them to sites as needed

• Track documentation required for each center and file them appropriately

• Label study material appropriately with designated stickers and Serial Numbers, as needed, to prepare for shipment to sites

• Request Kerecis and control material for study and facilitate shipment of study materials to sites Anticipated travel- Kerecis employees are required to conduct business to the highest ethical and professional standards; comply with applicable laws and regulations, the Advamed Code of Ethics on Interactions with Healthcare Professionals, and company policies.

• Other job duties as assigned Basic Qualifications

• One year of experience as a clinical research coordinator

• Experience managing device or pharmacology trials or evidence of experience/education in clinical studies

• Very good knowledge of the English language (enabling free verbal and written communication and understanding of content related to the field of clinical research)

• Conscientiousness, precision and consistency in carrying out assigned tasks

• High interpersonal skills

• Ability to work with a large team

• High level of motivation and commitment

• High organizational skills (setting priorities and managing multiple tasks)

• Experience with processing payments / invoices through accounting and finance departments

• Openness to new challenges and willingness to continuously improve skills

• Knowledge of ICH GCP principles an asset

• Good knowledge of Microsoft Office suite

• Effective time management

• Communicativeness, ease in establishing contacts

Preferred Qualifications

• Bachelor’s degree in science-related field from an accredited college or university preferred

Base Salary Range: $65,000 - $85,000

This job description is intended to set forth the core functions required for this position and describe the general nature of the work to be performed. It may not contain a comprehensive inventory of all duties, responsibilities, and qualifications required of employees to do this job. Job duties, responsibilities and activities may change or be supplemented at any time as necessary. Kerecis is an Equal Opportunity Employer. 61975