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Form of workWelcome! At Digital Infuzion, we believe people can lead better, healthier lives. To do so, researchers need insights faster, and providers need on-demand data and tailored software solutions. Which is why we are passionate about developing innovative solutions for the healthcare industry so researchers and providers can better serve their patients. We go beyond ordinary health IT services and solutions because we see the advancement of technology and bioinformatics as opportunities to make meaningful impacts in patient’s lives. If you feel drawn to doing what you love in a creative, open, and growth-oriented environment all while helping people live healthier lives, then keep scrolling - we may have just the opportunity for you.
We’re currently looking to hire a Clinical Research Coordinator (CRC) to provide administrative support to the project team. The CRC will support, facilitate and coordinate the clinical trial activities and plays a critical role in the conduct of studies. The CRC works with the Project Director, and sponsor to support and provide guidance on the administration of the compliance, personnel and other related aspects of the clinical research studies. This research professional will apply their acquired knowledge, skills and subject matter expertise in execution of assigned tasks.
Responsibilities
- Performs administrative tasks on assigned trials including but not limited to timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, distributing mass mailings and communications as needed, providing documents and reports to internal team members.
- Coordinates with Project Director to ensure that clinical research and related activities are performed in accordance with federal regulations and sponsoring agency policies and procedures.
- Assists in the development of materials and tools necessary to appropriately train individuals involved in the conduct of the studies around issues related to (but not limited to)? protocol requirements, schedule of visits, execution of research plan. Maintains documentation of training.
- Assists to ensure personnel engaged have met training requirements.
- Reviews and tracks local regulatory documents and compliance funded clinical studies.
- Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation.
- Assists with coordination, compilation and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites.
- Provide support as needed for protocol drafting and review
- Maintains knowledge of and understands SOPs, client SOPs/directives, and current regulatory guidelines as applicable to services provided.
- Ensures that trial status information relating to activities is accurately maintained in the database and current at all times.
- May support the maintenance of study specific documentation and global support with specific systems, tools and trackers, including, but not limited to, study team lists, tracking of project specific training requirements, system access management for organization/vendor/clients and tracking of project level activity plans in appropriate system. Ensures (e)TMF is up to date by following file review schedules and documenting findings in appropriate system(s).
- May support start-up team in regulatory submissions and assist with the preparation of regulatory compliance review packages.
- May develop site list, including research from internal and external sources to ensure the site list is reflective of the defined site profile. Ensure current investigator and site staff contact details are appropriately maintained in company systems.
- May complete ‘Site Interest Plans” and the collection and delivery of associated documents from investigators and site personnel.
- Assist in the assessment of human subject safety and operational concerns and risks.
- Bachelor’s degree in Healthcare, Science, Business Administration or related scientific, technical, or clinical discipline required. Combination of education and relevant work experience may be considered.
- Experience working within clinical research domain and project coordination or administrative support experience
- Proficient in Microsoft Office software- Access, Word, Power Point, SharePoint, and Outlook
Digital Infuzion, Inc. is an Equal Opportunity Employer. EOE/AA/M/F/D/V
It is the policy of Digital Infuzion, Inc. to provide equal employment opportunities without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, marital status, veteran status, genetic information, or any other protected characteristic under applicable law.
Pursuant to Executive Order on Ensuring Adequate COVID Safety Protocols for Federal Contractors. All applicants should be prepared to show proof of a COVID-19 vaccination upon hire.
