[Hiring] Clinical Research Study Coordinator @National Organization f

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description The Clinical Research Study Coordinator will work collaboratively with the IAMRARE Implementation Lead and Product Owner to support the NORD IAMRARE Patient Registry Program implementing virtual studies.

• Support all aspects of the IAMRARE Registry Program including onboarding, implementation, project launch and ongoing support.
• Provide support on Registry development, working closely with clients to develop their protocols, content for Registry, feature specifications, registry promotion and evaluation.
• Work collaboratively with IT and other departments on the development and implementation of new registries.
• Assess and mitigate risks associated with project implementation including ensuring project timelines and deliverables are met.
• Coordinate and assist with the administration of project meetings.
• Support clients in the development and submission of content for IRB review.
• Manage the development, testing, and launch of surveys, and supports subsequent revisions.
• Train clients and their study staff on using the Registry Platform Program and its features.
• Create and maintain Registry Program resources and tools.
• Respond to clients inquiries and independently resolve issues; liaise with IT and other staff as necessary.
• Serve as dedicated Project Manager for select registry clients.
• Lead the successful execution of online research studies through all phases of the study: planning, enrollment, engagement, retention and close out.
• Responsible for performing research operations in accordance with the study protocol and working in partnership with the Implementation Lead and Product Owner to coordinate research activities.
• Conduct active outreach to deliver or exceed project enrollment targets, establishing rapport with study participants.
• Responsible for accurate and timely data curation in the electronic research study system.
• Develop written project updates and participate in project meetings with NORD research team.
• Demonstrate compliance with good clinical practice (GCP) and applicable law.
• Understand and promote compliance with all applicable research regulations.
• Perform other duties and functions as assigned.

Qualifications

• Bachelor’s degree in science, research, health or a related field required. Advanced degree preferred.
• At least 3 -5 years of clinical research experience working with human subjects is required (coordinating trials, working in a research clinic or academic medical center).
• Excellent organizational skills and project management skills required.
• Experience working with rare disease families preferred.
• Experience managing multi-stakeholder projects in a research, healthcare technology or academic research environment is required.
• Experience working with research or healthcare databases, such as RedCap and SPSS is required.
• Experience managing grants and working with IRB’s and/or ethics committees is required.
• Certification from the Association of Clinical Research Professionals (ACRP) or from the Society of Clinical Research Associates (SOCRA) is preferred.

Knowledge, Skills and Abilities

• Excellent verbal and written communication skills.
• Superior attention to detail, organization, planning, and time management skills.
• Ability to work independently as well as collaborate with team members.
• Excellent technical computer skills, competent with Microsoft Office, Teams, project management software and database software.

Working Conditions

• Fully remote, based in the U.S.
• Essential functions are typically performed in an office setting with a low level of noise. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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