[Hiring] Clinical Research Coordinator II @SynaptiCure Inc.
Role Description
The Clinical Research Coordinator II (CRC II) plays a critical role in supporting Synapticure’s remote and decentralized research portfolio, including an Expanded Access Program providing investigational treatment for individuals living with ALS. This role is ideal for an experienced research professional who can manage study activities independently while partnering closely with investigators, research leadership, and cross-functional clinical teams.
As a CRC II, you will:
• Oversee day-to-day study execution
• Ensure regulatory and documentation compliance
• Serve as a primary point of contact for research participants and caregivers
• Balance operational rigor with compassion
• Help deliver a seamless, ethical, and patient-centered research experience
Successful candidates are detail-oriented, proactive, and comfortable navigating complex research workflows while supporting patients and families affected by neurodegenerative disease.
Job Duties – What you’ll be doing
• Independently coordinate assigned study activities in compliance with protocols, SOPs, GCP, and regulatory requirements.
• Screen and evaluate potential research participants for eligibility, documenting inclusion/exclusion criteria and escalating complex questions as needed.
• Manage scheduling and execution of virtual and home-based study visits, assessments, and follow-up activities.
• Collect, review, and enter study data accurately and in a timely manner using EDC systems and study tools.
• Maintain complete, accurate, and audit-ready study documentation, including regulatory binders, participant records, and tracking logs.
• Conduct or support informed consent discussions, ensuring proper documentation, version control, and regulatory compliance.
• Serve as a primary point of contact for research participants and caregivers, addressing routine questions and coordinating logistics.
• Prepare for and support sponsor, IRB, and regulatory monitoring visits, including responding to document requests and resolving findings.
• Track and report study metrics such as enrollment, retention, deviations, and visit completion.
• Identify operational risks or inefficiencies and proactively communicate improvement opportunities to research leadership.
• Collaborate closely with investigators, care coordinators, and cross-functional teams to ensure a high-quality research experience.
• Support onboarding and informal mentoring of junior research staff, as appropriate.
Qualifications
• Bachelor’s degree in a scientific, health-related, or behavioral field preferred.
• 2–3 years of experience as a Clinical Research Coordinator or equivalent role.
• Experience working with human subjects research required; neurology, ALS, or decentralized trial experience preferred.
• Working knowledge of GCP, informed consent requirements, and clinical research regulations.
• Ability to manage study responsibilities independently while knowing when to escalate issues.
• Strong organizational skills with the ability to prioritize across multiple studies and deadlines.
• Excellent written and verbal communication skills, including comfort working directly with patients and caregivers.
• Experience using EDC systems, CTMS, electronic health records, and study tracking tools.
• Comfort working in a fully remote research environment using virtual communication platforms.
• Collaborative, adaptable, dependable, and aligned with Synapticure’s mission and values.
Requirements
• Relentless focus on patients and caregivers.
• Embody the spirit and humanity of those living with neurodegenerative disease.
• Seek to understand, and stay curious.
• Embrace the opportunity.
Apply tot his job
Apply To this Job
The Clinical Research Coordinator II (CRC II) plays a critical role in supporting Synapticure’s remote and decentralized research portfolio, including an Expanded Access Program providing investigational treatment for individuals living with ALS. This role is ideal for an experienced research professional who can manage study activities independently while partnering closely with investigators, research leadership, and cross-functional clinical teams.
As a CRC II, you will:
• Oversee day-to-day study execution
• Ensure regulatory and documentation compliance
• Serve as a primary point of contact for research participants and caregivers
• Balance operational rigor with compassion
• Help deliver a seamless, ethical, and patient-centered research experience
Successful candidates are detail-oriented, proactive, and comfortable navigating complex research workflows while supporting patients and families affected by neurodegenerative disease.
Job Duties – What you’ll be doing
• Independently coordinate assigned study activities in compliance with protocols, SOPs, GCP, and regulatory requirements.
• Screen and evaluate potential research participants for eligibility, documenting inclusion/exclusion criteria and escalating complex questions as needed.
• Manage scheduling and execution of virtual and home-based study visits, assessments, and follow-up activities.
• Collect, review, and enter study data accurately and in a timely manner using EDC systems and study tools.
• Maintain complete, accurate, and audit-ready study documentation, including regulatory binders, participant records, and tracking logs.
• Conduct or support informed consent discussions, ensuring proper documentation, version control, and regulatory compliance.
• Serve as a primary point of contact for research participants and caregivers, addressing routine questions and coordinating logistics.
• Prepare for and support sponsor, IRB, and regulatory monitoring visits, including responding to document requests and resolving findings.
• Track and report study metrics such as enrollment, retention, deviations, and visit completion.
• Identify operational risks or inefficiencies and proactively communicate improvement opportunities to research leadership.
• Collaborate closely with investigators, care coordinators, and cross-functional teams to ensure a high-quality research experience.
• Support onboarding and informal mentoring of junior research staff, as appropriate.
Qualifications
• Bachelor’s degree in a scientific, health-related, or behavioral field preferred.
• 2–3 years of experience as a Clinical Research Coordinator or equivalent role.
• Experience working with human subjects research required; neurology, ALS, or decentralized trial experience preferred.
• Working knowledge of GCP, informed consent requirements, and clinical research regulations.
• Ability to manage study responsibilities independently while knowing when to escalate issues.
• Strong organizational skills with the ability to prioritize across multiple studies and deadlines.
• Excellent written and verbal communication skills, including comfort working directly with patients and caregivers.
• Experience using EDC systems, CTMS, electronic health records, and study tracking tools.
• Comfort working in a fully remote research environment using virtual communication platforms.
• Collaborative, adaptable, dependable, and aligned with Synapticure’s mission and values.
Requirements
• Relentless focus on patients and caregivers.
• Embody the spirit and humanity of those living with neurodegenerative disease.
• Seek to understand, and stay curious.
• Embrace the opportunity.
Apply tot his job
Apply To this Job