Clinical Trial Project Coordinator

SystImmune, Inc.; Princeton (NJ); On-site; USD 60,000 - 90,000; Full time

Benefits offered by this job

100% paid employee premiums (medical/d

Dental/vision insurance

401(k) with company match

15 PTO days per year

11 paid holidays

Job summary

SystImmune, Inc. in New Jersey is seeking a Clinical Project Coordinator to support trial management activities at our Princeton site. You will help manage documentation, communicate with CROs, vendors and investigators, and assist start-up activities.

The role requires a Bachelor’s degree in health science, strong communication and organizational skills, and 2 years of research experience; NJ residency or ability to commute to Princeton, with travel as needed.

Qualifications

• Bachelor’s degree in health science or related field.
• 2 years in research experience preferred.
• Excellent verbal and written communication skills required.
• Excellent organizational, multi-tasking and time management skills required.
• Working knowledge of International Conference on Harmonization Good Clinical Practice guidelines.
• Experienced in Microsoft Office Products (Word, Excel, PowerPoint, SharePoint, Teams) and other clinical trial systems (e.g., CTMS, EDC and eTMF)
• Located in NJ or can commute to Princeton, NJ
• Ability to travel as required.

Responsibilities

• Develop and distribute meeting agendas, minutes and monthly status reports to document key project updates and communications to relevant stakeholders.
• Participate in regular team meeting / teleconferences; CRO, Vendor and Investigator Site meetings as necessary; and Investigator Meetings, as necessary.
• Support Clinical Project Management team in communication to CRO, Vendors and Investigator Sites.
• Support the Clinical Project Management team with study start-up activities, to include preparing and/or reviewing study-related documents (e.g., Monitoring Plan, Laboratory Manual, Clinical Site Procedures Manual, Pharmacy Manual, and CRF Completion Guidelines, study logs and forms Site Contracts and Budgets, Vendor Contracts and Budgets, etc.).
• Support the Clinical Project Management team in the tracking of subject recruitment at all study sites; monitoring visits and approval; infringements, breaches, and misconduct, fraud, and negative trends and protocol deviations. Notify CRO and sites of updates on global study information.
• Assist Clinical Project Management team in the collection, review and filing of site Essential Documents, and maintenance of the TMF.
• Assist in the tracking of clinical supplies at site in coordination with established systems such as IWRS, EDC and CTMS as needed.
• Support the Clinical Project Management team in formal risk assessment activities; review and corrective action plans across study, participates in the planning of quality assurance activities, internal and external audits/inspections, and coordinates communication of audit/inspection findings.
• Communication and support Clinical Project Management team with cross-functional study team interaction.
• Perform other duties as assigned.

Skills

Communication skills

Organizational skills

GCP knowledge

MS Office / Office 365

CTMS / EDC / eTMF familiarity

Travel readiness

Education

Bachelor’s degree in health science

Tools

CTMS

EDC

eTMF

SharePoint

Teams

Job description

SystImmune, Inc. in New Jersey is seeking a Clinical Project Coordinator to support trial management activities at our Princeton site. You will help manage documentation, communicate with CROs, vendors and investigators, and assist start-up activities.

The role requires a Bachelor’s degree in health science, strong communication and organizational skills, and 2 years of research experience; NJ residency or ability to commute to Princeton, with travel as needed.