Project Coordinator

Clinical ink; United States; Remote; USD 50,000 - 70,000; Full time

Job summary

Clinical Ink is seeking a Project Coordinator to join our Project Management team based remotely across the United States. The Project Coordinator will be responsible for supporting Project Managers within assigned programs and accounts, including developing plans, timelines, and documentation.

The role involves coordinating change control, planning meetings, and liaising with internal and external teams to meet project objectives.

Qualifications

• Four-year college degree or equivalent combination of education and work experience.
• 1+ years of clinical trials experience in a project management role or equivalent.
• Experience working with clients, ability to communicate to varying levels of personnel.
• Experience working in data collection and management systems.
• Excellent verbal and written communication skills.
• Experience working on global projects and cross-functional teams.
• In depth understanding of clinical trials.
• Working knowledge of software delivery lifecycle and methodology.
• Working knowledge of GCP, ICH guidelines and FDA regulations.

Responsibilities

• Support Project Managers by developing and managing project plans, timelines, communication plans, training plans, data transfer plans, content documents and implementation plans.
• Coordinate and manage the study change control process from initial request to final decision/approval, including documentation and communication.
• Plan and participate in internal and external meetings, including preparing minutes and materials.
• Liaise with internal functional teams and resources to carry out project requirements/tasks.
• Liaise with external teams to achieve project objectives around change controls, translations, content development, and integrations.
• Assist with managing and updating timelines.
• Coordinate with Study Support and Implementation to ensure sites, users, and equipment requests are addressed in a timely fashion.
• Perform configuration activities for identified projects, as needed.

Skills

Client communication

Verbal communication

Written communication

Global projects

Clinical trials knowledge

SDLC knowledge

GCP/ICH regs

Education

Bachelor's degree

Job description

Company Information

Clinical Ink is the global life science company that brings data, technology, and patient science together to unlock clinical discovery. Our deep therapeutic-area expertise, coupled with Direct Data Capture, eCOA, eConsent, telehealth, neurocognitive testing, and digital biomarkers advancement, drive the industry standard for data precision and usher in a new generation of clinical trials. With offices in the United States and Denmark, Clinical Ink is rewriting the clinical development experience.

Job Description

Clinical Ink is seeking a Project Coordinator to join our Project Management team based remotely across the United States! The Project Coordinator will be responsible for supporting Project Managers within assigned programs and accounts. Responsibilities will include:

• Support Project Managers within assigned program/accounts by:
  
  
  
  • Assisting in the development and management of project plans, including timelines, communication plan, training plan, data transfer plan, content documents and implementation plans
  
  
  • Coordinating and managing the study change control process from initial request to final decision/approval, including documentation and communication
  
  
  • Planning and participating in internal and external meetings, including preparing minutes and associated materials
  
  
  • Liaising with internal functional teams and resources to carry out project requirements/tasks
  
  
  • Liaising with external teams to achieve project objectives in and around change controls, translations, content development, and integrations
  
  
  • Assisting with managing and updating timelines
  
  
  • Coordinating and working closely with Study Support and Implementation to ensure sites, users, and equipment requests are addressed and entered in a timely fashion
  
  
  • Performing configuration activities for identified projects, as needed
  
  
  
  

Qualifications

• Four-year college degree or equivalent combination of education and work experience


• 1 + years of clinical trials experience within a Clinical Research Site, CRO or eClinical service provider in a project management role or other equivalent experience


• Experience working with clients, ability to communicate to varying levels of personnel


• Experience working in data collection and management systems


• Excellent verbal and written communication skills


• Experience working on global projects and cross functional teams


• In depth understanding of clinical trials


• Working knowledge of software delivery lifecycle and methodology


• Working knowledge of GCP, ICH guidelines and relevant FDA regulations

Additional Information

Clinical ink is an equal opportunity employer and does not discriminate against otherwise qualified applicants on the basis of race, color, creed, religion, ancestry, age, sex, marital status, national origin, disability or handicap, or veteran status.

www.clinicalink.com