Job Description

Study Startup Coordinator (SSC) coordinates study and site startup activities on a country, regional, and project level, starting from handover to Operations until all sites are activated. We are looking for someone with Informed Consent Form review experience (ICF Reviewer) to join our Study Start Up group. 

SCOPE OF RESPONSIBILITIES:

This Study Startup Coordinator role would function as an Informed Consent Form Reviewer:

1. Review site specific Informed Consent Forms for a) accuracy and completeness as required by ICH/GCP and for b) deviations from master/global ICF and protocol
2. Negotiate ICF language as needed in accordance with ICH GCP and all applicable regulations, laws and other guidelines and ethical standards
3. Complete ICF QC checklist
4. Liaise with other stakeholders like the sponsor, legal, or the project team to ensure that changes to the ICF are acceptable.
5. Update site ICF status and tracking ICF review cycles in CTMS
6. Filing final ICF and QC checklist in TMF
7. Assist in the drafting of ICF country templates for the United States and Canada as applicable  
8. Assist in developing and updating local instructions and guidelines related to site ICF review process

Experience must include performing ICF review as an essential function of the job.

ADDITIONALLY, THE SSC WOULD ACT AS AN IP RELEASE ENABLING DOCUMENTS (IP-RED) QC REVIEWER: 

1. Perform QC of IP-REDs on the ongoing basis per PSI IP-REDs Minimum Acceptance Criteria
2. Monitor performance metrics for IP-RED approval
3. Assist in creating and accomplishing regional benchmarks for IP-RED approval at first submission
4. Assist in developing and updating local instructions and guidelines related to IP-RED QC process
5. Perform training for project team members tailored to IP-RED proces

Qualifications

EDUCATION

• Minimum 12 months industry experience in clinical research in an administrative role
• Knowledge of FDA guidelines and ICH GCP

TRAINING

1.  PSI Clinical Trial Coordinator induction course
2.  Customized training relevant to the scope of responsibilities (individually tailored) including training in project specifics and all applicable procedures and regulations
3.  Proficiency in Microsoft Office (including MS Word, Excel, PowerPoint, Project)
4.  Excellent communication and interpersonal skills
5.  Attention to detail
6.  Organization skills
7.  Ability to work in a team or independently

Additional Information

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