Clinical Program Coordinator

Assist Clinical Study Team Leads with preparation, review, handling, distribution, filing, and maintaining clinical research documentation according to standard operation procedures (SOPs).Assist Clinical Trial Master File Specialist in collecting, reviewing and uploading clinical study documentation prior to archival within the electronic Trial Master File (TMF) managed by TransPerfect in accordance with established SOPs.Conduct periodic review of study files for accuracy and completeness.Assist Clinical Study Team Leads to manage documentation by carrying out tasks including but not limited to: ensure checklists and study plans are documented, approved, and filed; maintain GCP and 21 CFR standards; ensure accountability and accuracy of documentation; oversee and ensure electronic data integrity.Assist Clinical Study Team Leads with preparation, handling, distribution, collection, and destruction of clinical trial supplies and maintenance of tracking information for study product accountability.Assist Clinical Operations with the drafting, maintenance, and schedule of review of SOPs.Adhere to all approved client/vendor clinical research related SOPs and working practices.Perform Quality Coordinator duties, to include the administration of QMS tasks including but not limited to: change control, document control, document edits, document drafting, and quality audits.Demonstrate superior communication skills; attention to details; ability to think pro-actively and escalate concerns/ issues in a timely manner; comply with project or task timelines to support overall success in project milestones.