Roles and Responsibilities 

Duties include (but are not limited to): 

• Project Management: Oversee defined research activities to meet strategic research needs. Coordinate regularly among external collaborators and internal stakeholders. 

• Compliance: Ensure research activities comply with study protocols, external standards (IRB policy, GCP, regional regulatory requirements, and internal GEHC requirements (Phased Review Discipline, QMS, SOPs),. 

• Team Leadership: Lead cross-functional research teams to conduct internal and external research activities, delivering required outcomes per business needs and study plans. 

• Documentation: Develop necessary research documents, including protocols, plans, informed consent forms, source documents. Maintain investigator site file documentation, including regulatory binders, source documentation, and trackers. Maintain study records in systems like Clinical Trials Management System, MyWorkshop, and regional regulatory records. 

• Budget and Contracts: Negotiate budgets and contracts with external partners and process payments. 

• IRB Submissions: Complete IRB submissions such as new study submissions, Continuing Review, Amendments, Deviation reports, and Adverse Event reports. 

• Staff Training: Conduct training and provide guidance to study staff. 

• Monitoring Visits: Facilitate regular monitoring visits and prepare for audits. 

• Communication: Serve as the main point of contact for research volunteers and study staff. 

• Process Improvement: Implement process improvement activities as needed. 

• Electronic Processes: Implement electronic processes to enhance compliance and efficiency. 

Required Qualifications 

• Bachelor’s degree in life sciences, engineering, clinical field, or equivalent. 
• 5+ years of experience in clinical or technical research programs in a clinical setting, industry, government agency, or a similar role in a medical device or pharmaceutical company. 
• The experience being in managing research projects or medical device research.
• Patient facing experience and experience working in/with sponsored studies
• Strong understanding of Good Clinical Practices (GCP) and global/regional research or device regulations. 
• Proven ability to build and sustain cross-functional relationships. 

Desired:

• Professional certification in Project Management (PMP) or clinical research (CCRP, CCRA, or CCRN)