[Hiring] Study Start-Up Associate II @Emmes Group

Role Description

As part of Emmes' centralized Site and Patient Access group, the Study Startup Associate II provides administrative support to other team members on preparation of regulatory submission packages on international clinical trials. Responsibilities include:

• Creates MS project files to establish study start up timelines and processes for each country.
• Works with team members on preparation of regulatory submission packages.
• Tracks and follows up on missing documents.
• Prepares and submits applications to Regulatory Authorities, Central and Local IEC/IRB and other country specific applications such as for Data Protection, Import License etc. as required.
• Helps prepare and coordinate activities related to ongoing submissions, amendments, and regular safety reporting and notification to IEC and regulatory authorities as required.
• Tracks the regulatory documents and assists in regulatory coordination, as instructed by other team members.
• Assists in review of the regulatory documents for completeness.
• Assists with translations coordination, e.g., for contracts across EU etc.
• Assists Senior Study Startup Associate and Study Startup Leads in coordinating with the sponsor to secure authorization of regulatory documents.
• Maintains up to date and accurate tracking on the status for each site in study trackers.
• Coordinates with study team members to collect and track essential documents for site activation.
• Interacts with other team members of Study Startup function on project specific status, communication, and deliverables.
• Works to the study timelines, documents/escalates study challenges, and communicates updates to the Lead as required.
• Maintains quality and regulatory compliance among investigational sites during Site Startup.
• Provides updates to Lead/Manager on a regular basis and communicates any out of scope activities.
• Performs other duties as assigned.
• Complies with all policies and standards.

Qualifications

• Bachelor's Degree in a Healthcare related field Required or Master's Degree in a Healthcare related field Preferred.
• 1-3 years working within pharma and/or CRO, preferably 1-2 years of experience in working on study start up activities. Equivalent combination of education, training and experience Required.
• Knowledge of clinical research process related to study startup and medical terminology High.
• Strong written and verbal communication skills to express complex ideas to study personnel, internal and sponsor team members High.
• Excellent organizational and interpersonal skills High.
• Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities High.
• Ability to manage multiple competing priorities within various clinical trials High.
• Ability to work independently, prioritize and work with a matrix team environment is essential High.
• Working knowledge of MS Project, Word and Excel is required High.

Benefits

• Opportunity to advance global health.
• Work in a culture built on integrity, collaboration, and innovation.