Study Start-Up Associate II

Emmes Group•Rockville, MD

6d•Remote

About The Position

As part of Emmes' centralized Site and Patient Access group, the Study Start-Up Associate II provides administrative support to other team members on preparation of regulatory submission packages on international clinical trials. Gets involved in creation, filing, and updating of trackers and templates and assists in expedited startups and coordinates with other study team members on project specific communication. Liaise with cross functional teams as required.

Requirements

Bachelor degree Life Sciences, Health Sciences, Nursing, or a related field required.
1 to 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.
Knowledge of clinical research process related to study startup and medical terminology.
Strong written and verbal communication skills to express complex ideas to study personnel, internal and sponsor team members.
Excellent organizational and interpersonal skills
Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities.
Ability to manage multiple competing priorities within various clinical trials.
Ability to work independently, prioritize and work with a matrix team environment is essential.
Working knowledge of MS Project, Word and Excel is required.

Nice To Haves

Master's Degree MS, MPH, PharmD (Preferred)

Responsibilities

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 follow up on missing documents.
Prepares and submits applications to Regulatory Authorities, Central and Local IEC/IRB and other country specific application 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 assist 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.