Study Start-Up Associate II

Emmes Group•Rockville, MD

10d

About The Position

As part of Emmes' centralized Site and Patient Access group, the Study Start-Up Associate II provides administrative support in preparing regulatory submission packages for international clinical trials. The role contributes to expedited study start-ups, creates and maintains trackers and templates, and coordinates project-specific communications with study team members and cross-functional teams. The associate supports regulatory coordination, document collection and review, site activation, and compliance with study timelines and applicable requirements.

Requirements

Bachelor's degree in a healthcare-related field required, or a master's degree in a healthcare-related field preferred.
1–3 years of experience working within pharma and/or a CRO; preferably 1–2 years working on study start-up activities. Equivalent combinations of education, training, and experience are accepted.
Knowledge of clinical research processes related to study start-up and medical terminology.
Strong written and verbal communication skills to express complex ideas to study personnel and 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 across various clinical trials.
Ability to work independently, prioritize, and work in a matrix team environment.
Working knowledge of MS Project, Word, and Excel.

Responsibilities

Create MS Project files to establish study start-up timelines and processes for each country.
Work with team members to prepare regulatory submission packages.
Track and follow up on missing documents.
Prepare and submit applications to Regulatory Authorities, Central and Local IEC/IRBs, and other country-specific bodies for matters such as data protection and import licenses, as required.
Help prepare and coordinate ongoing submissions, amendments, and regular safety reporting and notifications to IECs and regulatory authorities, as required.
Track regulatory documents and assist with regulatory coordination as instructed by other team members.
Assist in reviewing regulatory documents for completeness.
Assist with coordinating translations, such as contracts across the EU.
Assist Senior Study Startup Associates and Study Startup Leads in coordinating with the sponsor to secure authorization of regulatory documents.
Maintain accurate, up-to-date tracking of each site's status in study trackers.
Coordinate with study team members to collect and track essential documents for site activation.
Coordinate with other Study Startup team members on project-specific status, communication, and deliverables.
Work to study timelines, document and escalate study challenges, and communicate updates to the Lead as required.
Maintain quality and regulatory compliance among investigational sites during site start-up.
Provide regular updates to the Lead or Manager and communicate out-of-scope activities.
Perform other duties as assigned.
Comply with all policies and standards.