Remote Trial Master File Specialist Jobs in Silver Spring, MD

Sr. In-House CRABe Part of One Team, One Purpose.At Emmes Group, we're shaping the future of clinical research-where human intelligence meets cutting-edge technology to drive meaningful advancements in healthcare. With over 47 years of scientific excellence, we've led groundbreaking research in cell and gene therapy, vaccines, infectious diseases, ophthalmology, rare diseases, and neuroscience.Through our two business units-Emmes, a full-service CRO, and Veridix AI, our technology, data, and analytical solutions -we are modernizing clinical trials and accelerating the development of life-changing therapies.We believe that every clinical breakthrough starts with people-people who are passionate, purpose-driven, and ready to make an impact. At Emmes Group, we bring People, Science, and Technology together to collaborate with our customers and deliver global health impact. Our culture is built on integrity, collaboration, and innovation, ensuring that every challenge is met with perseverance and accountability.The Senior In-House Clinical Research Associate (CRA) is responsible for assisting with operational activities supporting the site management and monitoring of clinical studies/trials, ensuring clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), and all applicable regulatory requirements. The Sr. In-House CRA may assist in program level status tracking and reporting across multiple studies. The Sr. In-House CRA may also be referred to as a Clinical Trial Associate on some contracts.

• Under the high level supervision of the project site management staff oversight lead (i.e., Clinical Trial Manager, Lead CRA, Clinical Project Manager, etc.)
• Possesses working knowledge of the study protocol, site monitoring plan, and study manuals to triage questions or requests from site staff (e.g., enrollment updates, questions, missing documentation, meeting arrangements, etc.).
• Has solid knowledge of Good Clinical Practices and country regulatory requirements.
• Independently collects, reviews, maintains, and tracks required essential documents. Review includes assessment of completeness, accuracy, and compliance with good documentation practices and regulatory and local requirements.
• Performs upload of essential documents into the trial master file.
• Independently communicates and coordinates effectively with internal project staff members and site staff.
• Independently completes IRB/EC submissions for sites or submits to central IRB/EC on behalf of the site.
• Provides project teams with trial progress tracking by updating the Clinical Trial Management System and other software tools.
• Provides mentorship and training to junior staff on the project
• Assists in audit preparation activities as needed.
• Assists the CRA in Issue and Action Item (AI) resolution post visit and assists with tracking AIs to completion.
• Tracks site training
• Tracks site recruitment efforts and collect/review site screening logs.
• Assists with the review of the database to assess data currency and may assist site teams with resolving data queries/discrepancies.
• Reviews site specific language in informed consent forms prior to submission to the IRB/EC.
• Assists with preparing and independently conducts training and retraining of site staff.
• Prepares meeting agendas and meeting minutes.
• May assist in preparing study documents.
• May assist with ordering clinical trial supplies from vendors such as laboratories and Investigational Product depots.
• May assist experienced CRA in the conduct of remote and/or on site monitoring visits such as qualification/pre study visits, site initiation visits, interim/routine monitoring visits, closeout visits, and for cause visits.
• May perform remote review and monitoring of Informed Consent Forms and other source documents.
• May assist with preparation of DSMB meeting materials.
• Performs other duties as assigned
• Complies with all policies and standards

• Bachelor's Degree Scientific discipline preferred, or directly applicable work experience preferred Required
• 1-3 years of relevant clinical research experience, (as a CTA, in-house CRA, study coordinator, etc.) Required
• Proficient with MS Office Suite High
• Excellent computer and organizational skills High
• High attention to detail required High
• Ability to work on varying projects and exercise critical thinking High
• self starter who can work independently and a team player who can work cross functionally with limited oversight High
• Knowledgeable in clinical research operations, including interpretation and implementation of country specific regulations and ICH guidelines, as required High
• Excellent organizational, interpersonal, and communication skills both oral and written High
• Demonstrated problem solving skills, self motivated, and adaptable to a dynamic environment High
• Knowledgeable in prioritization, problem solving, organization, critical thinking, decision making, time management, and planning activities High
• Ability to collaborate with internal and external colleagues and work well in a team oriented setting High

If you're looking for a career where your work advances global health and where scientific excellence meets real-world impact, join us and be part of something bigger. One Team, One Purpose.

Why work at Emmes?

At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our  Emmes Cares community engagement program.   We offer a competitive benefits package focused on the health and needs of our growing workforce, including:

• Flexible Approved Time Off

• Tuition Reimbursement

• 401k Retirement Plan

• Work From Home Anywhere in the US

• Maternal/Paternal Leave

• Casual Dress Code & Work Environment

CONNECT WITH US!

Find us on LinkedIn:/the-emmes-group/Visit our website:https://www.theemmesgroup.com/

The Emmes Company, LLC is an equal opportunity employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to disability or protected veteran status.

#LI-Remote