Clinical Trials Administrator Analyst I

US Remote

Emmes Group: Building a better future for us all.

Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.

We believe the work we do will have a direct impact on patients’ lives and act accordingly. We stive to build a collaborative culture at the intersection of being a performance and people driven company. We’re looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us!

Primary Purpose

This position supports "Essex, a Veridix AI company". Essex is a biomedical informatics and health information technology-focused consultancy founded in 2009 and headquartered in Rockville, MD. The Essex team comprises experts with extensive experience in strategically developing and managing complex health and biomedical information programs for clients in the Federal Government, research academia, and private sectors.

The Clinical Trials Administrator (CTA) Analyst reports into the Reporting and Compliance Team Lead and is responsible for handling the registration and monitoring of NCI Sponsored trials and facilitating the results reporting process associated with clinical trials reporting. They ensure timely and accurate data entry information, adhering to established program quality standards.

• Ensuring the management of the NCI’s ClinicalTrials.gov account to monitor and ensure Food and Drug Administration Amendment Acts (FDAAA) and NIH Policy compliance for all NCI Sponsored trials.
  a. Support the registration and monitoring of NCI Sponsored trials.
  b. Support ensuring compliance with the facilitation of the results reporting process for all NCI Sponsored trials.
  c. Troubleshoot and appropriately report unexpected problems that may arise during the registration and/or results reporting process.
  d. Support the management of results review and approval by the appropriate division and release of the results to NLM once approval has been granted.
  e. Support the monitoring of the daily PRS Protocol Upload Notification email for error and issue resolution.
• Ensuring timely responses to inquiries and resolve issues submitted to an issue/ticketing system by the cancer research community or stakeholders, utilizing effective communication.
• Supporting timely reviews and maintenance of Standard Operating Procedures (SOPs) and User Guides.
• Review documents, validate trial information, abstract relevant protocol or scientific data, and perform quality control checks following standard guidelines/SOPs.
• Participating in User Acceptance Testing (UAT) to support application releases.
• Perform related duties as assigned.

• Passionate; enjoys working in a fast-paced, collaborative environment.

• Ability to multitask and handle multiple responsibilities simultaneously; able to prioritize.

• Highly detail-oriented with special attention to quality and quality control.

• Exceptional written and oral communication skills with demonstrated expertise with grammar, syntax, and format.

• Ability to work and learn in a busy setting, both independently and within a team.

• Proficient with computer usage and Microsoft Office applications.

• Work for this position must be performed in the United States (required). Candidates local to Rockville, MD are preferred.

• Applicants selected for this position will be subject to a government security investigation and must meet eligibility requirements for Public Trust positions. Visa sponsorship is not available.

• Successful applicants will be required to travel to an NIH-designated facility for security badging within 60 days of hire. Expenses will be reimbursed.

• Bachelor’s Degree
• A minimum of two (2) years’ experience in a pharmaceutical, biotechnology and/or clinical environment which includes medical and regulatory technical writing/editing (Desired)
• Familiarity with area of clinical trials, both interventional and non-interventional (Desired)
• Experience with ClinicalTrials.gov and the Clinical Trials Reporting Program (Strongly Desired)

• Work for this position must be performed in the United States (required). Candidates local to Rockville, MD are preferred.

• Applicants selected for this position will be subject to a government security investigation and must meet eligibility requirements for Public Trust positions. Visa sponsorship is not available.

• Successful applicants will be required to travel to an NIH-designated facility for security badging within 60 days of hire. Expenses will be reimbursed.

Emmes requires all US based Clinical Research Associate new hires to be fully vaccinated before their first day of employment. All new hires may also be required to comply with other COVID-19 health and safety protocols, such as masking or testing. Emmes complies with all applicable laws regarding reasonable accommodations or exemptions for religious, medical, or other legally protected reasons.

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:

CONNECT WITH US!

Follow us on Twitter - @EmmesCRO

Find us on LinkedIn - Emmes

The Emmes Company, LLC is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.