Clinical Research Coordinator (Data Mgmt and Standards) - Remote

Location
Rockville, Maryland
Salary
Competitive
Posted
May 05, 2023
Closes
Jun 03, 2023
Ref
3790
Function
Analyst, Research
Industry
Science
Hours
Full Time
Clinical Research Coordinator (Data Management and Standards)

US Remote

The Emmes Company, LLC ("Emmes") is a global, full-service Clinical Research Organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation. We believe in the power of truth, so much so that we named our company Emmes, which means truth. Through decades of experience we have learned that collaborative relationships thrive and human health benefits when truth is our compass.

Our "Character Achieves Results" culture is driven by five key values that guide our actions in the way we conduct research and distinguish us as an organization: Integrity, Agility, Passion for Excellence, Collaborative Partnerships and Intellectual Curiosity. We are a trusted partner to clients who share our passion for improving public health in a world of ever-changing scientific research.

If you share our motivations and passion in research, come join us! You will be joining a collaborative culture that empowers every Emmes employee — from entry level through top executive — to contribute to our clients' success by sharing ideas openly and honestly.

Primary Purpose

Work with Essex Management's team to support a large-scale cancer immunology data project which is creating multi-technology cancer data sets for use in clinical trials and research.

Responsibilities

This position involves supervising, tracking, and validating the providence of clinical data and metadata for large-scale cancer omics projects. A qualified candidate would be detail-orientated, clear communicator with significant experience in clinical data management. The individual would participate in data request negotiations with clinical data generating research institutions, would coordinate and document accession of new data, to track and document the life course of that data through QC, analysis, data harmonization, and finally to identify clinical data for inclusion into appropriate clinical analysis. This role also involves issue resolution and communication of the status of data with sponsor and participating sites.

Experience
  • Bachelors degree in Cancer Biology, Molecular Biology, or other related life science field
  • Minimum of 4 years of research experience at a clinical trial site
  • Experience maintaining and developing clinical data standards (CTEP and/or CDISC)
  • Experience working with clinical trial data or knowledge of clinical trial design and data collection
  • Expertise in Cancer Clinical Data
  • Experience negotiating large scale clinical dataset analysis, including with clinical management stakeholders
  • Significant experience with the clinical data standards related to data harmonization and analysis
  • Fluency with Microsoft software applications (Word, Excel)
  • Experience coordinating multi-center study data including the development of clear and data harmonization are required
  • Working knowledge and / or training with NCI data standards repositories preferred
  • Practical knowledge / experience of the data standards of other large national data initiatives preferred
  • Experience with data sharing platforms, including dbGAP and CRDC preferred


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:
  • Unlimited Approved Leave


  • Tuition Reimbursement


  • 401k Retirement Plan
  • Work From Home Anywhere in the US


  • Maternal/Paternal Leave


  • Casual Dress Code & Work Environment


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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.