In-House CRA - Remote (Full-time or Part-time)

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In-House Clinical Research Associate

US Remote Worker

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

The In-House Clinical Research Associate will assist in activities suporting the site management and monitoring of clinical studies, ensuring clinical trials are conducted, recorded, and reporting in accordance with the protocol, standard operating procedures (SOPs), and all applicable regulatory requirements.

Responsibilities
  • Reviews daily clinical research status and determines daily tasks
  • Possesses detailed and current knowledge of the study protocol, site monitoring plan, study manuals, Good Clinical Practices, and country regulatory requirements.
  • Collects, reviews, maintains, and tracks required site-level essential documents. Review includes assessment of completeness, accuracy, and compliance with regulatory and local requirements.
  • Independently performs upload of site-level essential documents into the trial master file.
  • Communicates and coordinates effectively with internal project staff members and site staff, and is comfortable communicating with sponsors, clients, and other external colleagues if/as delegated.
  • Reviews database to assess for data currency and independently resolves data queries/discrepancies.
  • Independently performs remote review and monitoring of Informed Consent Forms and other source documents as needed.
  • Reviews site-specific language in informed consent forms prior to submission to the IRB/EC.
  • Completes IRB/EC submissions for sites or submits to central IRB on behalf of the site.
  • May assist with site contract/budget communications in collaboration with Clinical Study Manager, contracts department, or others.
  • Assists with site activation processes in collaboration with clinical operations counterparts.
  • Under the direction of the CRA Manager, Clinical Study Manager, or Lead CRA, may contact and serve as the primary point of contact for clinical sites for study-specific requests (e.g., enrollment updates, questions, missing documentation, meeting arrangements, etc.).
  • Assists project teams with trial progress tracking by updating the Clinical Trial Management System and other tools.
  • May conduct remote and on-site monitoring visits such as qualification/pre-study visits, site initiation visits, interim/routine monitoring visits, closeout visits, and for-cause visits.
  • Drives Action Item (AI) resolution post visit and tracks AIs to completion.
  • Tracks project CRA deliverables such as confirmation memoranda and site visit reports.

Experience
  • Bachelor's degree, preferably in a scientific discipline, or directly applicable work experience may be considered in lieu of degree
  • Prior clinical research experience preferred
  • Previous CRO experientce preferred
  • Basic understanding of regulatory obligations for a Clinical Research Associate and relevant ICH guidelines
  • Skilled in prioritization, problem-solving, organization, critical thinking, decision-making, time management and planning activities
  • Self-motivated and high attention detail required
  • Ability to collaborate with internal and external colleagues and work well in team-oriented setting
  • Excellent oral and written communication; exceptional interpersonal skills
  • Self-starter with ability to work remotely with a high degree of independence
  • Skilled in data management/computer proficient in Microsoft Office


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 & Profit Sharing Plan
  • Work From Home Anywhere in the US


  • Maternal/Paternal Leave


  • Casual Dress Code & Work Environment


CONNECT WITH US!

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Find us on LinkedIn - The Emmes Company, LLC

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.

Emmes is a federal government contractor and requires all employees to be fully vaccinated against COVID-19, to the extent permitted by applicable law. Individuals with medical conditions or sincerely religious beliefs or practices that prevent them from getting the vaccine may request an exemption from the vaccine requirement.

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