Clinical Study Coordinator

Location
Remote
Salary
Competitive
Posted
May 19, 2022
Closes
May 21, 2022
Ref
3388
Function
Other
Industry
Science
Hours
Full Time
Study Coordinator

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

Work together with Casimir's multidisciplinary team to conduct research using qualitative and quantitative methods. Facilitate and coordinate the daily study activities and play a critical role in the conduct of the study.

Responsibilities
  • Ensure execution of studies with adherence to local and federal regulatory authorities, International Council for Harmonisation (ICH) Good Clinical Practices (GCP), organizational standard operating procedures (SOPs), and study protocols.
  • Recruit, screen, and enroll participants.
  • Complete and manage source documents for all participants.
  • Communicate with participants.
  • Communicate and collaborate with study team members to ensure integrity of data collection and study execution.
  • Coordinate and conduct interviews and data collection (e.g. questionnaires, surveys, medical records and audio and video data).
  • Complete data query resolution via appropriate electronic platforms/systems.
  • Ensure that the Trial Master File (TMF) is set up and maintained appropriately throughout the trial, including periodic reviews.
  • Assist with study close-out documentation.
  • Complete, manage and document incentive distribution.
  • Maintain meeting minutes, as applicable.
  • Work cross-functionally to ensure program timelines and goals are met.
  • Assist in operational improvement initiatives (e.g. SOP development, training, etc.).


Experience
  • A Bachelor's degree in science or related field is required
  • A minimum of one (1) to three (3) years of experience as integral team support for clinical trials for or within the biotech or pharmaceutical industry, including Contact Research Organization (CRO)/vendor management, protocol, informed consent form (ICF) development and review and knowledge of basic data management
  • Knowledge of global clinical trial management in fast paced CRO outsourced environment, including interpretation and implementation of Food and Drug Administration (FDA) regulations/ICH guidelines is required
  • Prior experience with early phase, qualitative research methods, and dose escalation/Proof of Concept study management is preferred
  • Excellent oral and written communications
  • Ability to work remotely, flexibly, and independently while meeting project deadlines
  • Strong technical skills, including knowledge of Microsoft Suite, storage applications, and online audio and video conferencing systems
  • Excellent organizational and priority management skills with ability to work within established timelines, in a fast-paced environment
  • Strong interpersonal skills and ability to interact with people at all levels with sensitivity and tact


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!

Follow us on Twitter - @EmmesCRO

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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