Study Coordinator

3 weeks ago

Rockville, United States The Emmes Company, LLC Full time
Overview

Study Coordinator - Temporary Part-Time

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 strive 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

The Study Coordinator works together with a multidisciplinary team to conduct research using qualitative and quantitative methods. This position facilitates and coordinates the daily study activities and plays a critical role in the conduct of the study.


Responsibilities

  • Ensures 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.
  • Completes and manages source documents for all participants.
  • Communicates with participants.
  • Communicates and collaborates with study team members to ensure integrity of data collection and study execution.
  • Completes data query resolution via appropriate electronic platforms/systems.
  • Ensures that the Trial Master File (TMF) is maintained appropriately throughout the trial, including periodic reviews.
  • Assists with study close-out documentation.
  • Completes, manages and documents incentive distribution.
  • Maintains meeting minutes, as applicable.
  • Performs other duties as assigned.

Qualifications

  • Bachelor‘s degree in science or related field is required.
  • 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 Contract 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.

  • 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.

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.

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