Data Entry Coordinator

2 weeks ago

Escondido, United States Headlands Research Full time
Overview

The Headlands Research - AMCR Institute is dedicated to attracting, nurturing, and retaining patients and staff in order to carry out outstanding metabolic research. Our volunteers, sponsors, partners, and staff enjoy working together in an environment of mutual respect that fosters personal growth and optimal health. We passionately believe that the participation of a few in clinical research studies can make a difference to the many that suffer from chronic metabolic conditions. We strive to be the best at what we do and at all times be meticulous in all our practices placing the care, safety, and confidentiality of our volunteers first. Excellence in clinical research, accelerating access to treatments that change lives.

Together with Headlands Research, we are building the best clinical trial company in the world. We're an exceptional family of next-generation clinical trial sites, integrating cutting edge technology and high-quality support services, and significantly expanding participant outreach and participation. Founded in 2018, Headlands Research is in high growth mode; we operate 18 clinical trial sites in the US and Canada and have rapid expansion plans.

The Role

AMCR is looking for a Data Entry Coordinator to support research study-related activities. This person will be responsible for ensuring day-to-day adherence to protocol, regulatory standards, and established policies and practices to deliver high quality and timely study data.

Position Type: Full-Time

Pay Range: $18-$20/hr

Location: Escondido, CA on-site (no potential for remote or hybrid)

Travel: 0%

Work Schedule: Mondays through Fridays, regular business hours

Responsibilities

  • Enter clinical trial data collected during study visits into various web-based electronic data capture (EDC) programs.
  • Responsible for resolution of data queries.
  • Responsible for following up with clinic staff for outstanding queries.
  • Review all data for errors and report any unusual findings.
  • May perform quality control of source documents and EDC.
  • Adhere to GCP, ICH, HIPAA, FDA Regulations and SOPs.
  • Support the implementation and maintenance of an electronic QMS (eQMS).
    • Support users of eQMS with regards to:
    • Access control
    • Workflow & required approvals
  • Development of training materials
  • Attend study teleconferences and meetings.
  • File study paperwork in regulatory binders as needed.
  • File subject charts in appropriate locked cabinets as needed.
  • Complete accountability logs as needed.
  • Comply with all regulatory requirements.
  • May complete study visit paperwork (known as Case Report Forms, or CRFs) under the guidance and direction of the CTM and/or Study Coordinator.
  • May perform other delegated duties as needed.
  • Regulatory team support in collection, tracking and updating eReg system.
Qualifications
  • High school diploma or equivalent degree is required.
  • Exceptional organizational skills, diligence and follow through.
  • Excellent verbal and written communication skills.
  • Well-developed interpersonal skills and the ability to work well independently as well as with co-workers, peers, supervisors, and external customers.
  • Exceptional knowledge of office computer systems and software
  • Ability to effectively work within record software and update files accurately
  • Must be professional, possess a high degree of urgency and self-motivation, and have a strong work ethic.
  • Must possess a high degree of integrity and ability to maintain confidentiality with patient, customer, and company's sensitive information.
  • High school diploma or equivalent degree is required.
  • Exceptional organizational skills, diligence and follow through.
  • Excellent verbal and written communication skills.
  • Well-developed interpersonal skills and the ability to work well independently as well as with co-workers, peers, supervisors, and external customers.
  • Exceptional knowledge of office computer systems and software
  • Ability to effectively work within record software and update files accurately
  • Must be professional, possess a high degree of urgency and self-motivation, and have a strong work ethic.
  • Must possess a high degree of integrity and ability to maintain confidentiality with patient, customer, and company's sensitive information.

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