knownwell

Clinical Research Assistant

knownwell

full-time

Posted on:

Location Type: Hybrid

Location: NeedhamMassachusettsUnited States

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Salary

💰 $45,000 - $60,000 per year

Job Level

About the role

  • Serve as a primary point of contact for study participants during on-site visits, providing a welcoming and professional experience.
  • Guide participants through study visit procedures, answering questions and ensuring they feel informed and comfortable throughout the process.
  • Assist in the informed consent process, ensuring participants understand study expectations, risks, and benefits prior to enrollment.
  • Monitor and document participant well-being during visits, escalating any safety concerns to the supervising Coordinator or Investigator promptly.
  • Schedule and confirm participant appointments, sending reminders and managing visit logistics to support timely enrollment and retention.
  • Perform and document vital signs, including blood pressure, heart rate, temperature, respiratory rate, and weight.
  • Conduct electrocardiograms (EKGs) per protocol, ensuring proper lead placement and tracing quality.
  • Perform phlebotomy (blood draws) in accordance with study protocols and applicable safety standards.
  • Administer and document other protocol-specified assessments as trained and permitted by scope of practice.
  • Collect, process, label, and store biological samples (blood, urine, etc.) per study protocol and applicable regulatory requirements.
  • Ensure proper cold-chain handling and timely shipment of samples to central labs or sponsors.
  • Maintain specimen logs and chain-of-custody documentation accurately.
  • Ensure proper disposal of biohazardous materials in compliance with institutional and regulatory standards.
  • Accurately enter study data into the clinical trial management system (CTMS) and/or electronic data capture (EDC) systems in a timely manner.
  • Complete and maintain source documentation for all participant visits, assessments, and clinical activities.
  • Perform basic quality control checks on data entry to ensure accuracy and completeness.
  • Flag discrepancies or missing data to the supervising Coordinator for resolution.
  • Assist in preparing exam rooms and ensuring all equipment and supplies are ready prior to study visits.
  • Support the Coordinator with site initiation, monitoring visits, and closeout activities as directed.
  • Maintain adequate inventory of study supplies and assist with the receipt and storage of study materials.
  • Support study staff training on visit procedures as needed.

Requirements

  • High school diploma or GED required; associate or bachelor’s degree in a health-related field preferred.
  • Medical Assistant (MA) certification, or equivalent clinical training/experience.
  • GCP certification required (or willingness to obtain within 90 days of hire).
  • 1+ years of experience as a Medical Assistant or in a clinical setting required.
  • Prior clinical research experience is preferred but not required, training will be provided.
  • Experience in performing phlebotomy, EKGs, and vital signs in a clinical environment required.
  • Strong phlebotomy skills required.
  • Proficiency in EKG administration and basic clinical assessments.
  • Excellent interpersonal and communication skills; ability to build rapport with diverse patient populations.
  • Strong attention to detail and commitment to accurate documentation.
  • Ability to manage multiple tasks and prioritize effectively in a fast-paced environment.
  • Comfortable working both independently and as part of a multidisciplinary team.
Benefits
  • 💻 Fully remote opportunity
  • 🩺 Medical, dental, and vision insurance
  • 📈 401K retirement plan with company match
  • 🏝️ Up to 20 days of PTO per year + company holidays
  • 👶 Up to 14 weeks of parental leave (12 for non-birthing parents)
  • 🏡 Annual work from home stipend for remote employees
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
phlebotomyEKG administrationvital signs monitoringclinical assessmentsdata entryquality controlbiological sample processingcold-chain handlingchain-of-custody documentationclinical trial management system (CTMS)
Soft Skills
interpersonal skillscommunication skillsattention to detailtime managementprioritizationteamworkindependencerapport building
Certifications
Medical Assistant (MA) certificationGCP certification