Clinical Research Assistant

knownwell•Needham, MA

1d•$45,000 - $60,000•Hybrid

About The Position

The Clinical Research Assistant (CRA) plays a vital hands-on role in the execution of clinical trials, serving as a key point of contact for study participants throughout their research journey. Working under the direction of the Clinical Research Coordinator and/or Clinical Research Manager, the CRA is primarily responsible for patient-facing activities, including study visits, specimen collection and processing, data entry, and clinical assessments. This role ensures that participants receive high-quality, consistent experience while supporting the accurate and compliant execution of study protocols.

Requirements

High school diploma or GED required; associate or bachelorâs 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.
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.
Basic proficiency with electronic health records (EHR) and/or data entry systems.
Ability to stand, walk, and move throughout the clinical site for extended periods.
Ability to lift and carry study materials (up to 30 lbs).
Comfortable with routine exposure to biological samples and clinical environments.
Occasional local travel may be required for site visits, training, or meetings.

Nice To Haves

Prior clinical research experience is preferred but not required, training will be provided.

Responsibilities

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.