Clinical Research Coordinator managing phases of clinical trials under supervision at Perelman School of Medicine. Overseeing study operations, data management, and participant recruitment in a hybrid role.
About the role
- Clinical Research Assistant supporting clinical trials and participant engagement in obesity care at knownwell, Inc. Responsible for patient-facing activities to ensure high-quality experience.
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.
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.
- Basic proficiency with electronic health records (EHR) and/or data entry systems.
Benefits
- 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)
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