Clinical Research Assistant / Medical Assistant

Overview

Lightship is a clinical trials service provider leading in increasing access and choice in taking part in research to improve equity for all. We design and conduct studies in partnership with biopharmaceutical companies to accelerate bringing new therapies to market. Our approach is to engage people where they are and support them across their journey in a clinical trial, from first contact to study completion. We work to make it easy, convenient, and safe for people to take part by offering visits in clinic, at home, using our mobile research units, and digital health tools. By transforming the way, we conduct clinical research, we can decrease study timelines and reduce dropouts to accelerate development of better therapies.

A successful candidate will possess a willingness and desire to work independently without significant supervision. Lightship expects each individual to anchor their availability in the standard operating hours for their geographic location, however, true to our values of inclusion and flexibility, this role, along with all others at Lightship, may be asked to flex work hours to accommodate US West Coast, US East Coast, and UK-based time zones, based on business need. In practice, this may translate to days that have a slightly earlier start or evenings that have a slightly later end. Culturally, we aim to balance the ability to operate across time zones with respect for each individual's daily life.  

Additionally, this position is a full-time, 6-month contract with potential to extend; On-Site Monday – Friday, 40 hours per week.

The Clinical Research Assistant / Medical Assistant is responsible for:

• Coordinate and execute clinical research studies from start-up through close-out, including feasibility, site selection, regulatory submissions, subject recruitment, and data collection.
• Serve as the primary liaison with central IRBs, managing submissions, renewals, amendments, and responses to queries.
• Independently manage all phases of clinical trials, maintaining compliance with Good Clinical Practice (GCP) and institutional/SOP standards.
• Recruit, screen, consent, and enroll study participants per protocol.
• Perform and document phlebotomy procedures and handle biological specimens per IATA shipping standards.
• Maintain regulatory and study documentation including case report forms (CRFs), electronic data capture (EDC) systems, and source documents.
• Monitor and report adverse events; ensure accurate and timely documentation of protocol deviations.
• Organize and conduct pre-study site initiation visits, interim monitoring visits, and close-out visits with sponsors and CROs.
• Handle investigational product accountability and coordinate with clinical pharmacies as needed.
• Educate participants on study protocols, medications, and visit schedules.
• Ensure timely resolution of sponsor and monitor queries, audits, and action items.
• Other responsibilities as applicable and assigned.

The Clinical Research Assistant / Medical Assistant has:

• Required knowledge, skills, and abilities
  • Strong communication, organizational, and problem-solving skills.
  • Proficient in phlebotomy, including venipuncture and specimen processing.
  • Demonstrated ability to work independently and manage multiple clinical trials concurrently.
  • Strong knowledge of clinical research processes, FDA regulations, and IRB compliance.
• Education and experience
  • Bachelor’s Degree in Life Science or healthcare-related field, or requisite combination of education, training, and experience
  • At least three (3) years of sponsored clinical research experience, required preferably in Allergy/Immunology
  • Current GCP and IATA certifications
  • Proven study start-up experience, including central IRB submission and regulatory binder creation
  • Experience using CTMS, EDC systems, and Microsoft Office Suite

We would like to offer you:

• An opportunity to help re-envision how clinical research is executed with inclusivity, increased diversity and accessible at the core
• The chance to work with a patient-centered, clinically-oriented, collaborative team to support in the delivery of enterprise grade virtual-first clinical research solutions at scale
• An unmatched opportunity to grow as part of an established startup with industry veterans, high-caliber investors, and a massive market opportunity

The annualized base salary range for this role is based on education, skills, and experience.  To determine our compensation, we use a market-based approach that is geographically neutral. We believe that this demonstrates our company value of ‘believing in people’ – valuing the outputs and performance of each team member.

Please note: For the safety of our patients and each other, all positions at Lightship that require travel, in-person participation, or are patient-facing, do require vaccination against COVID-19.

Our commitment to diversity & inclusion:

Lightship is an equal opportunity employer and promotes a diverse and inclusive workplace. Lightship considers all applicants without regard to race, color, religion, creed, national origin, age, sex, marital status, ancestry, disability, veteran status, gender identity, genetic information, sexual orientation, or any other status protected by applicable law.  EEO is the Law

Lightship is an E-Verify employer. Find out more here: Right to Work PosterE-Verify Participation Poster

#jobs #careers #nowhiring #hiringnow #LI-remote