Lead clinical science for late-stage respiratory studies, driving protocol development, data analysis, regulatory documentation, and cross-functional collaboration.
Locations (2)
Somerville, Massachusetts, United States
Andover, Massachusetts, United States
Compensation
$186,000—$279,000 USD
Responsibilities
Serve as clinical science lead and core member of clinical development team for one or more respiratory studies
Support day-to-day study execution, ensuring alignment with protocol, timelines, and regulatory requirements
Act as a key scientific contributor to late-stage protocols and regulatory submissions
Design and develop clinical trial protocols and associated documents
Drive development of clinical components of regulatory documents
Independent study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process.
Locations (2)
Beverly Hills, California, United States
Los Angeles, California, United States
Responsibilities
Independent study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details to the patients, and participating in the informed consent process.
Schedules patients for research visits and procedures.
Documents thoroughly on Case Report Forms (CRFs) the following; changes in patient condition, adverse events, concomitant medication use, protocol compliance, response to study drug.
Maintains accurate source documents related to all research procedures.
Responsible for accurate and timely data collection, documentation, entry, and reporting including timely response to sponsor queries.
Lead planning and execution of complex clinical programs across the Asia Pacific region, driving multi‑country studies and collaborating with global stakeholders.
Responsibilities
Lead planning and execution of complex clinical programs across APAC
Provide strategic direction and leadership to clinical study teams
Partner with cross‑functional core teams and external CROs
Develop and implement clinical study strategies
Manage study operations, timelines, budgets, and performance metrics
Requirements
Bachelor’s degree in a technical discipline
Master’s degree with 8+ years equivalent industry experience
PhD with 5+ years experience
Nice to have: experience managing external CROs for Class II and Class III medical device studies
Nice to have: experience supporting diabetes or digital health studies
Assist in coordinating studies by preparing personnel and materials, protocols, informed consents, amendments and other necessary documents for review by the IRB and Sponsor
Assemble lab kits and/or gather supplies
Collect and label samples as instructed and deliver or process samples in accordance with the protocol, manual of operations, standard operating procedure (SOP) or other work instruction set
Ensure specimens are properly logged, handled and stored
Follow direction of clinical research coordinator or others involved in the clinical research project work
Requirements
High school diploma or equivalent
Bachelor's degree in a related field
Master's degree in a related field
Nice to have: Bachelor's degree in a related field
Supports and coordinates clinical research studies, including data collection, participant scheduling, regulatory submissions, and compliance with federal and local guidelines.
Responsibilities
Coordinate and implement increasingly complex research studies
Collect, evaluate, and abstract clinical research data
Enter and process data into Electronic Data Systems (EDCs)
Complete Case Report Forms (CRFs)
Prescreen and schedule research participants
Requirements
High School Diploma or GED
Nice to have: Bachelor's Degree in Science, Sociology, or a related field
Nice to have: Clinical Research Certification (SOCRA or ACRP)
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