In-House Clinical Monitor

Luminate Medical•New York, NY

10d•Onsite

About The Position

Luminate is seeking an In-House Clinical Monitor to ensure the quality, compliance, and successful execution of clinical trials. This role involves independently conducting monitoring visits at clinical sites, performing detailed source data review and verification, documenting and communicating findings, and ensuring adherence to study protocols, GCP, and regulatory requirements. The position is hands-on, sponsor-side, requiring attention to detail in source records, identification of inconsistencies, and collaboration with sites for resolution. This is a key hire in the Clinical Operations Department at a growing startup, offering direct responsibility for monitoring activities across pivotal and early-stage trials. The role involves working closely with internal teams like Clinical Operations, Data Management, and Quality to ensure high-quality data, and collaborating with a team that values independent judgment and problem-solving.

Requirements

Bachelor's degree in Life Sciences, Nursing, Health Sciences, or a related field.
Minimum 3–5 years of direct, hands-on clinical monitoring experience within the medical device, biotechnology, and/or pharmaceutical industry.
Demonstrated experience independently conducting on-site clinical monitoring visits, including IMVs.
Demonstrated experience performing comprehensive Source Data Review and Source Data Verification, including experience with 100% SDV.
Prior experience independently preparing high-quality Monitoring Visit Reports and site follow-up letters.
Experience with investigational product and/or medical device accountability.
Proficiency with Electronic Data Capture (EDC) systems and clinical data review.
Strong understanding of GCP and applicable FDA clinical research regulations.
Strong written communication and documentation skills.
Ability to independently prioritize and manage multiple sites and monitoring activities.
Willingness and ability to travel approximately up to 50% during active clinical trial periods, based on study needs.

Nice To Haves

Medical device clinical trial monitoring experience.
Experience in the Oncology therapeutic area.
Experience supporting interim analyses and database-lock readiness.
Experience working directly for a Sponsor company.
Experience within startups.
Strong site relationship management skills.
A passion for working in small, entrepreneurial environments where everyone wears multiple hats.

Responsibilities

Perform comprehensive Source Data Review (SDR) and Source Data Verification (SDV), including 100% SDV where required by the study Monitoring Plan.
Review source documentation to identify potentially missing or underreported adverse events, protocol deviations, treatment interruptions, device deficiencies, or other clinically relevant study information.
Review investigational device accountability, including device receipt, assignment, use, replacement, storage, return, and disposition.
Prepare clear, comprehensive, and timely Monitoring Visit Reports and site follow-up letters, documenting findings, required actions, and resolution timelines.
Track monitoring findings and action items through documented resolution and ensure previously identified findings are appropriately addressed during subsequent monitoring activities.
Proactively identify and escalate significant or recurring compliance concerns, data quality issues, protocol deviations, training needs, and risks to participant safety or study integrity.
Work directly with site investigators and research staff to resolve monitoring findings and provide targeted retraining where needed.
Collaborate closely with Clinical Data Management to resolve data discrepancies and outstanding queries and support data cleaning activities.
Support targeted monitoring and data review activities in preparation for interim analyses, database locks, audits, and regulatory inspections.
Act as a knowledgeable representative of Luminate Medical and develop a strong understanding of Luminate devices, clinical protocols, and study procedures.
Contribute to the development and continuous improvement of monitoring tools, templates, processes, and SOPs as Luminate's clinical portfolio grows.