Lead Dosing Session Monitor
Job description
About the role
In this capacity, you will serve as the primary oversight presence for dosing activities, ensuring that every step of the participant journey is executed with precision and care. You will own the end-to-end management of the participant experience from initial contact through final data lock, safeguarding both data integrity and patient safety at all times. This position requires you to exercise sound judgment and maintain composure when timelines or requirements shift unexpectedly, adapting plans without compromising standards. You will act as the central point of coordination between participants, sites, sponsors, and regulatory bodies, translating complex protocols into clear, actionable steps. Your decisions will directly influence the quality of clinical data and the overall success of the trial. You will foster a culture of collaboration and scientific rigor while upholding the core values that define Adams Clinical. This role is critical in driving operational excellence and ensuring that each dosing session meets the highest ethical and regulatory benchmarks.
Key facts
What you'll do
- Guide potential study participants through screening and consent processes with meticulous, step-by-step confirmation to ensure understanding and compliance.
- Design detailed dosing schedules and visit plans that strictly adhere to protocol requirements while factoring in patient logistics and practical constraints.
- Coordinate closely with clinical trial sites to confirm dosing timelines and proactively resolve scheduling conflicts before they escalate into operational risks.
- Review safety reports and laboratory trend data to recommend appropriate dose holds or adjustments in alignment with protocol specifications.
- Communicate clearly and consistently with sponsors and regulatory contacts regarding dosing timelines, decisions, and any emerging issues that may impact the study.
- Collaborate with operations teams to ensure alignment on inventory levels, shipping logistics, and site capacity to maintain smooth execution across all trial activities.
- Support continuous process improvements by identifying manual steps and documentation burdens, then proposing solutions that enhance efficiency and reduce errors.
- Maintain comprehensive session notes and detailed logs to create a transparent, auditable trail of all decisions and actions taken during dosing sessions.
- Ensure that all participant interactions reflect the highest standards of ethics, confidentiality, and regulatory compliance throughout the trial lifecycle.
- Act as a subject matter expert for dosing procedures, providing guidance to junior team members and contributing to training initiatives when appropriate.
- Monitor real-time trial progress and adjust dosing session plans as needed to accommodate protocol changes or unexpected participant needs.
- Verify that all electronic diary entries and eConsent documentation are complete, accurate, and aligned with study timelines before finalizing session records.
- Liaise with data management teams to validate key data points and resolve discrepancies that could affect the integrity of dosing records.
- Promote a culture of safety and accountability by consistently reinforcing standard operating procedures and encouraging open communication across all stakeholders.
Requirements
- Hold a high school diploma or equivalent credential as the minimum educational requirement for the position.
- Possess demonstrated experience of 3 to 5 years in clinical monitoring or a related trial role within a trial setting.
- Be legally authorized to work in this country without the need for sponsorship or external work authorization support.
- Employment with Adams Clinical is contingent upon successfully passing standard background checks when required.
- Employment is also contingent upon passing drug screening procedures when requested as part of the onboarding process.
- Maintain reliable daily commuting to the Bronx, New York location for all scheduled shifts and dosing sessions.
- Demonstrate a strong commitment to participant safety, data accuracy, and protocol adherence in every aspect of the role.
- Work effectively both independently and as part of a collaborative team in a fast-paced clinical trial environment.
- Follow detailed instructions and protocols consistently, ensuring that all dosing activities are performed correctly and without deviation.
- Communicate professionally with participants, site staff, sponsors, and regulatory representatives at all times.
- Adapt quickly to changing priorities, protocol amendments, or operational challenges without compromising quality or safety.
- Uphold the highest standards of confidentiality and compliance with all applicable regulations and organizational policies.
Nice to have
- Bring prior experience with eConsent processes and electronic diary tools to streamline participant onboarding and data capture.
- Show familiarity with clinical trial management systems and established data validation practices to support accurate record-keeping.
Practical notes
This is a full-time position based in the Bronx, New York. The role requires reliable transportation to the office for scheduled shifts. Employment eligibility without sponsorship is mandatory. All candidates must pass background checks and drug screenings when requested. No specific work hours or deadlines are outlined in the source material beyond the requirement for dependable attendance.