Medical Monitor Contractor - Remote
Select Source International · Pearl River, NY · 1 mo ago
On-siteOTHRContract
About the role
The Medical Monitor Contractor will serve as a critical member of the clinical team, responsible for ensuring the integrity and quality of clinical data and supporting clinical oversight activities. This is a 12‑month contract with possibility of extension, remote work.
Responsibilities
- Serve as a clinical team member assigned to data review for clinicians, including verification of subject eligibility based on medical history.
- Critically apply protocol‑defined study requirements to assess data relevant to study endpoints (safety, tolerability, immunogenicity, efficacy).
- Review serious and non‑serious adverse events (AEs), including drafting and responding to site queries and ensuring accurate and timely reconciliation of safety data.
- Review reactogenicity data in eDiaries or EDC systems to ensure compliance with protocol‑specified safety surveillance and monitoring.
- Assist the Lead Clinician with aggregate data review and interpretation, preparation and management of safety narratives, and slide development for internal and external presentations.
- Participate in safety narrative authoring workflows.
- Support additional study‑related tasks as required: literature reviews, data cleaning, review of training materials, participation in safety surveillance meetings, contributing to PowerPoint creation as needed.
- Be available during normal business hours for the assigned region and work the specified number of hours per week.
- Perform other duties such as eDiary design, feasibility, informed consent document reviews, draft protocol reviews, safety presentations, and site interactions for safety follow‑up or protocol compliance and/or training, based on prior experience.
Qualifications & Skills
- Medical degree (MD, DO, MBBS, or equivalent) required.
- Preferred: at least 2 years of direct patient care experience post‑residency.
- Comfortable with complex medical reviews involving pediatric, adult, and obstetrical populations.
- Prior experience as a medical monitor, including safety data review (non‑serious and serious AEs).
- Experience on an interventional clinical trial within the past 3 years (vaccine trials preferred but not required).
- Familiarity with EDC platforms (RedCap preferred).
- Strong ability to critically evaluate medical/scientific information.
- Understanding of clinical study design, development, and execution.
- Proficiency in Microsoft Word, PowerPoint, and Excel.
- Fluency in English (written and spoken).
- Ability to adapt to a fast‑paced and evolving environment.
- Training and experience in infectious diseases and/or infection control in a hospital setting is preferred.
- Other relevant specialty experiences include: Family Medicine, Internal Medicine, Obstetrics and Gynecology, or Pediatrics.
Schedule
Standard Shift, Monday‑Friday.