Exception Clinical-Scientific- #26-23818

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.
Key responsibilities include:

• Serving as a clinical team member assigned to data review for clinicians including:
  • Verification of subject eligibility based on medical history.
  • Critical application of protocol-defined study requirements to assess data relevant to study endpoints (e.g. safety tolerability immunogenicity efficacy).
• Reviewing serious and non-serious adverse events (AEs) including:
  • Drafting and responding to site queries.
  • Ensuring accurate and timely reconciliation of safety data.
• Reviewing reactogenicity data in eDiaries or EDC systems to ensure compliance with protocol-specified safety surveillance and monitoring.
• Assisting the lead clinician with:
  • Aggregate data review and interpretation.
  • Preparation and management of safety narratives.
  • Slide development for internal and external presentations.
  • Oversight or Participant in safety narrative authoring workflows.
• Supporting additional study-related tasks as required such as:
  • Literature reviews.
  • Data cleaning.
  • Review of training materials.
• Participating in safety surveillance meetings and contributing to PowerPoint creation as needed.
• Being available during normal business hours for the assigned region and working the specified number of hours per week.
• Additional responsibilities may be added based on prior experience including study startup or conduct activities 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.

Note: There is no interaction with regulatory authorities or direct contact with site staff in this role.

• 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.
• Required: 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.

About US Tech Solutions:

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions please visit .

US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race colour religion sex sexual orientation gender identity national origin disability or status as a protected veteran.

AI Statement: By applying you acknowledge that AI-assisted tools may be used during hiring.

#LI-AS140