Medical Project Coordinator

Position Overview

• Location Type: Office
• Job Type: Full time
• Work Schedule: Standard (Mon-Fri)
• Environmental Conditions: Office

A day in the life of this role involves coordinating and reviewing safety data using various tools, identifying trends, ensuring coding consistency, and following up with investigator sites. The role also includes resolving or escalating potential issues, summarizing data for safety review meetings, and potentially reviewing sections of aggregate reports.

Responsibilities

• Coordinate and review safety data utilizing line listings, company dashboard(s) and/or other visualization tools.
• Review data for safety trends, coding consistencies, and potential follow up with investigator sites.
• Identify potential issues and resolve or escalate as appropriate.
• Review safety data and may provide summations for safety review meetings.
• May review designated sections of aggregate reports.
• May help to create/review safety and medical management plan(s) on studies (as applicable) and ensures that the processes included in plan documents are reflective of the contract and services requested.
• May help manage routine project implementation, forecasting and coordination, including review of metrics and budget considerations.
• Monitor the status of data review and escalate any delays and/or risks to all stakeholders, including study leads.
• May present at business development, client, and investigator meetings and participate in strategy/business development calls.
• Resolve complex problems through in-depth evaluation of various factors and offers solutions.
• May serve as the primary point of contact for clinical/data management project teams.
• May assist management in training and mentoring.

Requirements

• Education: Bachelors degree in Nursing or related Health Sciences (Physician's Assistant) or licensed RN.
• Experience: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years), including 2+ years of clinical safety experience (clinical research monitoring, or pharmacovigilance, or a combination of clinical research monitoring and pharmacovigilance).

Knowledge, Skills, and Abilities

• Knowledge of GCPs for medical oversight of clinical trials and SAE processing.
• Knowledge of drug development and safety reporting.
• Knowledge of safety data trending to include coding.
• Working knowledge of biostatistics, data management, and clinical procedures.
• Strong problem-solving and critical thinking skills.
• Good oral and written communication skills.
• Strong attention to detail.
• Ability to work in a collaborative team environment.
• Ability to maintain a positive and professional demeanor in challenging circumstances.