MEDICAL PROJECT COORDINATOR

<p style="text-align:left"><b>Work Schedule</b></p>Standard (Mon-Fri)<p style="text-align:inherit"></p><p style="text-align:left"><b>Environmental Conditions</b></p>Office<p style="text-align:inherit"></p><p style="text-align:left"><b><u>Job Description</u></b></p><p style="text-align:inherit"></p>Join us as Medical Project Coordinator – And utilize your expertise to support and enhance drug safety operations, ensuring compliance with regulatory standards and optimal patient safety in clinical trials.<br/><br/>What You’ll Do:<br/>• Coordinate and review safety data, utilizing line listings, company dashboard(s) and/or other visualization tools. Review data for safety trends, <br/>coding consistencies, and potential follow up with investigator sites. Identify potential issues and resolve or escalate as appropriate. <br/>• Review safety data and may provide summations for safety review meetings. <br/>• May review designated sections of aggregate reports. <br/>• 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. <br/>• May help manage routine project implementation, forecasting and coordination, including review of metrics and budget considerations. <br/>• Monitor the status of the data review and escalate any delays and/or risks to all stakeholders, including study leads. <br/>• May present at business development, client, and investigator meetings and participate in strategy/business development calls.<br/>• Resolve complex problems through in-depth evaluation of various factors and offers solutions. <br/>• May serve as the primary point of contact for clinical/data management project teams. <br/>• May assist management in training and mentoring. <br/><br/>Education and Experience: <br/>• Bachelor’s degree in nursing or related Health Sciences (Physician's Assistant) or licensed RN <br/>• Previous experience to provide the knowledge, skills, and abilities to perform the job (comparable to 2+ years), to include 2+ years clinical safety experience (clinical research monitoring, or pharmacovigilance or combination of clinical research monitoring and pharmacovigilance) <br/><br/>In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. <br/><br/>Knowledge, Skills and Abilities: <br/>• Knowledge of GCPs for medical oversight of clinical trials and SAE processing <br/>• Knowledge of drug development and safety reporting <br/>• Knowledge of safety data trending to include coding<br/>• Working knowledge of biostatistics, data management and clinical procedures <br/>• Strong problem solving and critical thinking skills<br/>• Good oral and written communication skills <br/>• Good attention to detail <br/>• Ability to work in a collaborative team environment<br/>• Ability to maintain a positive and professional demeanor in challenging circumstances <br/><br/>Working Conditions and Environment: <br/>• Work is performed in an office/ laboratory and/or a clinical environment. <br/>• Exposure to biological fluids with potential exposure to infectious organisms. <br/>• Exposure to electrical office equipment. <br/>• Personal protective equipment required such as protective eyewear, garments and gloves.<br/><br/>Physical Requirements: <br/>• Ability to work in an upright and /or stationary position for 6-8 hours per day. <br/>• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. <br/>• Frequent mobility required. <br/>• Occasional crouching, stooping, with frequent bending and twisting of upper body and neck. <br/>• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. <br/>• Ability to access and use a variety of computer software developed both in-house and off-the-shelf. <br/>• Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. <br/>• Frequently interacts with others to obtain or relate information to diverse groups. <br/>• Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multitask. <br/>• Regular and consistent attendance.<br/><br/>Why Join Us?<br/>When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience – and where your contributions truly make a difference.<br/><br/>Apply today to help us deliver tomorrow’s breakthrough. <br/><p></p><p></p><p></p><p></p>