Medical Project Coordinator

Description

Summary: Join as a Medical Project Coordinator to support drug safety operations, ensuring regulatory compliance and optimal patient safety in clinical trials. Highlights: 1. Coordinate and review safety data for trends and consistency 2. Resolve complex problems through in-depth evaluation 3. Work in a collaborative team environment **Work Schedule** Standard (Mon\-Fri)**Environmental Conditions** Office**Job Description** 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. **What You’ll Do:** * 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 the 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. **Education and Experience:** * Bachelor’s degree in nursing or related Health Sciences (Physician's Assistant) or licensed RN * 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) 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. **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 * Good attention to detail * Ability to work in a collaborative team environment * Ability to maintain a positive and professional demeanor in challenging circumstances **Working Conditions and Environment:** * Work is performed in an office/ laboratory and/or a clinical environment. * Exposure to biological fluids with potential exposure to infectious organisms. * Exposure to electrical office equipment. * Personal protective equipment required such as protective eyewear, garments and gloves. **Physical Requirements:** * Ability to work in an upright and /or stationary position for 6\-8 hours per day. * Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. * Frequent mobility required. * Occasional crouching, stooping, with frequent bending and twisting of upper body and neck. * Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15\-20 lbs. * Ability to access and use a variety of computer software developed both in\-house and off\-the\-shelf. * 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. * Frequently interacts with others to obtain or relate information to diverse groups. * 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. * Regular and consistent attendance. **Why Join Us?** 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. Apply today to help us deliver tomorrow’s breakthrough.