Medical Project Coordinator

Job description

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.