Medical Project Coordinator

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 escalale 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 escalale 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