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 Youll 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:
Bachelors degree in nursing or related Health Sciences (Physicians 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. Youll 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 tomorrows breakthrough.