Medical Project Coord

Thermo Fisher Scientific

4d•Onsite

About The Position

The Medical Project Coordinator supports and enhances drug safety operations, helping ensure compliance with regulatory standards and patient safety in clinical trials. The role coordinates and reviews safety data, identifies trends and potential issues, and works with study teams and stakeholders to resolve or escalate concerns. It may also contribute to safety review meetings, aggregate reports, study plans, project implementation, forecasting, and coordination. The position may serve as a primary contact for clinical or data management project teams and may assist with training and mentoring. Work is performed in an office, laboratory, and/or clinical environment. The role may involve exposure to biological fluids and potentially infectious organisms, as well as electrical office equipment. Personal protective equipment such as protective eyewear, garments, and gloves is required. The work schedule is standard Monday through Friday.

Requirements

Bachelor’s degree in nursing or a related health science field (such as Physician Assistant), or licensed RN.
Previous experience providing the knowledge, skills, and abilities to perform the job, comparable to 2 or more years, including 2 or more years of clinical safety experience in clinical research monitoring, pharmacovigilance, or a combination of both.
Knowledge of GCPs for medical oversight of clinical trials and SAE processing.
Knowledge of drug development and safety reporting.
Knowledge of safety data trending, including 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.
Ability to work upright and/or stationary for 6–8 hours per day.
Ability to perform repetitive hand movements and frequent mobility; occasional crouching and stooping, and frequent bending and twisting of the upper body and neck.
Ability to lift and carry objects, including luggage and a laptop computer, up to 15–20 pounds.
Ability to use a variety of in-house and off-the-shelf computer software.
Ability to communicate and understand information presented verbally and in writing, and to interact frequently with diverse groups.
Ability to perform variable tasks under changing and unpredictable conditions, work under stress, and multitask.
Regular and consistent attendance.

Nice To Haves

An equivalent combination of appropriate education, training, and/or directly related experience may be considered sufficient to meet the role requirements.

Responsibilities

Coordinate and review safety data using line listings, company dashboards, 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 them as appropriate.
Review safety data and may provide summaries for safety review meetings.
May review designated sections of aggregate reports.
May help create or review study safety and medical management plans and ensure plan processes reflect the contract and requested services.
May help manage routine project implementation, forecasting, and coordination, including review of metrics and budget considerations.
Monitor data-review status and escalate delays or risks to stakeholders, including study leads.
May present at business development, client, and investigator meetings and participate in strategy or business development calls.
Resolve complex problems through in-depth evaluation of various factors and offer solutions.
May serve as the primary point of contact for clinical or data management project teams.
May assist management with training and mentoring.