Medical Project Coord

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.
• Perform