Project Coordinator

Now hiring for positions in our U.S. clinical operations headquarters in Nashville, Tennessee

Medelis is a full service oncology Clinical Research Company. We provide sponsors with a highly-skilled and proactive oncology clinical trial management team to design and manage phase I through phase III oncology trials in North America and Europe.

We are looking for an experienced Project Coordinator to assist multiple Project Managers in a fast-paced oncology research environment. Successful applicants must be organized, motivated, quick learner with good communication skills.

Responsibilities For Project Coordinator

• Ensure proper conduct of daily activities in compliance with applicable protocols, FDA regulations, ICH/GCP guidelines, appropriate company and/or client SOPs, and professional standards.
• Provide support to Project Directors and Project Managers and to the clinical monitoring teams for day-to-day study conduct
• Keep Project Directors and Project Managers informed of all study-related issues.
• Ensure investigational research sites have adequate study supplies and project-related tools.
• Assist with developing, assembling, and shipping study-related binders and/or manuals to investigational sites.
• Prepare and submit study and site level documents to central IRBs and assist with local IRB submissions when requested.
• Collection and review of initial and ongoing regulatory documentation for submission to appropriate Medelis or client regulatory representatives.
• Develop and/or maintain project tracking spreadsheets to document study activities
• Create Regulatory Document Management Plan for each study and assist in creating/reviewing other study plans as requested.
• Participate in or lead project-specific teleconferences or face-to-face meetings.
• Participate in or lead protocol-specific training and other developmental activities.
• Participate in business development activities.
• Create agendas and/or write minutes for project meetings.
• Maintain study documents in the Trial Master File (TMF)
• Establish good working relationships with client project teams, site staff, and vendors to ensure client satisfaction.

Requirements For Project Coordinator To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

• Fluent in English (both written and verbal).
• Good computer skills (Microsoft Word, Excel, Outlook, etc.).
• Basic knowledge of drug development, the project management process, FDA regulations, and ICH/GCP guidelines.
• Ability to work with investigative sites and Medelis clients by proactively assessing their needs, negotiating effectively, and liaising in a professional manner.
• Experience in handling multiple, high-priority tasks simultaneously.
• Excellent organizational and communication skills.

EDUCATION And/or EXPERIENCE The above qualifications may be gained through completion of a Bachelor’s Degree (preferable in health science) and a minimum of two years of experience in the clinical research industry (including demonstrated competency in clinical project tasks), or through completion of five years of experience without a degree (including demonstrated competency in clinical project tasks).

Travel Requirements

• Must be available for domestic/international travel including overnight stays.
• Must have the ability to safely operate an automobile and have a valid driver’s license.