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.
