As an Entry-Level Project Coordinator, you will have the opportunity to work within our Clinical Trial Management group, supporting our many projects and gaining some vital experience. You will be a productive member of the team, and will be mentored and supported as you develop your skills. Working directly with the clinical trial management team, you will gain valuable hands on experience to enable you to develop a career in clinical research.

Responsibilities

• Responsible for routine departmental support including maintaining supplies, shipping, archiving, filing, faxing, scheduling meetings, and providing minutes
• Maintain departmental databases and electronic clinical trial registries
• Obtain certifications for official study documents

Qualifications

• Bachelor's Degree in a health science field
• Excellent computer, organizational, and communication skills

Clinical Data Coordinator

Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based Clinical Data Coordinator to join our Data Management team. This position will work on a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you.

Responsibilities

• Track case report forms
• Clean the clinical database, which includes generating and resolving data clarifications
• Update the clinical database
• Reconcile clinical data
• Maintain study documentation
• Perform QC audits of the clinical database

Qualifications

• Bachelor's degree in a health related field with strong attention to detail and working knowledge of Excel and Word
• 1-2 years of experience in a pharmaceutical or CRO setting preferred

Regulatory Submissions Coordinator

Our clinical activities are growing rapidly, and we are currently seeking a full-time, office-based Regulatory Submissions Coordinator to join our Clinical Operations team. This position will work on a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you.

Responsibilities

• Communicate with research sites regarding the distribution and review of site essential documentation
• Maintain and perform quality review of Trial Master File (TMF)
• Collect, review, organize, and assemble regulatory start-up submissions
• Maintain timelines for site start-up
• Provide advice and guidance to internal and external team members to ensure compliance with applicable regulations and requirements
• Review pertinent regulations and guidance to develop proactive solutions to regulatory submissions issues and challenges

Qualifications

• A minimum of a Bachelor's degree is required (preferably in a Life Sciences field)
• Some experience in an office setting is preferred
• Excellent organizational and prioritization skills
• Knowledge of Microsoft Office
• Great attention to detail and excellent oral and written communication skills

• May lead proposal planning meetings to:
• Identify issues and client requirements
• Recommend proposal and overall study strategies, based on experience
• Encourage multi-disciplinary discussions among subject matter experts to facilitate full and high-quality contributions to the text
• Establish timelines and deliverables and hold internal stakeholders accountable to those plans and timelines

• Review and analyze Request for Information (RFI) and/or Request for Proposal (RFP) documents to gain understanding of client requirements and assist in identifying missing information.
• Identify information to be addressed in proposal text
• Collate follow-up questions for additional information as requested
• Draft standard documents in accordance with agreed strategy and Sponsor requirements within often expedited timelines
• Contribute to assigned process improvement initiatives and support implementation
• Define action plans and timelines; manage and determine modifications needed to ensure proposal alignment with client requirements and business strategies
• Perform quality control/peer review and participate in the finalization of documents and distribution to the customer and internal departments

• Bachelor’s degree required
• Strong initiative to learn
• Strong written and oral communication skills
• Project management skills and the ability to prioritize multiple projects and tasks

• Coordinate feasibility assessments and deliver high quality, accurate feasibility data to internal and external teams;
• Develop preliminary proposal strategy for site and country selection;
• Perform outreach to investigative sites to obtain indication and protocol specific feedback;
• Present feasibility results to members of the proposal team to assure correct assumptions were applied and strategy is in line with our therapeutic and operational experience;
• Create study-specific feasibility questionnaires, cover letters, and other feasibility-related documents;
• Assist project teams with preparation for bid defense meetings; and
• Support departmental process improvement initiatives and general departmental administrative functions.

• Bachelors degree in life sciences required, Masters or PhD preferred;
• Analytical thinker with great attention to detail;
• Ability to prioritize multiple projects and tasks within tight timelines;
• Working knowledge of feasibility processes; and
• Excellent written and verbal communication skills.

• Cincinnati Campus Overview
• Hybrid work-from-home options (dependent upon position and level)
• Competitive PTO packages, starting at 20+ days
• Flexible work hours
• Discounted tuition for UC online programs
• Company-sponsored employee appreciation events
• Employee health and wellness initiatives
• Community involvement with local nonprofit organizations
• Competitive compensation and benefits package
• Structured career paths with opportunities for professional growth
• Partnership and discount with onsite childcare
• Discounted tuition for UC online programs
• Discounts on local sports games, local fitness gyms and attractions
  • Official Sponsor of FC Cincinnati
• Modern, ecofriendly campus with an on-site fitness center, bar, and restaurants

• Recognized by Forbes as one of America's Best Mid-size Companies in 2021 and 2022
• Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility