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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in coordinating clinical study set-up activities, ensuring compliance with quality systems, and managing project timelines and budgets. Proficient in regulatory documentation preparation and stakeholder communication, with a strong focus on detail and problem-solving.
Highest-signal resume keywords
Project CoordinationClinical ResearchRegulatory DocumentationMicrosoft Office ProficiencyStudy Start-Up Experience
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Project ManagementClinical ResearchStudy Start-UpData ProgrammingAnalytical PlanningDocumentation ManagementRisk IdentificationBudget ManagementTimeline ManagementMultitasking
Soft Skills
Professional CommunicationOrganizational SkillsCritical ThinkingProblem-SolvingCustomer Service Orientation
Tools & Technologies
Microsoft WordMicrosoft ExcelMicrosoft PowerPointMicrosoft Power BI
Industry Keywords
BiologyBiochemistryBiomedical SciencesPharmaceutical SciencesClinical LaboratoriesGCPCAPCLIAHistopathologyGenomics
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Coordinate clinical study set-up activities from project award through study initiation and operational readiness
- Ensure projects are delivered within agreed scope, timeline, and budget and comply with CellCarta’s Quality System
- Work alongside experienced Project Managers and cross-functional teams, gradually assuming increasing responsibilities
- Initiate study set-up and engage Business Development colleagues and/or clients
- Draft and develop analytical plans in collaboration with clients and internal teams
- Gather study requirements and translate them into set-up activities, timelines, documentation, and deliverables
- Coordinate with internal stakeholders to prepare Operations for study testing
- Initiate database builds when required and ensure timely commencement
- Support preparation and submission of regulatory documentation to ethics committees and regulatory authorities
- Coordinate and host client kick-off meetings
- Manage scope changes during contracting and study set-up
- Maintain comprehensive study documentation, centralized project communications, and detailed meeting minutes
- Identify and escalate risks, issues, dependencies, and roadblocks
- Provide clear study set-up updates to internal and external stakeholders
- Coordinate an organized handoff to the Conduct Project Manager upon completion of set-up
Requirements
What you’ll need- Bachelor’s degree in Biology, Biochemistry, Biomedical Sciences, Pharmaceutical Sciences, or Medicine
- 1 to 2 years of project coordination, project management, clinical research, laboratory, or related project support experience
- Study Start-up experience is a plus
- Proven success in managing complex projects to completion, with positive feedback and the ability to balance multiple priorities effectively
- Professional-level communication skills; proficient in English, both written and verbal
- Proficient in Microsoft Office (Word, Excel, PowerPoint, Power BI)
- Excellent organizational skills with the ability to multitask
- Self-motivated, adaptable, and able to thrive in a dynamic environment
- Diligent with strong attention to detail
- Capable of working both independently and collaboratively
- Strong critical thinking and problem-solving abilities
- Customer- and project service-oriented mindset
- A solution-driven attitude with persistence and determination
- Preferred: Master’s degree in Biology, Biochemistry, Biomedical Sciences, Pharmaceutical Sciences, or Medicine
- Preferred: Experience in cancer research and clinical laboratories, assay/instrument principles, and clinical research scientific, statistical, regulatory, and compliance requirements
- Preferred: Experience with Histopathology and/or Genomics services
- Preferred: Experience working in CAP, CLIA, and GCP environments, with working knowledge of EMEA and/or FDA clinical-trial guidelines
- Preferred: Experience with histopathology, anatomic pathology, immunohistochemistry (IHC), genomics, FISH, ISH, or immunofluorescence
- Preferred: Experience in data programming and validation
- Preferred: Experience working in global settings
- Must be legally authorized to work in the U.S.
- Must be able to work Monday-Friday, 8:00 a.m.-5:00 p.m., with flexibility
Benefits
Comp & perks- Medical, dental, and vision benefits
- Telemedicine service and Employee Assistance Program (EAP)
- Vacation and sick time
- 401(k) Retirement Savings Plan with employer matching
- Employee Annual Incentive Plan (EAIP)
- Career development opportunities
- Certifications Support Program
- Life insurance
- Short-term and long-term disability
- Hybrid flexibility to work from home, starting with approximately 1-2 days per week and gradually increasing following the training period
- Flexible Monday-Friday schedule, 8:00 a.m.-5:00 p.m.
