Jobs · Healthcare · Tennessee

Study Start Up Operations Manager - Full Time - Wolf River - Registered Nurse (RN)/ Licensed Practical Nurse (LPN) Experience Required

The West Clinic · Germantown, TN · 3 wk ago
HealthcareFull-time

About the role

At West Cancer Center, we are committed to advancing innovative cancer research while delivering compassionate, patient-centered care. Our research teams play a critical role in expanding treatment opportunities and improving outcomes for patients through cutting-edge clinical trials and collaborative research initiatives.

Key Responsibilities

  • Directly supervises Study Start-Up Specialists and other assigned research start-up personnel
  • Provides leadership, mentorship, training, and performance management for study start-up staff
  • Develops departmental workflows, SOPs, and best practices related to study activation and feasibility processes
  • Serves as escalation point for sponsors, CROs, investigators, and internal departments regarding study start-up issues or delays
  • Collaborates with Research Leadership to establish departmental goals, activation metrics, and operational priorities
  • Participates in strategic planning for research growth and study portfolio development
  • Oversees all study start-up activities from initial feasibility through site activation and handoff to study conduct teams
  • Reviews and assigns feasibility requests and ensures timely completion of sponsor-required questionnaires
  • Oversees Confidential Disclosure Agreements (CDAs), protocol review workflows, and study routing processes
  • Coordinates Research Steering Committee (RSC) and Disease Research Group (DRG) review processes
  • Maintains oversight of sponsor communications and manages sponsor expectations throughout the start-up process
  • Oversees maintenance of staff training records, GCP documentation, and protocol-specific training documentation
  • Collaborates with contracts/budget and regulatory teams to support timely study activation
  • Maintains professionalism, confidentiality, and ethical standards in all interactions

Qualifications

  • Education & Experience
    • Minimum of two (2) years of clinical research experience required
    • Strong knowledge of FDA regulations, ICH-GCP guidelines, and clinical trial start-up processes
    • Experience with feasibility assessments, sponsor communications, and study activation workflows
    • Excellent organizational, analytical, and problem-solving skills
    • Ability to manage multiple projects and priorities in a fast-paced environment
    • Strong verbal and written communication skills
    • Proficient in Microsoft Office applications including Excel, Word, Outlook, and Adobe Acrobat
  • Credential/Licensure
    • Current RN/LPN license required

Work Environment & Physical Demands

Typical clinical and office environment with moderate noise level. Ability to sit, stand, walk, reach, bend, and use hands/wrists for extended periods of time. Ability to effectively communicate verbally and in writing. Ability to lift up to 25 pounds. Occasional travel for investigator meetings, sponsor visits, or conferences may be required.

Why West Cancer Center is a Great Place to Work

  • Mission-Driven Environment: Be part of an organization guided by compassion, integrity, and innovation.
  • Professional Development: Benefit from ongoing training, educational resources, and growth opportunities.
  • Multidisciplinary Team: Work alongside a multidisciplinary team of dedicated professionals committed to improving cancer care.
  • Meaningful Impact: Play a direct role in supporting patients through one of the most challenging times of their lives.

Pay

No nights, weekends, or holidays. Comprehensive benefits package.

Schedule

No nights, weekends, or holidays.

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