Highlights
Resolve operational aspects of clinical trials in conjunction with project teams, adhering to SOPs, GCP, and specific country regulations. Advanced knowledge of clinical trial management systems (CTMS), electronic data capture (EDC), and trial master file (TMF).
Numbers & Facts
| Location | Virtual, MN |
| Industry | Staffing/Employment Agencies |
| Salary | $50 |
| Company Size | 2,000 to 2,499 employees |
| Year Founded | 2000 |
| Website | http://www.lancesoft.com/ |
Description
Join our team as a Senior Clinical Research Specialist and be at the forefront of driving clinical trial timelines and innovations. This role offers the unique opportunity to work remotely from Virtual, MN, providing flexibility and work-life balance while contributing to groundbreaking clinical research.
Key Responsibilities
- Oversee, design, plan, and develop clinical evaluation research studies.
- Prepare and author protocols and patient record forms.
- Conduct registered and non-registered clinical studies of products that meet medical needs or offer commercial potential.
- Oversee and interpret results of clinical investigations for new drug, device, or consumer applications.
- Resolve operational aspects of clinical trials in conjunction with project teams, adhering to SOPs, GCP, and specific country regulations.
- Prepare clinical trial budgets and may be responsible for clinical supply operations, site, and vendor selection.
- Bachelor's degree required.
- Minimum of 4 years of relevant experience, or an advanced degree with a minimum of 2 years of relevant experience.
- Advanced knowledge of clinical trial management systems (CTMS), electronic data capture (EDC), and trial master file (TMF).
- Experience with Good Clinical Practice (GCP).
- Preferred: Knowledge of diabetes therapy and audit experience.
- Autonomy: Work independently under limited supervision, developing approaches to solutions.
- Organizational Impact: Responsible for entire projects or processes, contributing to work group objectives.
- Innovation and Complexity: Address complex problems requiring an understanding of multiple issues and specialties.
- Communication and Influence: Communicate effectively with senior internal and external customers and vendors.
- Leadership and Talent Management: Provide guidance, coaching, and training to other employees within the job area.
This is an exciting opportunity to be part of a dynamic team, driving innovation and excellence in clinical research. Apply today and make a significant impact on the future of healthcare.
About Company
We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc).
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.
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