Clinical Research Spec - Exempt

LanceSoft Inc

Mounds View, MN

JOB DETAILS
SALARY
$40–$45 Per Hour
SKILLS
Biology, Budgeting, Clinical Assessment, Clinical Outcomes, Clinical Research, Clinical Trial, Data Management, Decision Support, Drug Development, Electronic Data Capture (EDC), GCP (Good Clinical Practices), Leadership, Maintain Compliance, Medical Products, Medical Records, Mentoring, Microsoft Office, Oracle, People Management, Problem Solving Skills, Project/Program Management, Rapid Application Development (RAD), Regulations, Standard Operating Procedures (SOP), Talent Management, Vendor/Supplier Selection, Writing Skills
LOCATION
Mounds View, MN
POSTED
30+ days ago

Join our team in Mounds View, MN, a vibrant community offering a great balance of work and lifestyle. We are seeking a dedicated professional to oversee, design, and develop clinical evaluation research studies, ensuring they meet medical needs and commercial potential. This role requires a combination of technical expertise and project management skills to drive clinical studies from conception through implementation.

Must Have:

  • Experience with CTMS and patient data and site management systems (i.e., Veeva Vault, RAD Rave, Oracle)
  • Proficiency in Microsoft Office Applications

Top Needs:

  • Site Management experience (site or sponsor)
  • Knowledge of/experience with CTSM/EDC/TMF
  • Experience with Good Clinical Practice (GCP)
  • Nice to have: Experience with Diabetes

Education and Experience Required:

  • Bachelor's Degree (preferably in life sciences or medical/scientific field)
  • Minimum 2 years of relevant experience with a Bachelor's degree or 0 years with an advanced degree

Work Schedule:

Full-time, 40 hours a week on-site as per the mandate.

Responsibilities:

  • Prepare and author protocols and patient record forms.
  • Conduct registered and nonregistered clinical studies of products.
  • 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.
  • Ensure compliance with SOP, GCP, and specific country regulations.
  • May prepare clinical trial budgets and be responsible for clinical supply operations, site, and vendor selection.

Specialist Career Stream:

This role is for an individual contributor with responsibility in a professional discipline or specialty. You will deliver and manage projects assigned, working with other stakeholders to achieve desired results. You may also act as a mentor to colleagues or direct the work of other lower-level professionals.

Differentiating Factors:

  • Autonomy: Work independently with general supervision on larger, moderately complex projects/assignments.
  • Organizational Impact: Set objectives for your own job area to meet project and assignment objectives.
  • Innovation and Complexity: Address general problems and issues, making adjustments or recommending enhancements to improve effectiveness.
  • Communication and Influence: Communicate primarily with internal contacts to share information, gain input, and support decision-making.
  • Leadership and Talent Management: May provide guidance and assistance to entry-level professionals.

About the Company

L

LanceSoft Inc

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.

COMPANY SIZE
2,000 to 2,499 employees
INDUSTRY
Staffing/Employment Agencies
FOUNDED
2000
WEBSITE
http://www.lancesoft.com/