Clinical Research Spec - Exempt

LanceSoft Inc

Mounds View, MN

JOB DETAILS
JOB TYPE
Full-time
SKILLS
Biology, Budgeting, Clinical Assessment, Clinical Outcomes, Clinical Research, Clinical Trial, Data Management, Drug Development, Electronic Data Capture (EDC), GCP (Good Clinical Practices), Medical Products, Medical Records, Mentoring, Microsoft Office, Oracle, Project/Program Management, Rapid Application Development (RAD), Regulations, Standard Operating Procedures (SOP), Team Player, Vendor/Supplier Selection, Writing Skills
LOCATION
Mounds View, MN
POSTED
30+ days ago
Join our dynamic team in Mounds View, MN, where innovation meets excellence in clinical research. We are seeking a highly motivated individual to oversee, design, and develop clinical evaluation research studies. This role offers the opportunity to work full-time on-site in a collaborative and cutting-edge environment. 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 3 Candidate Experience Requirements Site management experience (site or sponsor) Knowledge/experience with CTMS/EDC/TMF Experience with Good Clinical Practice (GCP) Education and Experience Education Required: Bachelor’s Degree (preferably in engineering, life sciences, or related medical/scientific field) Years of Experience Required: Minimum 2 years of experience Responsibilities Responsibilities may include the following and other duties may be assigned: Oversee, design, plan, and develop clinical evaluation research studies. Prepare and author protocols and patient record forms. Conduct registered and nonregistered clinical studies of products that satisfy a medical need and/or offer commercial potential. Oversee and interpret results of clinical investigations in preparation for new drug device or consumer applications. Oversee and resolve operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP), and specific country regulations. May prepare clinical trial budgets and be responsible for clinical supply operations, site, and vendor selection. Career Stream This position typically involves responsibilities in a professional discipline or specialty. The role requires delivering and/or managing projects assigned and collaborating with other stakeholders to achieve desired results. You may act as a mentor to colleagues or direct the work of other lower-level professionals. Required Knowledge and Experience The position requires practical knowledge and demonstrated competence within the job area, typically obtained through advanced education combined with experience. A University Degree and a minimum of 2 years of relevant experience are required, or an advanced degree with 0 years of experience.

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/