Assoc Clinical Research Spec - Exempt

LanceSoft Inc

Saint Paul, MN

JOB DETAILS
JOB TYPE
Full-time
SKILLS
Adverse Events, Clinical Monitoring, Clinical Research, Clinical Trial, Drug Development, Maintain Compliance, Medical Writing, Medicine, Nursing, Pharmacovigilance, Regulations, Safety Compliance, Time Management
LOCATION
Saint Paul, MN
POSTED
30+ days ago
Join our team as a Clinical Safety Specialist and play a crucial role in ensuring compliance with clinical study safety and potential complaint data reporting. This position offers the flexibility of working remotely from Virtual, MN, or close proximity to our MDT offices in Minneapolis or Santa Rosa. Key Responsibilities Review and assess clinical study Adverse Events (AEs) including Serious Adverse Events (SAEs) and device deficiencies. Interact with investigational sites and clinical monitors to gather additional pertinent information as indicated in the Clinical Investigation Plan (CIP). Collaborate with Regulatory Affairs and Product Complaint Reporting teams to ensure timely reporting of AEs, SAEs, and Unanticipated Serious Adverse Device Effects (U[S]ADEs). Author Clinical Safety Management and Potential Complaint Plan (CSMPCP) for assigned studies. Assist with preparation of safety reports for annual reports, clinical study reports, and other documents as required. Support study audits for Safety-specific topics and facilitate Clinical Event Committee (CEC) work. Prepare, attend, and/or lead Safety Trending meetings. Qualifications Background in science, nursing, or medicine. Experience with RAVE and VAULT databases. Safety experience is a plus. Bachelor's degree required. 0-5 years of experience in a related field. This position offers the opportunity to work 40 hours a week, with flexibility for remote work. Join us and contribute to the safety and efficacy of our clinical studies.

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/