CLINICAL SAFETY ASSOCIATE
Warsaw, IN 46582
Fladger and Associates, Inc
Duties and Responsibilities
· This individual will be responsible for the adverse/safety event review process within Orthopaedics, as well as fostering strong, productive relationships with colleagues within the Organization.
· Process, review, manual medical coding, follow up and reporting of safety events as part of the safety management within Investigator Initiated Studies and Clinical Registries (DOTS).
· Under general supervision, accountable for the timely tracking and ensuring complete safety reporting for assigned Investigator initiated studies and DOTS registries according to appropriate regulations, departmental guidelines, and work instructions.
· Coordinates with internal Operating Company Quality and Safety Officers/Medical monitors on all applicable safety issues.
· Track and ensure complete adverse event reporting for all assigned investigator initiated studies and DOTS registries.
· Report and track the final disposition of all applicable adverse events to appropriate departments within the required timeframes.
· Track and ensure safety reporting, including any serious or unanticipated adverse event reports submitted to regulatory agencies are also submitted to applicable site review boards (IRBs/ECs).
| Summary of Qualifications || · Bachelor of Science Degree in medical profession required.|
· Typically requires BS with at least 3-5 years of relevant experience, Masters with 1-3 years or PhD/MD/PharmD with 0-2 years of relevant experience.
· Requires experience in a clinical setting, particularly with medical records, and terminology.
· Incumbent knows, understands, incorporates, and complies with all applicable laws and regulations relating to business activities and Policies and Procedures of the Health Care Compliance Program and Code of Conduct.
· Clinical Research Experience preferred.
· Some understanding and application of regulations and standards applied in clinical areas and medical devices/combination products.
· Some knowledge of adverse events associated with orthopaedics is preferred.
| Desired Education: || Bachelor's Degree
|Relevant Experience:|| Scientific Research |
| Overnight Travel:|| 1-10% |
| U.S. Work Eligibility:|| H1-Work Visa Holder |
Permanent Resident / Green Card Holder
Student Visa Holder
Compensation Related Information
| Compensation: || $1,111.00 - $1,111.00
| Pay Composition: || Base Pay |
| Benefits:|| |
General Job Information
| Company: || Fladger and Associates, Inc |
| Company Profile: || Fladger Associates is a professional, national executive search and human capital solutions firm specializing in licensed, degreed, or certified professionals in: |
. Pharmaceutical Clinical Research
. Information Technology/Engineering
. Medical Technology
Our Passion - Building Long Term Client Partnerships that satisfy your requirements for the very best Human Resources while providing career development opportunities for our candidates.
Fladger Associates excels at identifying highly qualified professionals to whom our clients might not otherwise have access.
You will find that we operate differently than most firms in the industry, we care about matching the clients and candidates, to ensure that requirements and cultures match.
How We Work
We leverage a vast network of relationships, specialized industry knowledge, state of the art research, and proprietary management software to provide the comprehensive coast-to-coast coverage needed to find highly qualified topnotch candidates for client requirements.
| Job Title: || Clinical Safety Associate |
| Job Number: || 28632978 |
| Location: || Warsaw, IN
United States 46582 |
| Posting Date: || 06/16/2012 |
| Job Type: || Direct Hire -- Full Time
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