Clinical Affairs Specialist – FILLED
The Wellington Group has been engaged to find an experienced Clinical Affairs Specialist with a strong medical device / device trials or pharmaceutical trials operational background. This is a great opportunity to work for one of the industries leading medical device companies with a focus on current and future technologies.
The Clinical Affairs Specialist is responsible for ensuring that clinical research compliance is maintained for clinical trials in domestic and international countries.
- Monitor assigned clinical investigational sites which includes source document verification, device inventory records review and physical count, case report form review, verification of appropriate informed consent and adverse event reporting. Monitoring visits will be summarized in a written report.
- Maintain monitoring plans for assigned studies.
- Assure positive relationship with investigational sites by: Training site personnel on protocol requirements, electronic data entry process, source documentation requirements and good clinical practices, Timely reimbursement payments, Assist with contract implementation, Assist with IRB submissions, Assure adequate supplies
- Data Management activities include: Data entry as needed, Review site-entered data on e-forms software, Create/Issue/Resolve data queries and non-compliances, Maintain site files, Review Adverse Effects
- Clinical progress report writing and other reports as needed.
- Study monitoring to assure data completeness and compliance with domestic and international requirements.
- Study close-out visits at sites and preparation for FDA inspections.
The qualified candidate will have:
- Bachelor’s Degree in Clinical/Science Health Science, Business, Nursing, or related field a plus
- Thorough knowledge of Good Clinical Practices
- Ability to travel required up to 40%.
- Two to three years experience in device or pharmaceutical clinical trials; or combination of education and experience
- Certified Clinical Research from ACRP or SOCRA certification preferred
- Knowledge of domestic/international medical device regulations, required
- Must have strong communication skills both written and verbal
Industry: Medical Device, Biotechnology, Combination Products, Clinical Research
Don’t wait, apply with The Wellington Group today!
(all information will be held in the strictest of confidence)