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Clinical Documentation Specialist

Kelly Services

Lakewood, CO
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Job Details

Job Title Clinical Documentation Specialist

Jobid US15TPCS_BH1431072

Location: Lakewood, CO, 80232, USA

Description **Clinical Evaluation Reporting Specialist- 90-99K per year plus bonus (Direct Hire Position)**

**You must have experience with Clincial Evaluation Reports**

The Clinical Evaluation Specialist relies on product labeling, preclinical data, clinical data, published literature, risk management documentation, complaints, post market surveillance, and adverse event reporting to create the CERs. A number of personnel from different departments will contribute documentation necessary for completion of a CER. The Specialist brings these individuals together and directs them regarding the information needed for CERs. The Specialist will be responsible for data collection, data appraisal, data extraction from the available safety and performance data set. The Specialist will be responsible for the final compilation/authoring of Systematic Literature Reviews (SLRs), CER assessments, new CERs and scheduled CER updates.


• Lead the development of CERs by bringing together various stakeholders (eg, Clinical Safety, Quality Assurance, Regulatory Affairs, Clinical Affairs, Clinical Research Scientists, Pre-clinical Research Scientists, Marketing, Product Lifecycle Engineers, and information specialists [eg Terumo BCT librarians]) to identify relevant documentation needed for the SLR and to import into the content of CERs.

• Collaborate with the information specialist to conduct systematic literature searches on company products and product families, and identified equivalent,comparator and competitor products

• Review and Appraise the published literature to identify articles applicable to the safety and performance of company products.

• Cross-lane collaboration to 1) understand regulatory submissions and priorities, 2) develop literature search stragety with design teams 3) Facilitate the SLR and produce the SLR report 4) compile necessary CER inputs (eg FMEA, RMR, HHA, PMSR, PRR, verfication reports, validation reports) 2) compile and analyze product complaints for both equipment and disposables, 3) conduct Adverse Event Reporting and Recall searches on Terumo products and product families and identified equivalent and comparator products, and 4) compile preclinical data, including verification summary report and validation summary report 5) complie clinical data, including Clinical Investigation Protocols and Clinical Study Reports, for Clinical Investigations

• Author the first draft of SLRs, CER assessments, new CERs and scheduled CER updates for Terumo BCT products, according to business and research priorities

• Manage SLR and CER document reviews, reconcile major review comments and concerns, and manage finalization and approval of the CER

• Collaborate with Clinical Research Scientist and Lead Pre-clinical Scientist on relevant cross-functional teams to provide input on risk management deliverables, clinical research and literature evidence for product development process needs


• Remain current in Clinical Evaluation Report regulatory requirements for all applicable countries

• Develop policies/procedures related to Clinical Evaluation Reviews and Reporting, as needed

• Assist with training contractor(s) on Clinical Evaluation Report development, as needed

• Work with contractor(s) to guide development and update of Clinical Evaluation Reports, as needed

• Dissemate findings quantified in the update process of Clinical Evaluation Reports

• Develops Systematic LIterative Review logistics such as deliverables, timelines and draft reviews

• Develops Clinical Evaluation Report logistics such as deliverables, timelines and draft reviews

• This position is required to assure compliance of Company operations to all applicable laws, regulations, and standards, good business practices and company documented procedures

Qualified individuals must have 5 yrs experience and should possess knowledge of the following: research methodology; information management; experience with relevant databases such as PubMed; regulatory requirements; medical writing; training and experience in medical writing; systematic review; and clinical data appraisal.

• Clinical evaluation reporting experience in academic or the medical device/pharmaceutical industry in clinical, or regulatory roles, or device development experience in medical device/pharmaceutical industry

• The CER Specialist has experience and understanding of clinical research and regulatory guidelines

**Why Kelly** **®** **?**

With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevantprojects. Our connections can lead you to innovative scientific pursuits you’ll be proud to helpadvance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the worlda better place. Let Kelly fuel your career—connect with us today.

**AboutKelly Services** **®**

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit and connectwith us on Facebook , LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and iscommitted to employing a diverse workforce. Equal Employment Opportunityis The Law.

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