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		<title> Jobs at Laguna-Source    </title>
		<link>http://www.jobvolume.com/rss/jobs-q-company%3A%22Laguna-Source%22.xml</link>
		<description> Jobs at Laguna-Source    </description>
		<language>en-us</language>
		<copyright>Copyright (c) 2006 Jobvolume All rights reserved.</copyright>
		<lastBuildDate>Wed, 3 Dec 2008 06:24:55 GMT</lastBuildDate>

        
                  <item>
                        <title><![CDATA[Clinical Research Associate / CRA - Medical Device at Laguna Source, (USA-CA-Newark)]]></title>
                        <link>http://www.jobvolume.com/jobid.jsp?jkey=853153302</link>
                        <guid isPermaLink="false">853153302</guid>
                        <pubDate>Sun, 30 Nov 2008 18:22:04 GMT</pubDate>
                        <description><![CDATA[Clinical Research Associate / CRA - Medical Device
Clinical Research Associate II (CRA 2) - Medical Device
Newark, CA area (East Bay)
We are a clinical stage ophthalmology medical device company located in the Newark, CA area. We have an immediate need for a full time Clinical Research Associate II (CRA II) to perform clinical site monitoring (pre-study, initiation, monitoring and close-out visits) at investigator sites. This is a full time permanent employee position based in the East Bay and requires up to 50% domestic travel. 
Position Requires:
Extensive clinical site monitoring to ensure CGP compliance according to company SOP.Obtain, review and process administrative and regulatory documents from investigator sites.Prepare reports for clients, project personnel, and management.Review CRFs for completeness and accuracy.Generate and resolve queries of CRF data with study site personnel.Review Tables and Listings.Assist in writing Clinical Study Reports.
Minimum of 2 years of medical device or pharmaceutical INDUSTRY experience as a Clinical Research Associate (CRA).Strong experience in clinical site monitoring.Expertise in data management, quality control and regulatory affairs related to clinical research.Willingness to travel up to 50%.
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Privacy Notice: Weâll save your name, resume, and the email address you&apos;ve entered so that we can contact you about the status of your application if necessary, and for our internal reporting purposes. We will not disclose your e-mail address to anyone other than this employer.
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                  <item>
                        <title><![CDATA[Vice President - Reimbursement - Medical Device at Laguna Source, (USA-CA-San Francisco)]]></title>
                        <link>http://www.jobvolume.com/jobid.jsp?jkey=3665576083</link>
                        <guid isPermaLink="false">3665576083</guid>
                        <pubDate>Sun, 30 Nov 2008 18:21:11 GMT</pubDate>
                        <description><![CDATA[Vice President - Reimbursement - Medical Device
Vice President - Reimbursement - Medical Device
- You can be located anywhere in the US - WORK FROM HOME
Do you have extensive experience with medical device reimbursement coding, payment processes and coverage? If so, please read on...
We are a growing medical device company located in the East Bay. We recently received FDA clearance on our medical device and are currently in the product launch phase. We are seeking a full time VP Reimbursement. In this key position you will interact with outside physicians and payers as well as internal communication between Clinical, Marketing and Sales. You will be responsible for developing the payer strategy and communicate strategy and goals to management teams. You will review and adjust payer targets and gain agreement on priority changes. You will also have overall responsibility for coverage decisions and monitor payer relations efforts and lead reimbursement department. Lastly, you will travel with sales to meetings, tradeshows, etc.
Position Requires:
Bachelors Degree and a minimum of 10 years of medical device reimbursement experience. Strong understanding of medical device reimbursement coding, payment processes and coverage.Expertise in payer coverage decisions and development of coverage policy. Ability to travel up to 30%.
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Privacy Notice: Weâll save your name, resume, and the email address you&apos;ve entered so that we can contact you about the status of your application if necessary, and for our internal reporting purposes. We will not disclose your e-mail address to anyone other than this employer.
]]></description>
                  </item>
                
                  <item>
                        <title><![CDATA[Clinical Research Project Manager - Pharmaceutical at Laguna Source, (USA-CA-Irvine)]]></title>
                        <link>http://www.jobvolume.com/jobid.jsp?jkey=783402060</link>
                        <guid isPermaLink="false">783402060</guid>
                        <pubDate>Sun, 30 Nov 2008 16:24:07 GMT</pubDate>
                        <description><![CDATA[Clinical Research Project Manager - Pharmaceutical
Must have international clinical trial experience!
Established Orange County Biopharmaceutical company has an immediate need for a full time Clinical Research Project Manager. This is an office-based position in Orange County and requires up to 40% domestic and international travel.
You will be responsible for developing a strategic clinical approach for the overall clinical development of a product or device both domestically and internationally. 
Responsibilities Include:
Manage study start-up activities.
Participation in site training.
Protocol design and implementation.
Site management and visits.
Ensure integrity of clinical data.
Ensure adherence to regulatory and company guidelines.
Evaluation of clinical data.
Assist with regulatory filings.
Necessary administrative activities as part of the project team.
Safety reporting.
Assurance of adherence to regulatory guidelines and SOPÃ¢â¬â¢s.
Bachelors Degree (Masters Preferred) with a minimum of 5 years of pharmaceutical industry clinical / regulatory monitoring experience including multi-center clinical studies.
Strong knowledge of ICH, GCPs and other regulations and experience managing at least one multi-center study and other Phase I - III studies using CROs is a must. 
Clinical Research Certification (CRC) a plus.
Must be willing and able to travel both domestic and internationally up to 40% of the time (domestic and international).
: 
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Privacy Notice: Weâll save your name, resume, and the email address you&apos;ve entered so that we can contact you about the status of your application if necessary, and for our internal reporting purposes. We will not disclose your e-mail address to anyone other than this employer.
]]></description>
                  </item>
                
                  <item>
                        <title><![CDATA[Vice President - Reimbursement - Medical Device at Laguna Source, (USA-CA-San Francisco)]]></title>
                        <link>http://www.jobvolume.com/jobid.jsp?jkey=3563811436</link>
                        <guid isPermaLink="false">3563811436</guid>
                        <pubDate>Sun, 30 Nov 2008 16:21:02 GMT</pubDate>
                        <description><![CDATA[Vice President - Reimbursement - Medical Device
Vice President - Reimbursement - Medical Device
- You can be located anywhere in the US - WORK FROM HOME
Do you have extensive experience with medical device reimbursement coding, payment processes and coverage? If so, please read on...
We are a growing medical device company located in the East Bay. We recently received FDA clearance on our medical device and are currently in the product launch phase. We are seeking a full time VP Reimbursement. In this key position you will interact with outside physicians and payers as well as internal communication between Clinical, Marketing and Sales. You will be responsible for developing the payer strategy and communicate strategy and goals to management teams. You will review and adjust payer targets and gain agreement on priority changes. You will also have overall responsibility for coverage decisions and monitor payer relations efforts and lead reimbursement department. Lastly, you will travel with sales to meetings, tradeshows, etc.
Position Requires:
Bachelors Degree and a minimum of 10 years of medical device reimbursement experience. Strong understanding of medical device reimbursement coding, payment processes and coverage.Expertise in payer coverage decisions and development of coverage policy. Ability to travel up to 30%.
]]></description>
                  </item>
                
                  <item>
                        <title><![CDATA[Clinical Research Associate / CRA - Medical Device at Laguna Source, (USA-CA-Newark)]]></title>
                        <link>http://www.jobvolume.com/jobid.jsp?jkey=1208746007</link>
                        <guid isPermaLink="false">1208746007</guid>
                        <pubDate>Sun, 30 Nov 2008 16:19:53 GMT</pubDate>
                        <description><![CDATA[Clinical Research Associate / CRA - Medical Device
Clinical Research Associate II (CRA 2) - Medical Device
Newark, CA area (East Bay)
We are a clinical stage ophthalmology medical device company located in the Newark, CA area. We have an immediate need for a full time Clinical Research Associate II (CRA II) to perform clinical site monitoring (pre-study, initiation, monitoring and close-out visits) at investigator sites. This is a full time permanent employee position based in the East Bay and requires up to 50% domestic travel. 
Position Requires:
Extensive clinical site monitoring to ensure CGP compliance according to company SOP.Obtain, review and process administrative and regulatory documents from investigator sites.Prepare reports for clients, project personnel, and management.Review CRFs for completeness and accuracy.Generate and resolve queries of CRF data with study site personnel.Review Tables and Listings.Assist in writing Clinical Study Reports.
Minimum of 2 years of medical device or pharmaceutical INDUSTRY experience as a Clinical Research Associate (CRA).Strong experience in clinical site monitoring.Expertise in data management, quality control and regulatory affairs related to clinical research.Willingness to travel up to 50%.
]]></description>
                  </item>
                
                  <item>
                        <title><![CDATA[Quality Engineer - Manager - Medical Device at Laguna Source, (USA-CA-Mountain View)]]></title>
                        <link>http://www.jobvolume.com/jobid.jsp?jkey=2762608865</link>
                        <guid isPermaLink="false">2762608865</guid>
                        <pubDate>Sun, 30 Nov 2008 16:19:21 GMT</pubDate>
                        <description><![CDATA[Quality Engineer - Manager - Medical Device
We are an established international Medical Device company with a diverse product line. We have an immediate need for a full time Manager of Quality Engineering. In this key position you will support and sustain procedures required to move medical device products from Performance Development Planning (PDP) process through commercialization. You will also manage Quality Engineers and oversee cross-functional teams (Manufacturing, R D. Regulatory) to ensure Quality Systems compliance to ISO, FDA, QSR&apos;s, cGMP and ensure company timelines are met. 
Position Requires:
Bachelors Degree in Engineering and a minimum of 7 years of progressive quality engineering and quality systems experience within the medical device industry.Strong management level experience.Expertise in PDP, cGMP, ISO, FDA, QSR and International regulatory standards.
: 
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Privacy Notice: Weâll save your name, resume, and the email address you&apos;ve entered so that we can contact you about the status of your application if necessary, and for our internal reporting purposes. We will not disclose your e-mail address to anyone other than this employer.
]]></description>
                  </item>
                
                  <item>
                        <title><![CDATA[Regional Clinical Research Associate Ophthalmology at Laguna Source, (USA-CA-Irvine)]]></title>
                        <link>http://www.jobvolume.com/jobid.jsp?jkey=3074986684</link>
                        <guid isPermaLink="false">3074986684</guid>
                        <pubDate>Sun, 30 Nov 2008 16:16:22 GMT</pubDate>
                        <description><![CDATA[Regional Clinical Research Associate OphthalmologyRegional Clinical Research Associate - CRA - Ophthalmology Medical Device
Nationwide, US - Can be located anywhere in the US 
Are you an experienced Clinical Research Associate with strong therapeutic experience in Ophthalmology medical devices? Are you able to work independently and willing to travel up to 70% of the time? If so, please read on...
We are an growing ophthalmic medical device manufacturer in the San Francisco Bay area. We have an immediate need for a full time Regional Clinical Research Associate. 
You will assist in the design and implementation of clinical projects and be responsible for monitoring activities at various clinical study sites to assure adherence to regulatory guidelines (GCP, ICH), SOPs, and study protocols. You may also participate in study development and start-up process including reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training. 
This is an regional position and requires up to 70% national travel to study sites. You can be based anywhere in the US close to a major airport. 
This position requires a minimum of 4 years of experience as a Clinical Research Associate (CRA) and strong understanding of Medical Device Clinical Research / Clinical Trials regulatory guidelines. You must also have experience in Clinical Site Monitoring. 
Strong experience in Ophthalmology (either Medical Device or Pharmaceutical) is a MUST for this job.
For immediate confidential consideration please send a Word copy of your resume directly to Dan Boersma: Dan\@LagunaSource.com 
Keyterms: Clinical Research Manager, Clinical Research Project Manager, Senior Clinical Research Associate, Sr. CRA, Clinical Research Coordinator, CRC, CCRC, Medical Device, Biopharma, Pharma, Ophthalmology
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Privacy Notice: Weâll save your name, resume, and the email address you&apos;ve entered so that we can contact you about the status of your application if necessary, and for our internal reporting purposes. We will not disclose your e-mail address to anyone other than this employer.
]]></description>
                  </item>
                
                  <item>
                        <title><![CDATA[Clinical Research Project Manager - Medical Device at Laguna Source, (USA-CA-Irvine)]]></title>
                        <link>http://www.jobvolume.com/jobid.jsp?jkey=160228430</link>
                        <guid isPermaLink="false">160228430</guid>
                        <pubDate>Sun, 30 Nov 2008 16:14:18 GMT</pubDate>
                        <description><![CDATA[Clinical Research Project Manager - Medical Device
Clinical Project Manager - Medical Device
South Orange County, CA
We are a growing orthopedic medical device company with a diverse and innovative product line. We have an immediate need for a full time Clinical Project Manager. In this key clinical position, you will report to the VP and be responsible for developing and executing clinical studies and oversight and training of both in-house clinical staff (CRA&apos;s) and off-site CRO&apos;s. You will also write clinical study protocols, CRFs, regulatory binders, study manuals and physician brochures and ensure patient data is collected accurately and per company / regulatory guidelines. You will also participate in clinical site set-up an close out activities and will be required to perform clinical site monitoring / troubleshooting as needed (up to 30% travel).
Position Requires:
Must have a Bachelors Degree and a minimum of 5 years of recent medical device industry clinical research experience. 1 year of Clinical Project Management experience.Previous medical device industry experience as a Clinical Research Associate (CRA). Ability to write clinical protocols and other clinical writing expertise.Strong knowledge of regulatory guidelines and quality assurance related to clinical research studies.
This is a full time in-house position based in Orange County, CA and requires up to 30% travel (some overnights will be required). 
For immediate confidential consideration please email a Word copy of your resume to Dan Boersma - Dan\@LagunaSource.com 
Key terms: Clinical Project Manager, Clinical Program Manager, CRA, Clinical Research Associate, Clinical Trial Manager, Medical Device, Orthopedic, Orthopaedic.
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Privacy Notice: Weâll save your name, resume, and the email address you&apos;ve entered so that we can contact you about the status of your application if necessary, and for our internal reporting purposes. We will not disclose your e-mail address to anyone other than this employer.
]]></description>
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