Johnson & Johnson companies are equal opportunity employers.
SR ASSOCIATE CLINICAL RESEARCH-5771140310
Description
Acclarent, Inc., a member of the J&J Family of Companies is actively recruiting for a Senior Clinical Research Associate (CRA) to be located in Menlo Park, CA.
Acclarent, Inc. is a medical device company in Menlo Park, CA that was established in June of 2004. The company is dedicated to the development of innovative devices providing new technologies to further meet the needs of ENT patients.
Acclarent's initial focus is on achieving the goals of sinus surgery with novel, endoscopic, catheter-based tools - Balloon Sinuplasty™ devices. Through the Balloon Sinuplasty™ technology and our Relieva® product portfolio we offer ENT patients another option to conventional endoscopic surgical technologies. FDA clearances for these devices were completed in 2005 and the products were commercially launched in the US that same year.
Through our core technologies and commitment to innovation, Acclarent will continue to advance novel devices in all areas of ENT. The Senior Clinical Research Associate (CRA) will support pre- and post-market otology clinical studies worldwide.
Responsibilities include clinical trial protocol development, case report form (CRF) development, IRB/Ethics submissions, site initiation activities, clinical monitoring, interpretation of clinical data, management of investigational sites, support of clinical cases, and other clinical activities. This position will serve as the clinical representative on one or more product development teams and will be responsible for conducting risk analysis documentation for specific projects.
Qualifications
A minimum of a Bachelor’s degree is preferred, an RN or RT is a plus. A minimum of 5 years of experience in clinical research, clinical operations or relevant experience is required. Medical device industry experience required. Knowledge and experience in supporting device pre- and/or post-market clinical studies is required. This position will interface with opinion leaders in the field of ENT and must be capable of representing the company in a professional and appropriate manner. Specific experience in interfacing with ENT specialists is an advantage. A basic understanding of otologic disease and therapies is an advantage. Must be able to read and interpret clinical data/professional literature. Thorough knowledge of Good Clinical Practice (GCP) is required. Experience with medical or technical writing is preferred. Applicant must have excellent verbal and written communication skills. Applicant must be detail-oriented, work well with cross-functional teams, exhibit initiative and be passionate about their job. Applicant should be motivated and a self-starter who can work independently once projects have been assigned. This position requires 25% - 50% travel in the US and worldwide.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W:LI NA
Primary Location:North America-United States-California-Menlo Park
Organization: Acclarent, Inc. (6206)
Job Function: Clinical Research non-MD
Certain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
EEO is the Law
EEO is the Law GINA Supplement
SR ASSOCIATE CLINICAL RESEARCH-5771140310
Description
Acclarent, Inc., a member of the J&J Family of Companies is actively recruiting for a Senior Clinical Research Associate (CRA) to be located in Menlo Park, CA.
Acclarent, Inc. is a medical device company in Menlo Park, CA that was established in June of 2004. The company is dedicated to the development of innovative devices providing new technologies to further meet the needs of ENT patients.
Acclarent's initial focus is on achieving the goals of sinus surgery with novel, endoscopic, catheter-based tools - Balloon Sinuplasty™ devices. Through the Balloon Sinuplasty™ technology and our Relieva® product portfolio we offer ENT patients another option to conventional endoscopic surgical technologies. FDA clearances for these devices were completed in 2005 and the products were commercially launched in the US that same year.
Through our core technologies and commitment to innovation, Acclarent will continue to advance novel devices in all areas of ENT. The Senior Clinical Research Associate (CRA) will support pre- and post-market otology clinical studies worldwide.
Responsibilities include clinical trial protocol development, case report form (CRF) development, IRB/Ethics submissions, site initiation activities, clinical monitoring, interpretation of clinical data, management of investigational sites, support of clinical cases, and other clinical activities. This position will serve as the clinical representative on one or more product development teams and will be responsible for conducting risk analysis documentation for specific projects.
Qualifications
A minimum of a Bachelor’s degree is preferred, an RN or RT is a plus. A minimum of 5 years of experience in clinical research, clinical operations or relevant experience is required. Medical device industry experience required. Knowledge and experience in supporting device pre- and/or post-market clinical studies is required. This position will interface with opinion leaders in the field of ENT and must be capable of representing the company in a professional and appropriate manner. Specific experience in interfacing with ENT specialists is an advantage. A basic understanding of otologic disease and therapies is an advantage. Must be able to read and interpret clinical data/professional literature. Thorough knowledge of Good Clinical Practice (GCP) is required. Experience with medical or technical writing is preferred. Applicant must have excellent verbal and written communication skills. Applicant must be detail-oriented, work well with cross-functional teams, exhibit initiative and be passionate about their job. Applicant should be motivated and a self-starter who can work independently once projects have been assigned. This position requires 25% - 50% travel in the US and worldwide.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W:LI NA
Primary Location:North America-United States-California-Menlo Park
Organization: Acclarent, Inc. (6206)
Job Function: Clinical Research non-MD
Certain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
EEO is the Law
EEO is the Law GINA Supplement