Clinical Research Associate, Level II
Employment Type: Full-Time
Working Location: CALIFORNIA, SAN JOSE; Alabama, Birmingham; Alabama, Huntsville; Alabama, Mobile; Alabama, Montgomery; Alaska, Anchorage; Alberta, Calgary; Alberta, Edmonton; Arizona, Flagstaff; Arizona, Phoenix; Arizona, Tucson; Arkansas, Fayetteville; Arkansas, Little Rock; BR, SAO PAOLO; British Columbia, Kelowna; British Columbia, Vancouver; COLORADO, GOLDEN; California, Baldwin Park; California, Burbank; California, Cypress; California, Downey; California, Fresno; California, Inland Empire; California, Irvine; California, Laguna; California, Long Beach; California, Los Angeles; California, Modesto; California, Newport Beach; California, Oakland; California, Ontario; California, Orange County; California, Rancho Cucamonga; California, Redding; California, Riverside; California, Sacramento; California, San Bernardino; California, San Diego; California, San Fernando Valley; California, San Francisco; California, Santa Barbara; California, Santa Clarita; California, South Bay; California, Sunnyvale; California, Ventura; California, West Covina; Canada; College Park, Maryland; Colorado, Colorado Springs; Colorado, Denver; Connecticut, Hartford; Connecticut, New Haven; Connecticut, Stamford; Delaware, Dover; Delware, Wilmington; District Columbia, Washington; FLORIDA, MIAMI; Florida, Clearwater; Florida, Fort Lauderdale; Florida, Fort Myers; Florida, Gainesville; Florida, Jacksonville; Florida, Orlando; Florida, Pensacola; Florida, St. Petersburg; Florida, Tallahassee; Florida, Tampa; Florida, West Palm Beach; Georgia, Atlanta; Georgia, Augusta; Georgia, Macon; Georgia, Savannah; Georgia, Valdosta; Hawaii, Honolulu; Idaho, Boise; Idaho, Idaho Falls; Illinois, Chicago; Illinois, Lombard; Illinois, Peoria; Illinois, Springfield; Indiana, Indianapolis; Iowa, Burlington; Iowa, Cedar Rapids; Iowa, Des Moines; Iowa, Iowa City; Kansas, Kansas City; Kansas, Topeka; Kansas, Wichita; Kennewick, Washington; Kentucky, Lexington; Kentucky, Louisville; Louisiana, Alexandria; Louisiana, Baton Rouge; Louisiana, Monroe; Louisiana, New Orleans; Louisiana, Shreveport; MASSACHUSETTS, LITTLETON; MASSACHUSETTS, SOUTHBOROUGH; MASSACHUSETTS, WALTHAM; MASSACHUSETTS, WESTBOROUGH; MEXICO, MEXICO CITY; MINNESOTA, BROOKLYN PARK; MISSOURI, ST. 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Are you looking for a company that cares about people's lives and health, including yours? At Olympus, we help make people's lives healthier, safer and more fulfilling, every day.
Let's inspire healthier lives, together.
The Clinical Research Associate (CRA) II is a member of the Clinical Affairs team, responsible for performing activities essential to providing clinical guidance, strategy and support for the evaluation of new technologies and products in clinical trials. CRA II assists in the design, development, organization, implementation and evaluation of scientifically valid clinical research. Effectively coordinates the activities of Clinical research team members and investigators, and ensures compliance with study protocols, applicable regulations, guidance, policies, and procedures.
* Serve as Clinical Study Project Coordinator under the direction of the Clinical Project Manager and/or as the Clinical Affairs representative on assigned project teams and/or Product Development Process (PDP) teams to provide clinical guidance, strategy, and support for the development of new technologies, new products, and extended product claims.
* Responsible for clinical study activities and site management for multiple clinical sites for several ongoing clinical studies.
* Designs and develops key clinical study documents (e.g. informed consent forms, study specific plans, study master file plan) and participates in preparation of data management plan (DMP); seeks input as needed from cross-functional team members.
* Participates in site start-up activities including creation and shipment of the investigator site file, collection of essential regulatory documents, and IRB submission(s).
* Prepares for and executes on-site qualification, study initiation, interim monitoring and close-out visits at clinical sites as necessary to ensure study requirements are being fulfilled.
* Conducts monitoring visits in compliance with the study specific Monitoring Plan, Standard Operating Procedures, Good Clinical Practices (GCP) and applicable government regulations and guidelines; ensures site compliance to protocol, reviews investigator site file, performs source document verification (SDV), query resolution, and documents adverse events.
* Responsible for site management for pre- and post-market studies ensuring successful conduct of clinical programs, and cross-functional strategies.
* Serves as a liaison for clinical trial agreement (CTA) and budget negotiations.
* Ensures maintenance of study master file to ensure compliance with internal procedures, and applicable country-specific regulations.
* Tracks progress of clinical studies to: budget, study milestones, and deadlines; clearly communicates study updates to management on a regular basis.
* Participates in study audits, as applicable.
* Bachelor's degree in a related field (e.g., biological, medical, public health, physical sciences, engineering).
* Minimum five 5 years experience in medical device industry.
* Minimum of five 5 years experience in clinical research, with at least three (3) years experience as a Clinical Research Associate.
* Ability to travel domestically up to 40% of the time. Some international travel is expected
* Strong knowledge, understanding and application of principles, concepts and practices of clinical investigations/studies.
* Working knowledge of regulations and standards applied in clinical area and medical devices.
* Experience with electronic data capture (EDC) systems.
* Experience monitoring approval and surveillance studies in support of PMA and 510(k).
* Solid understanding of scientific/clinical research. Strong analytical skills. Basic understanding of statistics, statistical methods, and design of experiment.
* Advanced user of Microsoft Office applications such as MS Word, Excel, Project, and PowerPoint.
* Detail oriented and well organized.
* Ability to independently set and manage multiple priorities.
* Ability to work effectively on a cross-functional team.
We realize work isn't just a job to you.
It's a big part of your life, but not the only part. That's why we offer competitive salaries, a robust 401(k) program, annual bonus program and comprehensive medical benefits, as well as tuition reimbursement, flexible schedules, parental and adoption leave, on-site services and Colleague Affinity Networks - so you can be ready for where life can take you.
Olympus is passionate about the solutions it creates for the medical, life sciences, and industrial equipment industries, as well as cameras and audio products. For more than 100 years, Olympus has focused on making people's lives healthier, safer and more fulfilling by helping detect, prevent, and treat disease, furthering scientific research, ensuring public safety, and capturing images of the world.
Olympus' Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce overall costs, and enhance the quality of life for patients. Olympus' Medical portfolio includes endoscopes, laparoscopes, and video imaging systems, as well as surgical energy devices, system integration solutions, medical services, and a wide range of endotherapy instruments for endoscopic and therapeutic applications. For more information, visit www.olympus-global.com.
Olympus…True To You. True To Society. True To LIFE.
It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.
Posting Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley ||