Sr. Clinical Research Associate

US-MD-Rockville
Job ID
7123
Experience (Years)
5
Category
Medical Device

Company Overview

Canon BioMedical, Inc., subsidiary of Canon U.S.A., Inc., is dedicated to extending innovative Canon core technologies into the burgeoning life sciences field — and to the introduction and marketing of vital, new-platform products in the critical area of molecular diagnostics. 
 
Canon U.S.A., Inc., is a leading provider of consumer, business-to-business, and industrial digital imaging solutions to the United States and to Latin America and the Caribbean markets. With approximately $29 billion in global revenue, its parent company, Canon Inc. (NYSE:CAJ), ranks third overall in U.S. patents granted in 2016† and is one of Fortune Magazine's World's Most Admired Companies in 2016. Canon U.S.A. is committed to the highest level of customer satisfaction and loyalty, providing 100 percent U.S.-based consumer service and support for all of the products it distributes. Canon U.S.A. is dedicated to its Kyosei philosophy of social and environmental responsibility. In 2014, the Canon Americas Headquarters secured LEED® Gold certification, a recognition for the design, construction, operations and maintenance of high-performance green buildings. To keep apprised of the latest news from Canon U.S.A., sign up for the Company's RSS news feed by visiting www.usa.canon.com/rss and follow us on Twitter @CanonUSA. For media inquiries, please contact pr@cusa.canon.com.

† Based on weekly patent counts issued by United States Patent and Trademark Office.

All referenced product names, and other marks, are trademarks of their respective owners.
We are an EEO/AA employer. Minority/Female/Individuals with Disabilities/Protected Veterans.

Position Overview

Canon BioMedical, Inc. in Rockville, MD is currently seeking a Sr. Clinical Research Associate to be responsible for facilitating and/or leading the product clinical development and testing-focused activities for Canon BioMedical, Inc.
 
#CBMI #LI-LT1

Responsibilities

- Clinical study preparation, which includes contributing to and facilitating the creation of the clinical study protocol (CSP), patient informed consent document (ICD), case report form (CRF) forms and other associated clinical study documentation in compliance with CBMI’s new product development or sustaining engineering clinical validation plan for the product; as well as CBMI’s good clinical practice policies, procedures and forms. A Sr. CRA will be responsible for leading (as well as contributing to and facilitating) the generation of these documents. Where a Contract Research Organization (CRO) is employed and performs the creation of these documents, the Sr. CRA will be responsible for facilitating CBMI’s oversight and approval of these documents.
- Institutional Research/Review Board (IRB) management, which includes facilitating or leading the engagement with an IRB regarding a proposed, planned, executed or closed clinical study. Such engagement may include obtaining and negotiating IRB approval for a study; addressing any study non-conformances (and associated corrections or corrective actions) cited by the IRB; and presenting to the IRB as needed requested status updates regarding the study.
- FDA Pre-Submission Meeting engagement, which includes leading the search and selection of a clinical key opinion leader (KOL) or clinical subject matter expert (SME) who will be best able to represent, speak to and defend CBMI’s clinical study plan with FDA during a Pre-Submission Meeting. The Sr. CRA will be in attendance at FDA Pre-Submission Meetings and is expected to provide support and contribute to the meetings to the betterment of CBMI and its presented clinical study content
- Assess site qualification potential, which includes reviewing study requirements; conducting study site selection visits and drafting study site selection visit evaluation reports. Where a CRO is employed and performs the study site visits and generates a list of candidate sites, the Sr. CRA will be responsible for facilitating CBMI’s evaluation of the CRO’s provided list of candidate study sites against CBMI’s clinical test plan requirements.
- Study start-up or implementation of clinical studies, which includes acting as the main liaison with investigators and their staff; ensuring compliance with terms and conditions; providing training to study site personnel and drafting the initiation visit reports. Where a CRO is employed and the CRO is responsible for the execution of clinical study start-up, the Sr. CRA will be the liaison and manager for the CRO in these activities.
- Study monitoring, which includes supervising the conduct of clinical studies: acting as liaison between study site personnel and the sponsor; performing monitoring in the field; ensuring compliance with protocols, regulatory requirements, and good clinical practices; drafting follow-up visit reports. In the instances where there is a clinical study protocol deviation, providing guidance to the study site and CBMI Project Core Team regarding the root cause analysis, impact assessment and any corrective action or correction that is required. Where a CRO is employed and the CRO is responsible for the execution of clinical study, the Sr. CRA will be the liaison and manager for the CRO in these activities and is also expected to periodically accompany the CRO on their study site monitoring visits.
- Ensures the quality and compliance of the clinical study, which includes desk-top and site inspections to verify materials and data integrity; assisting site personnel with internal audits or regulatory inspections; and performing ongoing follow-up with the CBMI new product development project core team and/or CRO project team.
- Clinical study closure, which will include verifying the integrity of investigator files (e.g., case report forms, data files, etc.); ensuring availability of clinical and non-clinical materials; jointly reviewing, verifying and confirming the closure status with investigators all of the applicable contracted, GCP and study obligations at the end of the study and writing closure visit reports.
- Contract Research Organization (CRO) selection and management, which includes identifying, facilitating and/or leading the selection of any needed CRO support for a new product development’s clinical program. A key requirement of the Sr. CRA will be to provide an assessment to CBMI if a CRO is needed and if so propose the scope of their involvement.
- Coordinate clinical trials by visiting trial sites regularly, acting as liaison between project managers, study site personnel and any contracted CRO or other supporting the clinical studies, maintaining the quality of the work and relationships, monitoring the conduct of clinical trials and compliance with established timelines, and ensuring the consistent and compliant execution of harmonization of CBMI monitoring practices.
- Ensure Quality Assurance of Projects by adhering to protocol regulatory requirements, good clinical practice regulations, and standard operating procedures, assessing the trial site and applicable personnel on an ongoing basis, ensuring compliance with the patient-consent process and verifying the receipt, handling, accounting, storage conditions, and availability of clinical products under investigation.

Qualifications

- Minimum of a Bachelor’s Degree, preferably in a related science (e.g. Nursing, Health Sciences, Health Policy, Medical Technology, etc.).
- 5+ years of relevant clinical research experience
- Knowledge and Skills in medical device and IVD industry, GCP and new product development
- Working knowledge and experience with GCP and successfully applying this knowledge in the support, oversight and management execution of the planning, running and closure of clinical studies required.
- Established and proven ability to adequately review, interpret, apply in a compliant manner and educate stakeholders on applicable acts, laws, regulations, policies, and guidances governing clinical studies or trials required.
- Excellent communication skills: written, verbal and presentation skills required
- Working knowledge and application of ISO 13485, 21CFR820, 21CFR11, etc.
- Strong problem solving and analysis skills
- Strong teamwork and interpersonal skills
- PC skills to include Microsoft Office (Excel, Access, Word and PowerPoint)
- Established and proven experience and ability to interact in a professional manner with external stakeholders such as customers, patients and regulators
 
- Able to differentiate between conflicting priorities and issues to identify underlying causes
- Demonstrated ability to manage multiple tasks and assess priorities effectively
- Must have ability to accommodate approximately 60% travel
If you are not reviewing this job posting on our Careers’ site https://www.usa.canon.com/internet/portal/us/home/about/careers, we cannot guarantee the validity of this posting. For a list of our current postings, please visit us at https://www.usa.canon.com/internet/portal/us/home/about/careers.
 

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