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Company Contact Info
- Southborough, MA
- Olympus Surgical Technologies of America(OSTA)
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Senior Clinical Research Associate
Olympus Corporation of the Americas • Southborough, MA
Posted 27 days ago
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Southborough, MA - The Senior Clinical Research Associate (SCRA) 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. The incumbent assists in the design, development, organization, implementation and evaluation of scientifically valid clinical research. He/She effectively coordinates the activities of Clinical research team members and investigators, and ensures compliance with study protocols, applicable regulations, guidances, policies, and procedures. EOE M/F/D/V
* May serve as Clinical Study Project leader and/or 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.
* Maintain responsibility for clinical study activities and site management for multiple clinical sites for several ongoing clinical studies.
* Design and develop key clinical study documents (e.g. informed consent forms, study specific plans, study master file plan) and participate in preparation of data management plan (DMP); seek input as needed from cross-functional team members.
* Participate in site start-up activities including creation and shipment of the investigator site file, collection of essential regulatory documents, and IRB submission(s).
* Ensure all clinical site personnel are trained to study protocol, procedures, and local regulations; creates study specific training material and training log.
* Ship investigational devices and performs device accountability, as applicable.
* Prepare for and execute on-site qualification, study initiation, interim monitoring and close-out visits at clinical sites as necessary to ensure study requirements are being fulfilled.
* Conduct monitoring visits in compliance with the study specific Monitoring Plan, Standard Operating Procedures, Good Clinical Practices (GCP) and applicable government regulations and guidelines; ensure site compliance to protocol, review investigator site file, perform source document verification (SDV), query resolution, and documents adverse events.
* Communicate clearly with clinical sites; author monitoring reports, follow-up letters, study memos, and general correspondence.
* Maintain responsibility for site management for pre- and post-market studies ensuring successful conduct of clinical programs, and cross- functional strategies.
* Serve as a liaison for clinical trial agreement (CTA) and budget negotiations.
* Ensure maintenance of study master file to ensure compliance with internal procedures, and applicable country-specific regulations.
* Track progress of clinical studies with regard to budget, study milestones, and deadlines; clearly communicate study updates to management on a regular basis.
* Perform comprehensive literature searches to develop and maintain in-depth knowledge and understanding of current scientific literature required to support assigned product lines and related clinical studies, staying informed about applicable clinical landscapes and trends.
* Participate in study audits, as applicable.
* Perform all other essential duties as assigned.
(ONLY QUALIFIED CANDIDATES WILL BE CONSIDERED)
* Bachelor's Degree in a related field (e.g., biological, medical, public health, physical sciences, engineering) is required.
* Minimum of 5 years experience conducting clinical research in the medical device industry, with at least 3 of these years in a Clinical Research Associate role is required.
* Strong knowledge, understanding and application of principles, concepts and practices of clinical investigations/studies is necessary.
* Working knowledge of regulations and standards applied in clinical area and medical devices is essential.
* Experience with electronic data capture (EDC) systems is preferred.
* Experience monitoring approval and surveillance studies in support of PMA and 510(k) is necessary.
* Solid understanding of scientific/clinical research is desired.
* Strong analytical skills are essential.
* Basic understanding of statistics, statistical methods, and design of experiment is preferred.
* Must be an advanced user of Microsoft Office applications such as MS Word, Excel, Project, and PowerPoint.
* Must be detail oriented and well organized.
* Ability to independently set and manage multiple priorities is preferred.
* Ability to work effectively on a cross-functional team is desired.
* Must have the functional and technical knowledge and skills to do the job at a high level of accomplishment.
* Must possess ability to solves difficult problems with effective solutions; ask good questions and probe all fruitful sources for answers; can see underlying or hidden problems and patterns; is excellent at honest analysis; look beyond the obvious and doesn't stop at the first answer.
* Must spend his/her time and the time of others on what's important; quickly zero in on the critical few and puts the trivial many aside; can quickly sense what will help or hinder accomplishing a goal; eliminate roadblocks; create focus.
* Must relate well to all kinds of people, up, down, and sideways, inside and outside the organization; build appropriate rapport; listens, build constructive and effective relationships; use diplomacy and tact; truly values people; can diffuse even high-tension situations comfortably.
* Must have ability to travel domestically, at least 20% of the time; internationally, up to 10% of the time.
*Senior Clinical Research Associate initially will not have direct reports.