Sr. CRA (In House)

About Orchestra BioMedOrchestra BioMed (Nasdaq: OBIO) is a biomedical innovation company accelerating high-impact technologies to patients through strategic partnerships with market-leading global medical device companies. Its partnership-enabled model is designed to drive successful global commercialization of the products it develops in collaboration with these industry leaders. Orchestra BioMed’s lead product candidate is Atrioventricular Interval Modulation (AVIM) Therapy for the treatment of hypertension, the leading risk factor for death worldwide. Orchestra BioMed is also developing the highly differentiated Virtue® Sirolimus AngioInfusion™ Balloon (SAB) for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Orchestra BioMed has strategic collaboration with Medtronic, one of the largest medical device companies in the world, for development and commercialization of AVIM therapy for the treatment of hypertension in pacemaker-indicated patients, and a strategic agreement with Terumo, a global leader in medical technology for development and commercialization of Virtue SAB for the treatment of artery disease. For further information about Orchestra BioMed, please visit www.orchestrabiomed.com and follow us on LinkedIn.Job Summary The Sr. Clinical Research Associate (CRA) will assist with the implementation and execution of Clinical trials in the cardiovascular space working with Clinical team members and the assigned CRO. The Sr. CRA will assist in providing operational support of assigned study responsibilities from start-up through database lock and closeout activities. This person will actively contribute to the development of clinical trial processes, study tools and documentation. Ideally the person in this role will be located in the Philadelphia, New Jersey, New York, Connecticut region with the intention of working in our New Hope, PA or NYC office in a hybrid capacity.Role and Responsibilities – Including but not limited to: Ensure that clinical trials are conducted consistent with OBIO’s strategic development plan, the company’s quality procedures and with the highest ethical and scientific standards.Support site feasibility activities including the implementation of any local criteria for site selection, consistent conduct of pre-trial assessment visits and follow-up.Support activities related to site initiation and start-up, site monitoring, site management and site-study close out according to the applicable SOPs.Support local project planning activities to meet recruitment targets and to deliver high quality data on time and within study budget.Ensure that all safety events and device deficiencies are reported within reporting timelines and documented as appropriate.Contribute to drafting and editing study and site level documents and worksheets.Support site staff training activities and accurate filing of documentation in the eTMF.Ensure site study supplies (e.g., blood pressure devices, blood and urine kits) are adequate fortrial conduct at each site.Ensure site staff completes data entry and resolves queries within the expected timelines.Assist data management with ensuring the accuracy, validity and completeness of data collected at trial sites.Maintain and update trial management systems; use management reports to manage trial site status and progress.Review monitoring reports and follow-up letters, as needed.Conduct monitoring oversight visits, as required.Oversee site compliance by tracking protocol deviations and monitoring action items.Assist with generating and reviewing site payment invoices, as needed.Assist with reviewing vendor invoices.Assist with ensuring study documents are appropriately tracked in accordance with the studyteam training plan.Ensure that clinical studies are conducted according to GCP, all other applicable regulations, and OBIO SOP’s and policies.Give input into the continuing development and maintenance of processes and SOPs and adaptation to optimally address the changing internal and external environment.Pro-actively identify and address process and/or SOP-related obstacles that may impact effective study conduct.Share accountability with others for a positive team spirit that is characterized by mutual support, understanding, encouragement, and an active exchange of new ideas.Other tasks may be assigned based on business needs aligning with the individual’s skillset.Travel required domestically (approximately 20%).A current US work authorization is required in order to be employed by Orchestra BioMed. The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. The level of this position will be based on the final candidate’s qualifications. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.Qualifications – Knowledge & Skills:Minimum bachelor’s level degree in a biomedical or other relevant scientific discipline.4+ years’ experience in the conduct of pivotal clinical trials for medical devices in the interventional cardiology space (balloons)Minimum 1 year experience with on-site monitoring and/or minimum 1.5 years’ experience in clinical trial oversight responsibilities at the CRA level.Knowledgeable about GCPs, including the standards set forth in ISO 14155:2020.Knowledgeable about Good Documentation Practices and ALCOA+ characteristics critical to data integrity Strongly goal-oriented and highly motivated with a high energy level.Understanding the process and methodology used to develop study plans.Demonstrated ability to work well in a collaborative and dynamic team environment, set priorities, and drive results.Demonstrated superior oral and written communication skills and presentation skills includingability to communicate complex issues in a succinct and logical manner.Strong interpersonal skills and ability to collaborate effectively with various technical area experts.Demonstrated flexibility in responding to changing priorities or dealing with unexpected events.Ability to identify and respond quickly to opportunities and difficulties.Affinity for learning new technologyExpert proficiency with Word, Power Point, ExcelWhy Join Orchestra BioMedIn addition to an interesting, inclusive, and collaborative work environment, Orchestra BioMed is proud to offer a comprehensive compensation package. Along with a competitive salary, including annual bonus and equity eligibility, health insurance (for employee and family), prescription drug coverage, 401(k), paid holidays, PTO & sick time, Life & AD&D insurance, disability insurance, dental, vision, pet insurance and more.Our VisionTo be a leader in bringing high impact medical innovations to life through risk-reward sharing partnerships.Our MissionWe will work passionately to apply our collaboration-based business model to bring high-impact medical innovations to live and create extraordinary value for patients, care providers, partners and stakeholders.Our ValuesWe care about patients, physicians, partners, and each otherWe are creative, open-minded, adaptable and think “outside the box”We are driven to always do our best and we do not give upWe deliver and are accountable to promised resultsEQUAL OPPORTUNITY EMPLOYEROrchestra BioMed is committed to non-discrimination with respect to race, creed, color, religion, age, disability, sex, sexual orientation, gender identity and expression, marital status, national origin, political opinions or affiliations, genetic information, and veteran status in all aspects of employment including recruitment, hiring, promotions, transfers, discipline, terminations, wage and salary administration, benefits, and training.Important notice to employment businesses/agenciesOrchestra BioMed does not accept referrals from employment agencies unless written authorization from the Orchestra BioMed Human Resources department has been provided. In the absence of written authorization, any actions undertaken by employment agencies shall be deemed to have been performed without our consent and therefore Orchestra BioMed will not be liable for any fees arising from employment agency referrals in respect to current or future position vacancies at Orchestra BioMed.