Job Description

About Orchestra BioMed

Orchestra BioMed is a biomedical innovation company accelerating high-impact technologies to patients through risk-reward-sharing partnerships with leading medical device companies. Orchestra BioMed’s vision is to accelerate medical innovation to patients through risk-reward-sharing partnerships with leading medical device companies. Orchestra BioMed’s partnership-enabled business model focuses on forging strategic collaborations with leading medical device companies to drive successful global commercialization of products it develops. Orchestra BioMed is led by a highly accomplished, multidisciplinary management team and a board of directors with extensive experience in all phases of therapeutic device development. Orchestra’s business was formed in 2018 by assembling a pipeline of multiple late-stage clinical product candidates originally developed by its founding team. Its flagship product candidates are BackBeat CNT for the treatment of hypertension, the leading risk factor for death worldwide, and Virtue SAB for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Orchestra BioMed has a strategic collaboration with Medtronic for the development and global commercialization of BackBeat CNT for the treatment of hypertensive patients indicated for a pacemaker and strategic partnership with Terumo for the development and global commercialization of Virtue SAB for the treatment of coronary and peripheral artery disease.

Job Summary

The 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 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. However, for the right candidate this role could be remote.

  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 for trial 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 study team 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%).

Must be authorized to work in the United States and not require sponsorship in the future. 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. 3+ years’ experience in the conduct of pivotal clinical trials for medical devices in the cardiovascular space.
• Minimum 1 year experience with on-site monitoring and/or minimum 2 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 including ability 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 technology Expert proficiency with Word, Power Point, Excel

A current US work authorization is required. 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.

EQUAL OPPORTUNITY EMPLOYER Orchestra 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.

Orchestra BioMed has a multi-part and competitive compensation structure:

• Competitive base salary based on experience
• Annual bonus based on exceptional company and individual performance
• Equity grants appropriate for role
• We offer a comprehensive and competitive benefits package which includes health, dental, and vision, 401k as well as other benefits.

Our Vision

To be a leader in bringing high impact medical innovations to life through risk-reward sharing partnerships.

  Our Mission

We 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 Values

We care  about patients, physicians, partners, and each other 

We are creative , open-minded, adaptable and think “outside the box”

We are driven  to always do our best and we do not give up

We deliver  and are accountable to promised results

  Important notice to employment businesses/agencies

Orchestra 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.

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