About

Clinical Research Associate (Device Accountability)

PURPOSE OF POSITION:

Support the Clinical Affairs team to ensure investigational device accountability such that the clinical trial is operating in accordance with the clinical protocol(s); Federal Regulations 21CFR821; any other applicable policies, regulations, procedures, and/or guidelines to ensure data integrity and Trial Master Files are maintained. Support the Clinical Operations team to ensure integrity of clinical and/or compliance data.

MAJOR DUTIES AND RESPONSIBILITIES:

• Verify, in conjunction with the Operations team, quantities, lot numbers, and expiration dates of outgoing shipments.
• Verify data in outgoing shipment manifests to include specific details regarding packing lists, device accountability log information, addresses, site specific information (i.e., contact name and number).
• In a timely manner, confirm receipt of product at the site and ensure the completion and collection of manifest documentation.
• Troubleshoot and resolve any issues that arise during transit, delivery and receipt of shipments.
• In conjunction with Site Management and Field Operations, ensure the completion of site training for the receipt and handling of investigative product.
• With Therapy Development and Field Operations teams, review and reconcile post-implant devices.
• Collect and review Device Use Forms and Device Accountability Logs prior to return shipments.
• Coordinate and expedite device returns including creation of FedEx labels.  Ensure complete and accurate documentation.
• With the Operations staff, ensure the accuracy of return shipments, restocking, and tracking of devices.
• With Operations and Clinical Operations staff, create and maintain a system for the accurate tracking of devices returned and dispositioned (i.e., restocked, disposed, or recommissioned.)
• With Operations and Clinical Field Operations staff, fully review, reconcile, and file all documentation related to device accountability.
• Order, track and manage Clinical Trial materials.
• Manage in-house filing of critical materials.
• As needed, complete projects and tasks as assigned by the Clinical Affairs team.
• Work with Site Management to generate information and distribute EU and US study newsletters.
• Review, assess, create and update clinical quality and monitoring SOPs, monitoring plans, and other clinical affairs forms.
• Prepare Essential Document Tracker Status report as needed.  Perform comprehensive eTMF audits.
• Work with Field and Clinical Operations teams to maintain accurate study documents.
• Complete projects and tasks in an aggressive manner consistent with corporate objectives. Keep supervisor informed of changes in work schedule and/or workload.
• Regularly recognize problems and recommend and implement methods of conduct of clinical study.
• Perform other duties as assigned.
• Support company goals and objectives, policies and procedures, and compliance with Ancora Heart SOPs, Good Clinical Practices, Good Manufacturing Practices and FDA regulations.  Ensure compliance with Quality System Regulations and ISO 9001, EN 46001, and MDD requirements.

EDUCATION REQUIREMENTS:

• BS preferred in Life Sciences, Medicine, or other technical discipline.

EXPERIENCE REQUIREMENTS:

• Minimum five years related experience in health-related field in addition to working knowledge of FDA regulatory requirements.      

OTHER QUALIFICATIONS:

• Must possess excellent written and verbal communication skills.
• Able to travel and work in the Santa Clara Office
• Must be willing and able to travel to work related meetings and seminars, as needed.
• May require the ability to deliver speeches and/or presentations effectively to a variety of audiences.

Clinical Safety Associate

PURPOSE OF JOB:

The Clinical Safety Associate assists the Safety Manager and is responsible for the oversight of the adverse events and product experiences reported within a clinical trial as directed by the Safety Manager. The Clinical Safety Associate assists with ensuring the appropriate reporting of the events to the necessary internal departments and applicable Authorities throughout the life of the trial.

The Clinical Safety Associate assists the Safety Manager who acts as a liaison between the internal departments as well as to external customers such as CROs, Clinical Events Committees and Data Safety Monitoring Boards associated to the trial.

MAJOR DUTIES AND RESPONSIBILITIES:

• Assist with all activities related to establishing and managing all safety-related processes as directed by the Safety manger to include:
  • Participate in the formulation of case report forms, specifically with regards to reporting and management of adverse events.
  • Support preparation of safety section of clinical study reports, Clinical Expert reviews, clinical section of device reports, and other report documents as needed to support regulatory filings to US and International regulatory bodies.
  • Review clinical safety databases for adverse events and device deficiencies and compose safety narrative reports.
  • Assist sites with subject evaluation and protocol adherence for adverse event reporting timelines.
  • Assist managing Clinical Events Committee (CEC), Data and Safety Monitoring Board (DSMB) and Safety outsource activities.
  • Collaborate with team to resolve complex or unclear situations.
• Maintain a professional and credible image with clinical investigators, hospital staff and other customers, FDA, Notified Bodies, and other regulatory bodies, consultants, vendors, and co-workers.
• Maintain current knowledge of applicable clinical literature.
• Attend relevant meetings as appropriate.
• Support company goals and objectives, policies and procedures, and compliance with Good Clinical Practices and FDA regulations.
• Perform other duties as assigned.
• Keep manager informed of changes in work schedule/and or workload.

EDUCATION REQUIREMENTS:

Registered Nurse (Associate degree); Bachelor’s degree in a Scientific discipline, Life Sciences, Medicine, or other technical discipline.

EXPERIENCE REQUIREMENTS:

• Experience of at least 5 years in the medical industry in addition to at least 2 years of Safety monitoring experience.
• Experience in conducting clinical trials.
• Clinical knowledge and understanding in medical record and medical diagnostic report review.

OTHER QUALIFICATIONS:

• Excellent internal and external customer service skills
• Excellent written and verbal communication skills
• Detail oriented and ability to problem solve
• Able to make evaluative judgements
• Able to work independently and in a team environment
• Able to develop and deliver presentations to a variety of audiences
• Able to provide technical advice, guidance, and support to others in your area of expertise

Manufacturing and Process Engineers

PURPOSE OF JOB:

• Support the company’s transition from clinical stage to commercialization within manufacturing, process, and automation engineering. Evaluate and optimize existing processes, design & implement custom fixtures, tooling, automated equipment within and outside a cleanroom environment.  Work closely with the R&D, Operations, and Quality Systems staffs to improve existing processes and perform process validations.  This hands-on role requires accountability and the ability to work with minimal supervision.

MAJOR DUTIES AND RESPONSIBILITIES:

• Design, document, assemble, and qualify production assembly / test / inspection fixtures and equipment.
• Specify, procure and implement off the shelf automated and semi-automated equipment
• Design, develop and implement custom equipment as-needed.
• Create verification or validation protocols, execute studies and/or tests, and author and release subject reports.
• Perform characterization studies and Design of Experiments (DoE).
• Author and perform validation/verification of processes/inspection methods for manufacturing (IQ, OQ, PQ).
• Write and maintain manufacturing documentation including material and component specifications, work instructions, BOMs, routers, Process FMEAs, DMR, protocols, reports, and DHF documents.
• Maintain compliance with Ancora Heart’s quality systems including all applicable SOPs, non-conforming materials disposition, corrective action investigations and closure, and Engineering Change Order (ECO).
• Train operators on new processes, tools, and equipment.
• Work as the liaison among R&D, Operations, and Quality Systems to ensure a smooth transition of design changes, tooling, and fixturing.
• Assure product and process quality by designing testing methods; testing sub-assemblies, finished product and process capabilities.
• Develop, qualify and implement processes to improve manufacturability.
• Complete projects and tasks in a timely manner consistent with corporate objectives. Keep manager informed of changes in work schedule and/or workload.
• Maintain compliance to QSR systems in coordination with the Document Control and Quality Assurance functions.
• Support company goals and objectives, policies and procedures.
• Perform other duties as assigned.

EDUCATION REQUIREMENTS:

• Minimum B.S. in Mechanical Engineering, Biomedical Engineering, Materials Engineering, or similar Engineering discipline.

EXPERIENCE REQUIREMENTS:

• Minimum 5 years of related experience

OTHER QUALIFICATIONS:

• Knowledge of FDA, QSR and MDR regulations and relevant FDA Guidance and ISO standards.
• Strong background in IQ/OQ/PQ,
• SPC
• PLC programming, operation
• Ability to work in a CER ISO 7 environment, engage with medical device assemblers to learn and understand current manufacturing challenges.
• Strong background in DFMEA, SHA, test methods, quality inspection methodology, report writing.
• Flexibility to perform a wide range of activities in parallel.
• Strong communication skills, sound judgement
• Willingness and ability to work independently and in teams
• Experienced with Mini-Tab and SolidWorks
• Skilled in all Microsoft Office products, including Excel, Word, and PowerPoint.