About

Clinical Research Associate (Field Operations)

PURPOSE OF POSITION:

Conduct clinical research trials by effectively coordinating the activities of study coordinators and investigators and by ensuring compliance with study protocols, FDA and other Ministry of Health regulations, IRB requirements and overall clinical objectives.  Assist in the preparation of regulatory filings.

MAJOR DUTIES AND RESPONSIBILITIES:

• Act as a company representative at clinical cases by traveling to field sites, observing and preparing written reports on procedures, ensuring proper collection of data and perform investigational device set-up, as required.
• Assist to identify, evaluate and establish trial sites, and manage site closure at completion of trial.
• Oversee patient screening and enrollment at assigned clinical study sites.
• Work with investigation team to ensure data is entered, imaging studies are submitted, and reports are complete and entered in database.
• Manage day-to-day interactions with investigators and investigative team members and liaise with in-house Clinical Affairs staff.
• Monitor ongoing compliance to study protocols.  Ensure adherence to FDA and IRB requirements.   Work with investigators to quickly and effectively resolve discrepancies.  Review source documentation, case report forms, and data reports for accuracy and ensure the timely submission of such documentation. Perform interim monitoring visits per SOP.
• Develop and direct site training and in-services during site qualification and initiation phases and onboarding new study site personnel.  Train staff on therapeutic areas, protocol requirements proper source documentation and case report completion. Develop materials for clinical training sessions.
• Coordinate meetings with site coordinators and investigators.
• Identify and prepare written reports for adverse events, as needed.
• Assist in the preparation of IDE, 510(k), PMA and related regulatory filings.
• Ensure accurate inventory of investigative devices.
• Prepare accurate and timely reports to management.
• 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.
• Maintain current knowledge of applicable clinical literature.
• Attend relevant scientific and/or medical meetings.
• Support company goals and objectives, policies and procedures, and compliance with Good Clinical Practices, Good Manufacturing Practices and FDA regulations.  Ensure compliance with Quality System Regulations and ISO 9001, EN 46001, and MDD requirements.
• Perform other duties as assigned.

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 as well as the ability to travel up to 75%

Clinical Research Associate (Clinical Quality)

PURPOSE OF POSITION:

Support the Clinical Affairs team to ensure the clinical trial is operating in accordance with the clinical protocol(s); Federal Regulations; any other applicable policies, regulations, procedures, and/or guidelines to ensure data integrity and Trial Master Files are maintained. Collaborates with field operations and study site personnel to ensure integrity of clinical and/or compliance data.

MAJOR DUTIES AND RESPONSIBILITIES

• Evaluate and establish trial sites and manage site closure at completion of trial.
• Oversee, review and approve, and file site qualification, initiation, interim monitoring, and site closure visit communications and reports.
• Monitor ongoing compliance to study protocols.  Ensure adherence to FDA and IRB requirements. Work with Clinical Affairs staff to quickly and effectively resolve discrepancies.  Review source documentation, case report forms, and data reports for accuracy and ensure the timely submission of such documentation.
• Perform quality assurance audits on eTMF, prioritizing as needed; determine corrective actions where needed and coordinate their resolution(s), may include: reconciling missing records, working with investigative teams and Field Operations staff members, initiating CAPAs, etc.
• Assist in clinical protocol, informed consent form, case report form, and other study materials development.
• Prepare and complete central IRB submissions for current clinical trial(s).
• Monitor and track site IRB expiration dates for upcoming continuing reviews; ensure sites have current trial materials for submissions.
• Ensure that clinical files are current and complete; review incoming study-related documents for completion and accuracy.
• Oversee and document accurate dispensation, inventory and reconciliation of investigative devices.
• Develop and direct sponsor training and in-services and onboarding new study site personnel.  Develop materials for clinical training sessions.
• Order, track and manage trial materials.
• Update and maintain current trial(s) activity on clinicaltrials.gov website.
• Review, assess, create, and update Clinical Quality and Monitoring SOPs, Monitoring Plans and other clinical affairs forms.
• Prepare accurate and timely reports to management.
• 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.
• Maintain current knowledge of applicable clinical literature.
• Attend relevant scientific and/or medical meetings, as required.
• 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.
• Assist in the preparation of interim analysis and final report preparation for IDE, 510(k), PMA and related regulatory filings.
• Serve as clinical representative on project teams, as needed.

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.
• 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.
• CQA certification is strongly preferred

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.

Senior Director of Clinical Affairs

PURPOSE OF JOB:

We are seeking an experienced Clinical Research professional to develop and implement policies, procedures, practices and strategy for our growing Clinical Affairs department.

MAJOR DUTIES AND RESPONSIBILITIES:

• Develop and implement clinical research strategy and proactively manage clinical research initiatives to meet corporate goals and objectives.
• Work closely with marketing and training teams to analyze and summarize internal/external clinical data for optimized promotion of the Company’s clinical solutions.
• Develop and manage clinical trials including site selection and onboarding in addition to driving trial enrollment.
• Maintain close working relationships with Key Opinion Leaders, other investigating physicians, and site research coordinators to maximize quantity and quality of Ancora Heart’s research and publication results.

EDUCATION REQUIREMENTS:

• Bachelors degree in life sciences, nursing or equivalent experience is required

EXPERIENCE REQUIREMENTS:

• Minimum of ten years of related experience, preferably in the medical device field in addition to at least five years management experience, preferably with a background in heart failure treatment.

OTHER QUALIFICATIONS:

• Experience in clinical study design, management and analysis is also required as is prior experience in interfacing with FDA.
• Thorough working knowledge of the medical device industry is required as is the ability to exercise sound making and good judgment consistent with a senior level position.

Office Administrator

Proactively support company goals and objectives, policies and procedures, Ancora Quality System, regulations and regulatory requirements.  Ancora Heart employees must demonstrate commitment to providing our customers with high quality medical devices.

PURPOSE OF JOB:

• Support the smooth functioning of Ancora Heart’s corporate office and perform administrative tasks as assigned.

MAJOR DUTIES AND RESPONSIBILITIES:

• Greet visitors and take delivery of shipments to the Burton Drive facility.
• Answer corporate telephone and appropriately direct callers.
• Create shipping labels and coordinate shipments from the Burton Drive facility.
• Collect and distribute mail.
• Serve as the primary interface with janitorial staff, facility service providers, and property owners.
• Review and process expense reports and ensure compliance with corporate travel policy.
• Collect and scan PTO forms, update log and forward to Senior Director, Finance.
• Reconcile monthly credit card bills.  Gather all supporting documentation, scan and save to corresponding Box folder.
• Serve as the key interface with corporate IT consultants.  Work with members of the administration team to quickly and effectively resolve IT issues.
• Coordinate regular IT/Cyber Awareness training.
• Assist, on an as needed basis, in the planning and execution of both onsite and offsite meetings.  Prepare rooms in advance of meetings.
• Maintain office supplies, food and beverages including inventory, ordering, and stocking.
• Manage Sunshine Act tracking and submission.
• Complete corporate census and survey requests.
• Provide regular feedback to management regarding project status, as well as other critical issues which affect the attainment of project completion dates.
• Maintain a professional and credible image with key physicians, consultants, suppliers, and co-workers.
• Maintain corporate quality systems.
• Work all required overtime.
• Perform other duties as assigned.

EDUCATION REQUIREMENTS:

• BA/BS degree preferred.

EXPERIENCE REQUIREMENTS:

• Minimum five years related experience.

OTHER QUALIFICATIONS:

• Excellent communication and interpersonal skills required.
• Mastery of Microsoft Office programs.
• Ability to work independently.
• Willingness to multi-task and solve problems.