AtriCure, Inc. provides innovative technologies for the treatment of Atrial Fibrillation (Afib) and related conditions. Afib affects more than 33 million people worldwide. Electrophysiologists and cardiothoracic surgeons around the globe use AtriCure technologies for the treatment of Afib and reduction of Afib related complications. AtriCure's Isolator® Synergy™ Ablation System is the first and only medical device to receive FDA approval for the treatment of long standing persistent Afib and we have treated over 200,000 patients over the past ten years. Additionally, our AtriClip Left Atrial Appendage (LAA) Exclusion System products are the most widely used LAA management devices worldwide, with more than 130,000 implanted to date. For more information, visit AtriCure.com or follow us on Twitter @AtriCure.
This regionally based position will be responsible for clinical studies, site management, and compliance monitoring of assigned clinical projects undertaken in support of the aMAZE Trial, a prospective, multi-center, randomized controlled Trial evaluating the LARIAT® Suture Delivery Device (LARIAT) and / or associated marketing initiatives. This position must ensure that all activities are conducted in accordance with government regulations (FDA, MDD, and International) and company's operating procedures. Will be responsible for clinical site monitoring at a limited number of study centers and may coordinate monitoring activities for other designated filed monitors.
*Position can be remote preferably in Midwest or Southwest region.
ESSENTIAL FUNCTIONS OF THE POSITION:
- Serves as primary liaison for assigned study centers; collaborate with Trial site and field procedural team to execute on subject recruitment goals; manage site communications and study-related activities to ensure compliance to protocol, ICH/GCP, and applicable local and regulatory authorities; accountable for data integrity, patient safety and regulatory compliance for assigned sites.
- Prepares and documents study plans, contracts, budgets, informed consents, IRB submissions, case report forms (CRFs) and other study related materials to assure quality, consistency, compliance organization, storage and accuracy across assigned projects.
- Contributes to clinical study design, proposals, protocols, etc. Understanding basic scientific content, experimental design and analytical approaches used.
- Contribute to company's clinical operating procedures related to GCP monitoring.
- Conduct site monitoring (qualification, initiation, interim monitoring and close out visits) to insure and document site is trained to follow study procedures, is adhering to protocol, is implementing corrective actions as necessary, and is adhering to regulations and GCP for adverse event reporting.
- Assists in assuring both regulatory and clinical compliance for all assigned clinical projects; identify areas of non-compliance and ensure issues are addressed, clearly communicated, documented and escalated as required through monitoring visits, regular site contact, analyzing study metrics, and general study data overview.
- Maintains an awareness of and disseminates information to management and staff that may impact clinical studies by reviewing key literature, trade journals, and by attending conferences/seminars.
- Liaises with CROs and work with data management and biostatistics.
- Participates in the evaluation and selection of clinical sites and relevantt clinical meetings (investigator meetings, steering committee, etc.) as appropriate.
- Assists in thet coordination of site contract and budget process.
- Ability to write clear, succinct and detailed clinical study monitoring and study progress reports.
- Maintains open, positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors to successfully achieve all organizational objectives and milestones.
- Participates and represents clinical department during cross-functional project team meetings.
- Performs other essential functions and responsibilities as determines by the company/manager from time to time.
ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:
- Regular and predictable worksite attendance
- Ability to work under fast-paced conditions
- Ability to make decisions and use good judgment
- Ability to prioritize various duties and multitask as required
- Ability to successfully work with others
- Additional duties as assigned
- Bachelor's degree required or demonstrated equivalent combination of education, training and experience. CRA certification will be considered in lieu of a bachelor's degree.
- 2-4 years clinical research experience in a cardiology research environment, medical device trial experience required; previous industry experience preferred.
- Broad knowledge of GCPs, ICH and FDA regulating requirements governing human clinical trials and auditing.
- Sound knowledge in FDA and EU clinical trials regulations, IRBs, clinical trial monitoring and auditing.
- Demonstrates advanced judgement and decision-making ability in the execution and oversight of clinical study sites.
- Excellent interpersonal and relationship building skills.
- Proven leadership/influencing skills.
- Ability to work independently and set/manage multiple priorities.
- Excellent planning, analytical, and problem skills.
- Excellent verbal and written communications skills is essential.
- Ability to work with people at all levels of the organization.
- Proficiency with Microsoft Office, electronic data capture and other computer data acquisition, data analysis, graphing and plotting results and report writing.
- Ability to travel 25-50% when study(s) are activated.
- Certification as Clinical Research Associate / Professional
- Ability to regularly walk, sit, or stand as required
- Ability to occasionally bend and push/pull
- Ability to regularly lift up to 10 pounds, occasionally lift up to 20 pounds
- Ability to pass pre-employment drug screen and background check
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