Sr. Clinical Research Associate, Akura Medical

Akura Medical, a Shifamed Portfolio Company, is focused on a differentiated approach delivering an effective solution to address the major challenges of venous thromboembolism (VTE). Akura recently announced the first-in-human use of its mechanical thrombectomy platform. Each year VTE affects as many as 900,000 Americans, resulting in about 100,000 premature deaths. To learn more about Akura Medical, please visit www.akuramed.com.

About Shifamed

Founded in 2009 by serial entrepreneur Amr Salahieh, Shifamed LLC is a privately held medical device innovation hub focused on the development of novel medical products to address clinical needs in the rapidly evolving fields of cardiology and ophthalmology.

Description

The Sr. Clinical Research Associate/Engineer will play a key role to proactively monitor the conduct and progress of clinical studies to ensure compliance with the study protocol, standard operating procedures, good clinical practices, and applicable regulatory requirements. The candidate will lead the clinical site support throughout the lifecycle of the project and liaise with internal team members and external clinical sites, investigators, consultants, and vendors involved in study execution. In addition, the candidate will interact with the internal development team in the preclinical stage in the evaluation of new products and services. This is a full time on-site position and will require reporting to our offices located in Los Gatos, CA.

Responsibilities, Skills & Hands-On Experience

• Lead clinical research activities to ensure successful execution of clinical studies.
• Demonstrate understanding of the therapeutic area of interest and the study protocol assigned.
• Oversee the conduct of the clinical studies at participating clinical sites to ensure compliance to the protocol, standard procedures, good clinical practice, and regulatory requirements.
• Contribute to review and development of protocol, investigator brochure, informed consent form, case report forms, monitoring plans, and other study reports.
• Help identify suitable clinical sites, manage site start-up activities, and support participating sites with IRB/EC preparation and submission.
• Manage clinical trial agreements and internal/external processes.
• Perform clinical site qualification to ensure the staff, facilities and patient population can support the study.
• Perform site initiation, monitoring and close out visits and conduct site training and re-training during the study.
• Manage study sites to ensure enrollment is on track and data entry is timely, accurate and complete and manage. CROs to ensure the study is conducted in compliance with the protocol, GCP and the regulatory requirements.
• Conduct monitoring visits and co-monitoring visits to evaluate external CRA.
• Identify, address, and resolve issues that arise with participating clinical sites.
• Maintain the trial master file Track study enrollment and provide regular updates to study team.
• Create/coordinate creation of patient educational materials, advertisement, or other recruitment materials to support enrollment ramp-up efforts.
• Collaborate with clinical team and cross functional teams and coordinate shipment, tracking and accountability of the investigational device.
• Assist in project planning, study financial planning and invoice tracking/reconciliation, issuing payments and vendor management.
• Prepare participating clinical sites for potential inspection.
  
  
  

Education & Work Experience

• Bachelor’s degree in related field and 5 years of experience in medical device industry and clinical research or advanced degrees (Master’s, MD or PhD) with 2 years of experience in a related field or equivalent experience.
• Experience in IDE studies strongly desired.
• Extensive knowledge of FDA requirements, ICH GCP, other standards as well as medical terminology.
• Extensive knowledge of hospital, and health care environments.
• Must have high standards for quality of work.
• Good analytical thinking and problem-solving skills.
• Able to work independently and in a team environment.
• Strong sense of urgency to meet timelines and project deliverables.
• Excellent written and verbal communication skills.
• Experience interacting with physicians and research staff.
• Must be willing to travel 20 - 30%.
• Flexible, adaptable, and able to work under pressure and to meet tight timelines.
• Self-motivated and self-directed; conscientious approach to work assignments; enjoys the challenges of multitasking and working at a fast pace while staying flexible to adapt to market conditions.
  
  
  

Our salary ranges are calculated by role and level. Your position within that range will be determined by your job-related knowledge, skills, experience, relevant education, and training/certifications. In addition to those factors, we also examine internal equity as well as consider current market rate, and title may be assessed one level lower or higher accordingly. After you join the company your performance, contributions, and results along with business and organizational needs will affect your base salary. The base salary range for this full-time position is between $110,000 to $135,000 equity benefits.

NOTICE TO CANDIDATES: Please be aware that Shifamed and its portfolio companies do not conduct interviews or extend offers through mobile web chat applications. Please report any such occurrences to hr@shifamed.com.