1 Staff Clinical Research Associate, Adona Medical Job in Los Gatos, CA

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Staff Clinical Research Associate, Adona Medical

Shifamed LLC

Los Gatos, CA | Full Time

$80k-105k (estimate)

3 Months Ago

Staff Clinical Research Associate, Adona Medical

Shifamed LLC Los Gatos, CA

$80k-105k (estimate)

Full Time 3 Months Ago

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Shifamed LLC is Hiring a Staff Clinical Research Associate, Adona Medical Near Los Gatos, CA

Adona Medical, a Shifamed Portfolio Company, is focused on innovating interventional approaches for heart failure, a complex and progressive condition. Heart failure is a progressive condition that impacts approximately 6.5 million patients in the United States and as many as 26 million patients globally. To learn more about Adona Medical, please visit https://www.adonamed.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 Staff CRA is responsible for the day-to-day management of clinical sites in support of global clinical trials, as required. They will be accountable for project management activities, oversight of multiple vendors and for conducting clinical studies in compliance with applicable clinical and regulatory standards and in alignment with the business needs. This individual is responsible for interfacing with, supporting the clinical studies at clinical sites. Responsibilities include and are not limited to site start-up, overall study management, data management, monitoring oversight, CRO/vendor management, device accountability management and other site/study logistics. Additional activities include site interfacing to ensure timely patient scheduling for key trial follow-up endpoints, interfacing and supporting regulatory submissions as needed.

Responsibilities, Skills & Hands-On Experience

Serve as a crucial member of the clinical study team and will be accountable for overall study/site management activities, interface with external vendors – as required.
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 manage site start-up activities and support participating sites with IRB/EC preparation and submission.
Manage clinical trial agreements and internal/external processes.
Conducts sponsor oversight visits and may conduct site qualification / initiation visits.
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 co-monitoring visits to evaluate external CRA.
Participate in identifying, addressing, and resolving issues that arise with participating clinical sites.
Maintain the trial master file via electronic trial master file platform.
Track study enrollment and provide regular updates to study team.
Collaborate with clinical team and cross functional teams and coordinate shipment, tracking and accountability of the investigational device.
Assist in project planning, 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 8 years of experience in medical device industry and clinical research or advanced degrees (Master’s, MD or PhD) with 4 years of experience in a related field or equivalent experience.
Experience in IDE studies involving class 3 cardiovascular devices is strongly desired.
Extensive knowledge of FDA requirements, ICH GCP, other standards as well as medical terminology.
Must have high standards for quality of work.
Good analytical thinking and problem-solving skills.
Strong sense of urgency to meet timelines and project deliverables.
Excellent written and verbal communication skills.
Experience interacting with research staff at clinical study sites/hospitals.
Must be willing to travel 10 - 20%.
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 $140,000 to $170,000 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.