Careers

We realize that our success as a company depends on the experience, talents and hard work of our team members. 

 Our Values
  • Our mission is to develop and enhance therapies to treat cardiovascular diseases. Our number one priority is patient safety.
  • We care deeply, work fearlessly, and change lives. We take the responsibility of the trust physicians and their patients place in us seriously and it is something that we earn each and every day.
  • We work with a sense of urgency in a competitive world with limited resources at our disposal. We understand that time is money. We plan and iterate our plans continuously to enhance our efficiency and focus. We encourage brainstorming, but execution of plans are rewarded.
  • We are data driven and challenge assumptions. We address the elephants in the room. We admit our mistakes and share lessons learned. We preserve the right to change our mind. We are persistently curious and humbled by what there is left to learn. We communicate with passion and clarity.
  • We seek to contribute to and own technological advances, product designs, and the relationships with our customers writ broadly.
  • We expect and strive to inspire the best in everyone in mind, body, and soul. We value our relationships and are positive, respectful, and open minded. We recognize the importance of family. We provide service and support to our communities as an organization and as individuals.
  • We celebrate our accomplishments regularly and aim to have fun every day!


Current Openings

BioCardia is currently seeking to fill the following positions:  

Position Title:  Clinical Trial Specialist

Department:  Clinical

FLSA Status:  Professional; Exempt

ORGANIZATIONAL STRUCTURE:

Reports to:  Clinical Trial Manager level or higher

Supervises: N/A

PURPOSE OF JOB:

Responsible for the execution and support of clinical trials and regulatory submissions that are consistent with the overall business goals worldwide.  Duties will be carried out under the supervision of a Clinical Trial Manager or higher level. 

 MAJOR DUTIES AND RESPONSIBILITIES:

  • Manage Trial Master File (TMF), site payments and regulatory documents.
  • Ensure all regulatory documents and study supplies are maintained during the lifecycle of any assigned project in collaboration with the assigned field CRA(s).
  • Perform ongoing reviews of TMF to assure quality of the documentation files and compliance with BioCardia SOP, GCP and ICH Guidelines.
  • Prepare and review various study-related tracking systems to determine and report status of clinical trial documents (i.e., distribution, status, and retrieval)
  • Responsible for the follow-up to collect outstanding and replace expired documents.
  • Track device accountability logs, shipping information, and work with operations to ensure adequate supplies and investigational devices are available at clinical sites.
  • Track clinical cases and work closely with accounting to enable timely invoicing of clinical procedures.
  • Prepare clinical study binder materials (subject, regulatory, reference, and device accountability binders) and ensure timely shipment to clinical sites
  • Maintain study documentation and correspondence.
  • Assist the project team in preparation for audits/inspections. May collaborate with field CRA and/or Lead CRA to address Corrective Action Plans (CAP) and ensure quality and completeness of clinical trial documentation. 
  • Attain thorough understanding of study management tasks and responsibilities necessary to implement compliance with protocol/regulatory requirements and BioCardia SOPs.
  • Design data collection forms, known as case report forms (CRFs).
  • Support setting up of trial sites for executing the study, which includes ensuring each center has the trial materials, and assisting with training the site staff to trial-specific industry standards.
  • Ensure compliance with applicable regulations/standards, including but not limited to FDA regulations, ISO 14155, European Medical Device and Canadian regulations.
  • Support Clinical team with investigative site contracts and budget negotiations as required.
  • Ensure understanding of assigned protocol(s) and trial specific manuals/plans to ensure quality and deliverables are met across clinical sites.
  • Perform other duties as assigned. 

 
QUALIFICATIONS:

Education and/or Job Experience:

  • BS degree in relevant life science discipline required.
  • No fewer than two (2) years of directly related experience with site management and logistical execution of clinical trials within a medical device, pharmaceutical, biotechnology, CRO and/or healthcare setting required.

Communication Skills:

  • Demonstrated ability to read, analyze and interpret complex documents.
  • Demonstrated proficient written and oral communication skills in English.
  • Proven ability to respond effectively to sensitive inquiries or complaints. 

 
Special Skills, Abilities, and Requirements:

  • Proficient in software applications such as Word, Excel and PowerPoint and meticulous attention to detail required. 
  • Proven excellent database skills are required with appropriate training.
  • Physical demands:  While performing the duties of this Job, the employee is regularly required to sit in front of a computer up to 80% of the time; the employee is required to stand; walk; sit, use hands to enter data in a PC, take notes, and talk or hear.  The employee is occasionally required to reach with hands and arms.  The employee may occasionally lift and/or move up to 25 points.  Specific vision abilities required by this job include close vision and ability to adjust focus for near reading, viewing computer screen, reading written documents, etc. 

Nice to Haves / Areas for Growth:

  • Experience with cardiovascular trials preferred.
  • Experience with eTMF systems such as Florence preferred.
  • Experience with legal administrative tasks preferred.
  • Business Acumen: Understands business implications of decisions; displays orientation to profitability; demonstrates knowledge of market and competition; aligns work with strategic goals.
  • Change Management: Develops workable implementation plans; communicates changes effectively; builds commitment and overcomes resistance; prepares and supports those affected by change; monitors transition and evaluates results.
  • Cost Consciousness:  Develops and implements cost saving measures; contributes to profits and revenue; conserves organization resources.
  • Diversity: Demonstrates knowledge of EEO policy; shows respect and sensitivity for cultural differences; educates others on the value of diversity; promotes a harassment-free environment; builds a diverse and cohesive workforce.
  • Ethics: Sets high standard for integrity and ethical conduct for self and the organization.  Conducts business in a manner that safeguards the Company’s reputation for integrity and ethical conduct.  Upholds organization values.  Avoids actual or potential conflicts of interest.  Treats people with respect. 
  • Initiative:  Takes independent actions and calculated risks; looks for and takes advantage of opportunities; seeks increased responsibilities; asks for and offers help when needed. 
  • Leadership: Inspires and motivates others to perform well; effectively influences actions and opinions of others; accepts feedback from others; gives appropriate recognition to others.
  • Safety and Security:  Observes safety and security procedures; determines appropriate action beyond guidelines; reports potentially unsafe conditions; uses equipment and materials properly


------------------------------------------------------------------------

Position Title:  Clinical Research Associate (CRA) I/II

Department:  Clinical

FLSA Status:  Professional; Exempt

ORGANIZATIONAL STRUCTURE:

Reports to:  Senior Clinical Research Associate level or higher

Supervises: N/A

PURPOSE OF JOB:

 Responsible for the execution and support of clinical trials and regulatory submissions that are consistent with the overall business goals worldwide.  Duties will be carried out under the supervision of a Senior Clinical Research Associate or higher level. 

MAJOR DUTIES AND RESPONSIBILITIES:

  • Responsible for study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits.
  • Maintain study documentation and correspondence for assigned clinical sites.
  • Manage Trial Master File (TMF), site payments and regulatory documents for assigned clinical sites.
  • Ensure all regulatory documents and study supplies are maintained during the lifecycle of any assigned project in collaboration with the assigned field CRA for assigned clinical sites.
  • Perform ongoing reviews of TMF to assure quality of the documentation files and compliance with BioCardia SOP, GCP and ICH Guidelines.
  • Ensure study-related tracking systems are kept up to date to determine and report status of clinical trial documents (i.e., distribution, status, and retrieval of study documents) for assigned clinical sites.
  • Responsible for the follow-up to collect outstanding and replace expired documents for assigned clinical sites.
  • Track device accountability logs, shipping information, and ensure adequate supplies are available at assigned clinical sites.
  • Participate in the development, review and tracking of critical study documents such as informed consent form templates
  • Assist the project team in preparation for audits/inspections. May collaborate with field CRA and/or Lead CRA to address Corrective Action Plans (CAP) and ensure quality and completeness of clinical trial documentation. 
  • Attain thorough understanding of study management tasks and responsibilities necessary to implement compliance with protocol/regulatory requirements and BioCardia SOPs.
  • Design data collection forms, known as case report forms (CRFs).
  • Manage regulatory authority applications and approvals that oversee research.
  • Support the identification / selection of an investigator who will be responsible for the conduct of the trial at the trial site.
  • Support the identification and assessment of the suitability of facilities to be used as the clinical trial site.
  • Support setting up of trial sites for executing the study, which includes ensuring each center has the trial materials, and assisting with training the site staff to trial-specific industry standards.
  • Ensure compliance with applicable regulations/standards, including but not limited to FDA regulations, ISO 14155, European Medical Device and Canadian regulations.
  • Support Clinical team with investigative site contracts and budget negotiations as required.
  • Assist with performing site visits to meet the site team and assess the site.
  • Ensure understanding of assigned protocol (s) and trial specific manuals/plans to ensure quality and deliverables are met across assigned sites.
  • Perform other duties as assigned. 

 QUALIFICATIONS:

 Education and/or Job Experience:

  • BS degree in relevant life science discipline required.
  • No fewer than two (2) years of directly related experience with site management and logistical execution of clinical trials within a medical device, pharmaceutical, biotechnology, CRO and/or healthcare setting required.

Communication Skills:

  • Demonstrated ability to read, analyze and interpret complex documents.
  • Demonstrated proficient written and oral communication skills in English.
  • Proven ability to respond effectively to sensitive inquires or complaints. 

 Special Skills, Abilities, and Requirements:

  • Proficient in software applications such as Word, Excel and PowerPoint and meticulous attention to detail required. 
  • Proven excellent database skills are required with appropriate training.
  • Physical demands:  While performing the duties of this Job, the employee is regularly required to sit in front of a computer up to 80% of the time; the employee is required to stand; walk; sit, use hands to enter data in a PC, take notes, and talk or hear.  The employee is occasionally required to reach with hands and arms.  The employee may occasionally lift and/or move up to 25 points.  Specific vision abilities required by this job include close vision and ability to adjust focus for near reading, viewing computer screen, reading written documents, etc. 
  • Experience with US and international studies a plus.
  • This position may require up to 20-80% travel time.

Nice to Haves / Areas for Growth:

  • Experience with cardiovascular trials preferred.
  • Experience with eTMF systems such as Florence preferred.
  • Experience with legal administrative tasks preferred.
  • Business Acumen: Understands business implications of decisions; displays orientation to profitability; demonstrates knowledge of market and competition; aligns work with strategic goals.
  • Change Management: Develops workable implementation plans; communicates changes effectively; builds commitment and overcomes resistance; prepares and supports those affected by change; monitors transition and evaluates results.
  • Cost Consciousness:  Develops and implements cost saving measures; contributes to profits and revenue; conserves organization resources.
  • Diversity: Demonstrates knowledge of EEO policy; shows respect and sensitivity for cultural differences; educates others on the value of diversity; promotes a harassment-free environment; builds a diverse and cohesive workforce.
  • Ethics: Sets high standard for integrity and ethical conduct for self and the organization.  Conducts business in a manner that safeguards the Company’s reputation for integrity and ethical conduct.  Upholds organization values.  Avoids actual or potential conflicts of interest.  Treats people with respect. 
  • Initiative:  Takes independent actions and calculated risks; looks for and takes advantage of opportunities; seeks increased responsibilities; asks for and offers help when needed. 
  • Leadership: Inspires and motivates others to perform well; effectively influences actions and opinions of others; accepts feedback from others; gives appropriate recognition to others.
  • Safety and Security:  Observes safety and security procedures; determines appropriate action beyond guidelines; reports potentially unsafe conditions; uses equipment and materials properly. 

News


Have questions?
CALL US NOW
: (800) 624-1179
Have questions?
EMAIL US NOW
: info@biocardia.com

biocardia takes a new and comprehensive
approach to heart failure

By introducing patient screening and highly-efficient delivery to stem cell therapy, the company seeks to increase the likelihood of treatment success, enabling more patients to return to the things they love.