Clinical Research Associate (CRA) I/II

Company: BioCardia, Inc.
Location: Sunnyvale
Posted on: May 15, 2022

Job Description:

GENERAL INFORMATION:

Position Title: Clinical Research Associate (CRA) I/II
Department: Clinical
FLSA Status: Professional; Exempt

ORGANIZATIONAL STRUCTURE:

Reports to: Senior Clinical Research Associate or higher level
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 trialspecific
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:
- Bachelor's degree in a health care, other scientific discipline, or educational
equivalent. Alternatively, an equivalent combination of education, training and
experience may be accepted in lieu of degree.
- Qualified candidates must have at least 1-2 year of monitoring experience.
- Working knowledge of, and skill in applying, applicable clinical research
regulatory requirements (i.e., Good Clinical Practice (GCP) and International
Conference on Harmonization (ICH) guidelines).
- Preferred therapeutic area of expertise: Cardiology or related field
- Preferred 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.

Keywords: BioCardia, Inc., Sunnyvale , Clinical Research Associate (CRA) I/II, Healthcare , Sunnyvale, California