Clinical Research Associate (CRA) I/II
Company: BioCardia, Inc.
Posted on: May 15, 2022
Position Title: Clinical Research Associate (CRA) I/II
FLSA Status: Professional; Exempt
Reports to: Senior Clinical Research Associate or higher level
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
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
- Manage Trial Master File (TMF), site payments and regulatory
assigned clinical sites.
- Ensure all regulatory documents and study supplies are maintained
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
for assigned clinical sites.
- Track device accountability logs, shipping information, and
supplies are available at assigned clinical sites.
- Participate in the development, review and tracking of critical
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)
quality and completeness of clinical trial documentation.
- Attain thorough understanding of study management tasks and
necessary to implement compliance with protocol/regulatory
- Design data collection forms, known as case report forms
- Manage regulatory authority applications and approvals that
- 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
each center has the trial materials, and assisting with training
the site staff to trialspecific
- Ensure compliance with applicable regulations/standards,
including but not limited
to FDA regulations, ISO 14155, European Medical Device and
- Support Clinical team with investigative site contracts and
budget negotiations as
- Assist with performing site visits to meet the site team and
assess the site.
- Ensure understanding of assigned protocol (s) and trial specific
ensure quality and deliverables are met across assigned sites.
- Perform other duties as assigned.
Education and/or Job Experience:
- Bachelor's degree in a health care, other scientific discipline,
equivalent. Alternatively, an equivalent combination of education,
experience may be accepted in lieu of degree.
- Qualified candidates must have at least 1-2 year of monitoring
- Working knowledge of, and skill in applying, applicable clinical
regulatory requirements (i.e., Good Clinical Practice (GCP) and
Conference on Harmonization (ICH) guidelines).
- Preferred therapeutic area of expertise: Cardiology or related
- Preferred 2 years of directly related experience with site
management and logistical
execution of clinical trials within a medical device,
CRO and/or healthcare setting required.
- Demonstrated ability to read, analyze and interpret complex
- Demonstrated proficient written and oral communication skills in
- Proven ability to respond effectively to sensitive inquires or
Special Skills, Abilities, and Requirements:
- Proficient in software applications such as Word, Excel and
meticulous attention to detail required.
- Proven excellent database skills are required with appropriate
- Physical demands: While performing the duties of this Job, the
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.
abilities required by this job include close vision and ability to
adjust focus for near
reading, viewing computer screen, reading written documents,
- 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;
orientation to profitability; demonstrates knowledge of market and
aligns work with strategic goals.
- Change Management: Develops workable implementation plans;
changes effectively; builds commitment and overcomes resistance;
supports those affected by change; monitors transition and
- Cost Consciousness: Develops and implements cost saving measures;
to profits and revenue; conserves organization resources.
- Diversity: Demonstrates knowledge of EEO policy; shows respect
for cultural differences; educates others on the value of
diversity; promotes a
harassment-free environment; builds a diverse and cohesive
- Ethics: Sets high standard for integrity and ethical conduct for
self and the
organization. Conducts business in a manner that safeguards the
reputation for integrity and ethical conduct. Upholds organization
actual or potential conflicts of interest. Treats people with
- 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;
actions and opinions of others; accepts feedback from others; gives
recognition to others.
- Safety and Security: Observes safety and security procedures;
appropriate action beyond guidelines; reports potentially unsafe
equipment and materials properly.
Keywords: BioCardia, Inc., Sunnyvale , Clinical Research Associate (CRA) I/II, Healthcare , Sunnyvale, California
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