Senior CRA
Company: ICON Strategic Solutions
Location: Santa Fe
Posted on: January 23, 2023
Job Description:
ICON plc is a world-leading healthcare intelligence and clinical
research organisation. From molecule to medicine, we advance
clinical research providing outsourced services to pharmaceutical,
biotechnology, medical device and government and public health
organisations. With our patients at the centre of all that we do,
we help to accelerate the development of drugs and devices that
save lives and improve quality of life. Our people are our greatest
strength, are at the core of our culture, and the driving force
behind our success. ICON people have a mission to succeed and a
passion that ensures what we do, we do well.What will you be
doing?
- Strong written and verbal communication skills in English and
local language (if applicable), good presentation, negotiation and
influencing
- Able to work within remote teams and
- Ability to effectively manage multiple priorities and
responsibilities of increasing scope and complexity.
- Good interpersonal
- Strong planning & organizational skills, and the ability to
work efficiently and effectively in a dynamic
- Respects confidentiality in terms of
- Proactive, conscientious and precise in delivery of quality
work even when under pressure
- Effective at analyzing and escalating issues at the right
functional level, solving problems and resolving conflicts in a
timely
- Flexible with high learning and change agility
- Collaborative, building strong internal and external
- Knowledge of local regulations, IND/ICH GCP - guidelines,
- Available and willing to travel as job requires
- Strong computer skills with good eye for
- Communicate the progress and relevant information or escalate
issues of the study to the appropriate study management team
- Engage and maintain good written and verbal communication with
external stakeholders in order to ensure effective study
- Accountable for local activities required in set up and for
high quality execution of studies; will seek managerial or other
experienced support as appropriate:
- Performs operational site evaluation visits, study initiation
visits, on and off-site monitoring visits at the required frequency
and site close-out
- Performs site evaluation visits:
- Determines the feasibility of the study protocol with reference
to study complexity
- Confirms staff availability, suitable clinical facilities,
potential for per protocol patient population,
- Confirms ability to comply with ICH GCP and requirements for
clinical studies.
- Works with Study staff to carry out a local study / site level
risk
- Delivers appropriate training to site staff and other relevant
parties, as required. Assists with web based and face to face
trainings to ensure that investigators and site staff are
appropriately trained in ICH GCP and study related procedures so
that they can effectively run the clinical
- Participate in global investigators and/or monitor meetings as
appropriate. Facilitates investigators participation in global
meetings and/or may assist the study staff with organizing local
investigator Participates in other study meetings as required.
- Maintain good relationship with sites and ensure that critical
study timelines related to monitoring activities are achieved and
that recruitment targets, patient recruitment cycle times, data and
audit quality and site related milestones are
- Ensure that investigators and staff fully understand their
roles and responsibilities with respect to regulatory requirements
(ICH-GCP).
- Work with the sites to ensure they address data queries in a
timely Verifying that data entered in to the CRFs is consistent
with patient medical notes and entered in real time.
- Ensure Investigator and site staff receives safety reports and
new safety information in a timely manner.
- Ensure the accuracy of data collected for safety reporting
(AEs, SAEs etc.), and provides such information to safety
department and other relevant departments, within the required time
frames.
- Completes monitoring visit reports within the agreed
- Ensure local and global clinical study tracking databases are
kept current with clinical study information as required (i.e.
e-track, Veeva, RAMOS).
- Ensure all necessary study supplies are available at sites in a
timely manner and appropriate accountability is maintained during
the study. Ensure all unused study supplies are accounted for and
destroyed appropriately.
- Ensure sponsor study records are inspection ready at all times
and archives records as applicable.What do y ou need to
have?Education required:
- Undergraduate degree or its international equivalent in
clinical, science, or health-related fieldfrom an accredited
institution; a licensed health-care professional (i.e., registered
nurse); or equivalent work experience preferredSkills Required
- Read, write and speak fluent English; fluent in host country
language required.
- 2-4 years of clinical monitoring experience required
- Knowledge of ICH and local regulatory authority regulations
regarding drug
- Clinical research experience
- Knowledge of ICH and local regulatory authority regulations
regarding drug
- Experience in monitoring all trial components (PSSV to
COV)
- Experience in coaching/mentoring other CRABenefits of Working
in ICON:Our success depends on the knowledge, capabilities and
quality of our people. Thats why we are committed to developing our
employees in a continuous learning culture one where we challenge
you with engaging work and where every experience adds to your
professional development.At ICON, our focus is to provide you with
a comprehensive and competitive total reward package that
comprises, not only an excellent level of base pay, but also a wide
range of variable pay and recognition programs. In addition, our
best in class employee benefits, supportive policies and wellbeing
initiatives are tailored to support you and your family at all
stages of your career - both now, and into the future.ICON,
including subsidiaries, is an equal opportunity and inclusive
employer and is committed to providing a workplace free of
discrimination and harassment. All qualified applicants will
receive equal consideration for employment without regard to race,
color, religion, sex, sexual orientation, gender identity, national
origin, disability or protected veteran status.If, because of a
medical condition or disability, you need a reasonable
accommodation for any part of the application process, or in order
to perform the essential functions of a position, please let us
know.
Keywords: ICON Strategic Solutions, Santa Fe , Senior CRA, Other , Santa Fe, New Mexico
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