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PPD · Westhaven, Auckland, New Zealand

Clinical Research Associate in Auckland

CRA I/II/SCRA/Principal CRA -

Homebased anywhere in New Zealand
PPD · Westhaven, Auckland, New Zealand
1 week ago · 119 applicants

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Job Description

PPD’s mission is to improve health. It starts as an

idea to find a cure. It becomes a life saved. All in-
between, it’s you! We know that meaningful results
not only require the right approach, but also the
right people. We invite you to re-imagine health
promoting protocols with us, working alongside our
talented, bright and energetic teams.

Our global Clinical department consists of

colleagues with institutional knowledge, in-depth
therapeutic experience, and robust operational
tools. Together, we help clients define and develop
clinical programs, minimize delays and execute high-
quality, cost-efficient clinical studies.

As a PPD CRA, you will perform and coordinate all

aspects of the clinical monitoring and site
management process.

At PPD we hire the best, develop ourselves and each

other, and recognize the power of being one team.
We offer continued career advancement
opportunities, award winning training and benefits
focused on the health and wellbeing of our
employees.

Summarized Purpose

Performs and coordinates all aspects of the clinical

monitoring and site management process. Conducts
remote or on-site visits to assess protocol and
regulatory compliance and manages required
documentation. Manages procedures and guidelines
from different sponsors and/or monitoring
environments (i.e. FSO, FSP, Government, etc.). Acts
as a site processes specialist, ensuring that the trial
is conducted in accordance with the approved
protocol, ICH-GCP guidelines, applicable regulations
and SOPs to guarantee subjects rights, well-being
and data reliability. Ensures audit readiness.
Develops collaborative relationships with
investigational sites. Detailed tasks and
responsibilities assigned to role are outlined in the
task matrix.

Essential Functions

Monitors investigator sites with a risk-based

monitoring approach: applies root cause analysis
(RCA), critical thinking and problem-solving skills
to identify site processes failure and
corrective/preventive actions to bring the site into
compliance and decrease risks. Ensures data
accuracy through SDR, SDV and CRF review as
applicable through on-site and remote monitoring
activities. Assess investigational product through
physical inventory and records review.
Documents observations in reports and letters in
a timely manner using approved business writing
standards. Escalates observed deficiencies and
issues to clinical management expeditiously and
follow all issues through to resolution. May need
to maintain regular contact between monitoring
visits with investigative sites to confirm that the
protocol is being followed, that previously
identified issues are being resolved and that the
data is being recorded in a timely manner.
Conducts monitoring tasks in accordance with
the approved monitoring plan. Participates in the
investigator payment process. Ensures a shared
responsibility with other project team members
on issues/findings resolution. Investigates and
follows-up on findings as applicable.
Participates in investigator meetings as
necessary. Identifies potential investigators in
collaboration with the client company to ensure
the acceptability of qualified investigative sites.
Initiates clinical trial sites according to the
relevant procedures to ensure compliance with
the protocol and regulatory and ICH GCP
obligations, making recommendations where
warranted. Performs trial close out and retrieval
of trial materials.
Ensures that required essential documents are
complete and in place, according to ICH-GCP and
applicable regulations. Conducts on-site file
reviews as per project specifications.
Provides trial status tracking and progress update
reports to the Clinical Team Manager (CTM) as
required. Ensures study systems are updated per
agreed study conventions (e.g. Clinical Trial
Management System).
Facilitates effective communication between
investigative sites, the client company and the
PPD project team through written, oral and/or
electronic contacts.
Responds to company, client and applicable
regulatory requirements/audits/inspections.
Maintains & completes administrative tasks such
as expense reports and timesheets in a timely
manner.
Contributes to the project team by assisting in
preparation of project publications/tools and
sharing ideas/suggestions with team members.
Contributes to other project work and initiatives
for process improvement, as required.
Job Qualification

Education And Experience

Bachelor's degree in a life sciences related field or a

Registered Nursing certification or equivalent and
relevant formal academic / vocational qualification.

Previous experience that provides the knowledge,

skills, and abilities to perform the job (comparable to
1 years as a clinical research monitor) or completion
of PPD Drug Development Fellowship.

Valid driver's license where applicable.

In some cases an equivalency, consisting of a

combination of appropriate education, training
and/or directly related experience, will be
considered sufficient for an individual to meet the
requirements of the role.

Knowledge, Skills And Abilities

Proven clinical monitoring skills

Demonstrated understanding of
medical/therapeutic area knowledge and medical
terminology
Demonstrated ability to attain and maintain a
working knowledge of ICH GCPs, applicable
regulations and procedural documents
Well-developed critical thinking skills, including
but not limited to: critical mindset, in-depth
investigation for appropriate root cause analysis
and problem solving
Ability to manage Risk Based Monitoring
concepts and processes
Good oral and written communication skills, with
the ability to communicate effectively with
medical personnel
Ability to maintain customer focus through the
utilization of good listening skills, attention to
detail and the ability to perceive customers’
underlying issues
Good organizational and time management skills
Effective interpersonal skills
Attention to detail
Ability to remain flexible and adaptable in a wide
range of scenarios
Ability to work in a team or independently as
require
Good computer skills: solid knowledge of
Microsoft Office and the ability to learn
appropriate software
Good English language and grammar skills
Good presentation skills
Working Environment

PPD values the health and wellbeing of our

employees. We support and encourage individuals
to create a healthy and balanced environment where
they can thrive. Below is listed the working
environment/requirements for this role:

Able to communicate, receive, and understand

information and ideas with diverse groups of people
in a comprehensible and reasonable manner.

Able to work upright and stationary for typical

working hours.

Able to work in non-traditional work environments.

Able to use and learn standard office equipment and

technology with proficiency.

Able to perform successfully under pressure while

prioritizing and handling multiple projects or
activities.

May have exposure to potentially hazardous

elements typically found in healthcare or laboratory
environments.

This role requires independent travel up to 80%,

inclusive of traveling in automobiles, airplanes, and
trains.

PPD Defining Principles

- We have a strong will to win - We earn our

customer’s trust - We are gamechangers - We do
the right thing - We are one PPD -

If you resonate with our five principles above, and

ultimately wish to accelerate the delivery of safe and
effective therapeutics for some of the world’s most
urgent health needs, then please submit your
application – we’d love to hear from you.

PPD New Zealand requires new employees who are

in site facing roles to be fully vaccinated for COVID-
19 prior to their first working day with PPD New
Zealand. Site facing roles means employees in a role
that requires attendance at investigator sites as part
of their role; Clinical Trial Coordinator, Remote Site
Monitor, Clinical Research Associate, Clinical
Manager. Employees attending client sites may also
need to show evidence of COVID-19 vaccination to
gain access to client facilities, depending on the
client’s policy.

Accordingly, candidates must produce evidence that

they are fully vaccinated against COVID-19 (or hold
medical evidence to PPD’s satisfaction of an
accepted clinical contraindication to receiving
COVID-19 vaccinations). Ongoing evidence of
booster shots (or an applicable exemption) may also
be required during employment.

Show less

Seniority level
Not Applicable

Employment type
Full-time

Job function
Research, Analyst, and Information Technology

Industries
Research Services, Biotechnology Research, and
Pharmaceutical Manufacturing

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