Following an ongoing campaign, if you join PPD on a position of a
Senior CRA you will get 8000 BGN as a joining bonus!
PPD is now part of Thermo Fisher Scientific. As the world leader in
serving science, our Mission is to enable our customers to make the
world healthier, cleaner and safer. We are excited about the
opportunities this combination brings to enhance our comprehensive
end-to-end offering, enabling customers to move rapidly from
scientific idea to approved medicine
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.
Our 4i Values:
Integrity – Innovation – Intensity – Involvement
If you resonate with our 4i values above, and ultimately wish to
accelerate the delivery of safe and effective therapeutics for some
of the world’s most urgent health needs, submit your application –
we’d love to hear from you!
As we are likely to receive many applications, sometimes we are
unable to provide feedback to everyone.
Diversity Statement
PPD is proud to be an affirmative action employer that values
diversity as a strength and fosters an environment of mutual
respect. PPD is committed to providing equal employment
opportunities without regard to age, race, color, pregnancy,
national origin, religion, sex, gender identity, sexual
orientation, disability, veteran status or status within any other
protected group.
Summarized Purpose:
Performs and coordinates different 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 follow-up on findings
as applicable.
Participates in investigator meetings as necessary. May help to
identify 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
team as required. Ensures study systems are complete, accurate and
updated per agreed study conventions (e.g. Clinical Trial
Management System).
Facilitates effective communication between investigative sites,
the client company and internal project teams through written, oral
and/or electronic contacts. Responds to company, client and
applicable regulatory requirements/audits/inspections.
Maintains and 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.
