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.
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.
