CRA (Level II) - Customer Dedicated
(FSP) With Joining Bonus!!
Apply now!!
We¡¯re offering a 1 month¡¯s salary as a joining bonus with 1 year
clawback for all CRA (Level II) and above hires.
we believe flexibility is an expectation, not something that is earned. That¡¯s why work setting decisions here are based on individual preference and your role. We offer three work setting options designed to give you the maximum amount of flexibility your role allows – Home-based, Office-based & Flex (3 days office-based and 2 days home-based).
Who is PPD?
PPD is a leading global contract research
organization. Our purpose is to improve
health. Our mission is to help customers deliver life-changing therapies. Our
strategy is to bend the cost and time curve of drug development and optimize
value for our customers.
The PPD FSP Solution:
PPD's Functional Service Provider division partner with and
serve as an extension of our PPD team, supporting our customers key
functions. We cover customer needs on
every level, allowing them to do more with less, with an uncompromising
commitment to quality. We deploy the same top-tier talent in ALL engagement
models. Exceptionally trained, rigorously supported and technologically
empowered to help customers manage capacity and set programs up for success.
Joining within our PPD FSP functional area, allows you to
join the renowned PPD CRO and still gain invaluable client dedicated
experience.
Responsibilities:
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:
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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.
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Ensures
a shared responsibility with other project team members on issues/findings
resolution. Investigates and follows-up on findings as applicable.
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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.
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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.
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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).
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Facilitates
effective communication between investigative sites, the client company and the
PPD project team through written, oral and/or electronic contacts.
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Responds
to company, client and applicable regulatory requirements/audits/inspections.
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Maintains
& completes administrative tasks such as expense reports and timesheets in
a timely manner.
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Contributes
to the project team by assisting in preparation of project publications/tools
and sharing ideas/suggestions with team members.
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Contributes
to other project work and initiatives for process improvement, as
required.
Education and Experience:
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Bachelor's
degree in a life sciences related field or a Registered Nursing certification
or equivalent and relevant formal academic / vocational qualification.
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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.
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Valid
driver's license where applicable.
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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:
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Proven
clinical monitoring skills
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Demonstrated
understanding of medical/therapeutic area knowledge and medical
terminology
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Demonstrated
ability to attain and maintain a working knowledge of ICH GCPs, applicable
regulations and procedural documents
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Well-developed
critical thinking skills, including but not limited to: critical mindset,
in-depth investigation for appropriate root cause analysis and problem solving
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Ability
to manage Risk Based Monitoring concepts and processes
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Good
oral and written communication skills, with the ability to communicate
effectively with medical personnel
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Ability
to maintain customer focus through the utilization of good listening skills,
attention to detail and the ability to perceive customers¡¯ underlying
issues
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Good
organizational and time management skills
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Effective
interpersonal skills
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Attention
to detail
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Ability
to remain flexible and adaptable in a wide range of scenarios
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Ability
to work in a team or independently as require
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Good
computer skills: solid knowledge of Microsoft Office and the ability to learn
appropriate software
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Good
English language and grammar skills
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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:
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Able
to communicate, receive, and understand information and ideas with diverse
groups of people in a comprehensible and reasonable manner.
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Able
to work upright and stationary for typical working hours.
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Able
to work in non-traditional work environments.
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Able
to use and learn standard office equipment and technology with
proficiency.
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Able
to perform successfully under pressure while prioritizing and handling multiple
projects or activities.
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May
have exposure to potentially hazardous elements typically found in healthcare
or laboratory environments.
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This
role requires independent travel up to 80%, inclusive of traveling in
automobiles, airplanes, and trains.
PPD¢ç FSP: People Who
Deliver | PPD Careers -
Read about PPD employee experiences!