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At Thermo Fisher Scientific, you’ll discover meaningful work
that makes a positive impact on a global scale. Join our colleagues in bringing
our Mission to life - enabling our customers to make the world healthier,
cleaner and safer. We provide our teams with the resources needed to achieve
individual career goals while taking science a step beyond through research,
development and delivery of life-changing therapies. With clinical trials
conducted in 100+ countries and ongoing development of novel frameworks for
clinical research through our PPD clinical research portfolio, our work spans
laboratory, digital and decentralized clinical trial services. Your
determination to deliver quality and accuracy will improve health outcomes that
people and communities depend on – now and in the future.
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 supervising
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.
Key responsibilities
? 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
supervising 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 vital. 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 crucial 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.
Keys to Success
Education and Experience:
Bachelor's degree in a life sciences related fielder 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.
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 solid
understanding 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 required.
? Good digital literacy: solid knowledge of Microsoft Office
and the ability to learn appropriate software.
? Good English language and grammar skills.
? Good presentation skills.
Benefits
We offer competitive remuneration, annual incentive plan
bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific
offers employment with an innovative, forward-thinking organization, and
outstanding career and development prospects. We offer an exciting company
culture that stands for integrity, intensity, involvement, and innovation!
Our Mission is to enable our customers to make the world
healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work
with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to
accelerate research, solve complex scientific challenges, drive technological
innovation and support patients in need. #StartYourStory with PPD, part of
Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.