Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

At PPD, part of Thermo Fisher Scientific, you can have meaningful work that has a positive impact worldwide. Join us in bringing our Mission to life - helping customers create a healthier, cleaner, and safer world. We support our teams in achieving their career goals while advancing science through research, development, and delivery of life-changing therapies. Our work includes clinical trials in 100 countries and innovative approaches to clinical research in our PPD clinical research portfolio. We cover laboratory, digital, and decentralized clinical trial services. By delivering quality and accuracy, you will contribute to better health outcomes for people and communities.

This is a great opportunity for CRA's currently working within the life science sector to work with a world-leading CRO and dedicated to one of our Clients.

Essential Functions
Applies root cause analysis (RCA), critical thinking, and problem-solving skills to identify site processes failure and take corrective/preventive actions to ensure compliance and reduce risks.
Ensures data accuracy through SDR, SDV, and CRF review as applicable through on-site and remote monitoring activities.
Assesses investigational product through physical inventory and records review.
Details observations in reports and letters according to timelines using approved business writing standards.
Advances observed deficiencies and issues to clinical management expeditiously and follows all issues through to resolution.
Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution.
Participates in investigator meetings as necessary.
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.
Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations.

Education and Experience:

Life science Degree:

Understanding of ICH-GCP, EU, and FDA requirements

Proficiency in English:

Monday-Friday 09:00-17:00

Home Based – Able to visit Client’s premises 1/month and participate in events 2/year

Traveling

0-1.5 year (** if monitoring experience is more than a year a level II offer can be extended, **in case of 0 monitoring experience previous work on clinical trials field eg aCRA, Study Coordinator is mandatory)
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
Good oral and written communication skills
Ability to maintain customer focus through the utilization of good listening skills and attention to detail
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 computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software
As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD truly values a work-life balance.

Our 4i Values
Integrity – Innovation – Intensity – Involvement

If you connect with our 4i values and want to speed up the development of safe and effective therapeutics for urgent health needs, please apply.