(Senior) Clinical Research Associate - Study Start-up (1 year fixed-term)

Submission for the position: (Senior) Clinical Research Associate - Study Start-up (1 year fixed-term) - (Job Number: 179453)PPD’s mission is to improve health. It starts as an idea to 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 goal-driven teams combine and deliver startup activities for the clinical trials, collaborating to improve processes, cycle and flexibility. We partner with our sites, businesses and colleagues around the world to decrease startup timelines and exceed expectations.

PPD currently has an opportunity for a CRA to join our Site and Patient Access (Study Start-Up) group in Bucharest, Romania. The SSU CRA will work closely with Country Approval Specialists and Contract Specialists to prepare sites for initiation.The SSU CRA will perform and coordinate site evaluation visits in accordance with ICH GCP and FDA guidelines and global SOPs to ensure the selection of appropriately qualified sites. Developing collaborative relationshipswith investigational sites and assisting with the feasibility process.

PPD’s mission is to improve health. It starts as an idea to 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 goal-driven teams combine and deliver startup activities for the clinical trials, collaborating to improve processes, cycle and flexibility. We partner with our sites, businesses and colleagues around the world to decrease startup timelines and exceed expectations.

PPD currently has an opportunity for a CRA to join our Site and Patient Access (Study Start-Up) group in Bucharest, Romania. The SSU CRA will work closely with Country Approval Specialists and Contract Specialists to prepare sites for initiation.The SSU CRA will perform and coordinate site evaluation visits in accordance with ICH GCP and FDA guidelines and global SOPs to ensure the selection of appropriately qualified sites. Developing collaborative relationshipswith investigational sites and assisting with the feasibility process.

Education and Experience:• Bachelor’s Degree in life sciences or related field• Minimum 2 years as a clinical monitor.• Formal training in Medical Terminology• Or an equivalent combination of education and experience that provides the required knowledge, skills, and abilities to perform the job.

Knowledge, Skills and Abilities:• Excellent clinical trials monitoring skills to include conduction of qualification, initiation, monitoring and close out visits with a particular emphasis on qualification visits.• Demonstrated ability to mentor and train other monitors in a positive and effective manner.• Excellent understanding of FDA guidelines and GCPs and ability to attain and maintain a workingknowledge of applicable SOPs.• Effective organizational skills and strong attention to detail.• Effective oral and written communication skills with ability to communicate effectively with medical personnel• Excellent team player with team building skills.

At PPD we hire the best, develop ourselves and each other, and recognise the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and development programme, ensuring you reach your potential.

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 value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation but with a local feel.

- 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.#LI-TK1Education and Experience:• Bachelor’s Degree in life sciences or related field• Minimum 2 years as a clinical monitor.• Formal training in Medical Terminology• Or an equivalent combination of education and experience that provides the required knowledge, skills, and abilities to perform the job.

Knowledge, Skills and Abilities:• Excellent clinical trials monitoring skills to include conduction of qualification, initiation, monitoring and close out visits with a particular emphasis on qualification visits.• Demonstrated ability to mentor and train other monitors in a positive and effective manner.• Excellent understanding of FDA guidelines and GCPs and ability to attain and maintain a workingknowledge of applicable SOPs.• Effective organizational skills and strong attention to detail.• Effective oral and written communication skills with ability to communicate effectively with medical personnel• Excellent team player with team building skills.

At PPD we hire the best, develop ourselves and each other, and recognise the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and development programme, ensuring you reach your potential.

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 value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation but with a local feel.

- 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.#LI-TK1Submission for the position: (Senior) Clinical Research Associate - Study Start-up (1 year fixed-term) - (Job Number: 179453)