We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.
Site and Patient Access is a global department working to provide rapid site activation and patient access to our clients.
Our innovative approach is designed to help save our clients time and money while driving industry-leading cycle times. Working in Site and Patient Access, you are a very important step in our commitment to industry leadership and the relentless pursuit of excellence.
Currently PPD is recruiting for SIA - Clinical Research Associate to join our Site Intelligence & Activation (SIA) department. Our goal-driven teams combine and deliver study start-up activities for clinical trials, collaborating to improve processes, cycle and flexibility. We partner with our sites, businesses and colleagues around the world to decrease start-up timelines and exceed expectations.
Essential Functions and Other Job Information:
· Provides Site Selection support for awarded multi-service projects
· Conducting the Site Selection assessments locally via communication with investigators. Conduct of country- and site-level feasibility.
· Conduct pre-study visits (PSVs), prepare PSV-reports, and provide information leading to a decision to render the site qualified or not qualified for participation in the trial.
· Achieves PPD’s target cycle times for site
· Develop and implement the local submission strategy and provides technical expertise and coordination oversight for projects in collaboration with relevant internal departments to ensure all site start-up activities are aligned with submission activities and mutually agreed upon timelines.
· Develop country and site specific Patient Information Sheet/Informed Consent form and other patient related documents as applicable.
· Ensure the submission process for sites and studies are aligned to the critical path for site activation.
- Developed collaborative relationships with investigative sites and client company personnel.
- Collection of CDA/DPA/IBI from the site, distribution of electronic (in some cases paper) feasibility to sites, CTMS entry and tracking of all Site Interest Plan documentation and associated communications; facilitation of information to the GIS representative for site creation in CTMS.
- Maintain regular site contact during the start-up phase and document all communications in CTMS.
- Collect and QC’s all trial commencement documents including essential (RCR) and non- essential (non RCR) documents and certifications.
Education and Experience:
Bachelor's degree or above
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 to 2 years') or equivalent combination of education, training, & experience.
Knowledge, Skills and Abilities:
- Effective oral and written communication skills
- Excellent interpersonal skills
- Strong attention to detail and quality of documentation
- Good negotiation skills
- Good computer skills and the ability to learn appropriate software
- Good English language and grammar skills
- Basic medical/therapeutic area and medical terminology knowledge
- Ability to work in a team environment or independently, under direction
- as required
- Basic organizational and planning skills
- Basic knowledge of all applicable regional / national country regulatory guidelines and EC regulations
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.
As we are likely to receive many applications, sometimes we are unable to provide feedback to everyone.