PPD’s mission is to improve health. It starts as an idea to find a 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 global Clinical department consists of colleagues with institutional knowledge, in-depth therapeutic experience, and robust operational tools. Together, we help clients define and develop clinical programs, minimize delays and execute high-quality, cost-efficient clinical studies.
At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.
As an SIA-CRA, your role involves a Clinical Research Associate (CRA) and Country Approval (submission) Specialist blended role.
Candidate will be expected to conduct remote or on-site Pre-Study Visits within the APAC region according to protocol requirement, regulatory compliance and manage the required documentation. This may include but not limited to:-
Identifies potential invetsigators in collaboration with the client company to ensure acceptabilit of qualified investigative sites.
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.
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.
Candidate will also coordinate with internal functional departments to ensure various site start-up activities are aligned to mutually agreed upon timelines and strategies; to drive the country/site activation according to PPD and/or client’s SOPs. These activities may include:
- Prepares, reviews and coordinates the EC (Ethics) and RA (MOH/Country) submissions
- Develops country and site-specific Patient Information Sheet/Informed Consent form documents
- Assists with grant budgets(s) and payment schedules negotiations with sites
- Achieves PPD’s target cycle times for site.
- Ensures the local country study files and filing processes are set up and maintained as per PPD WPDs or applicable client SOPs
- Develops collaborative relationships with investigational sites.
- Detailed tasks and responsibilities assigned to role are outlined in the task matrix.
Bachelor's degree in a life sciences related field or 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.
license where applicable.
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:
- 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, 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 require
- Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software
- Good English language and grammar skills
- Good presentation skills
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:
Able to communicate,
receive, and understand information and ideas with diverse groups of people in a
comprehensible and reasonable manner.
Able to work upright
and stationary for typical working hours.
Able to work in
non-traditional work environments.
Able to use and learn
standard office equipment and technology with proficiency.
Able to perform
successfully under pressure while prioritizing and handling multiple projects or
May have exposure to
potentially hazardous elements typically found in healthcare or laboratory
This role requires independent travel up to 80%, inclusive of traveling in automobiles, airplanes, and trains.
PPD Defining Principles:
- 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.