Clinical Trial Associate
il y a 2 semaines
We bring a high caliber of scientific and clinical expertise to the development of drugs that address the world's most challenging health concerns.
Our Clinical Research team, who powers our PPD clinical research portfolio, are part of our leading global contract research organization (CRO).
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.
Who is PPD Clinical Research Services?PPD is a leading global contract research organization. Our purpose is to improve health. Our mission is to help customers deliver life-changing therapies. Our strategy is to bend the cost and time curve of drug development and optimize value for our customers. PPD is now part of Thermo Fisher Scientific.
As the world leader in serving science, our Mission is to enable our customers to make the world healthier, cleaner and safer.
We are excited about the opportunities this combination brings to enhance our comprehensive end-to-end offering, enabling customers to move rapidly from scientific idea to approved medicineThe PPD FSP Solution:
PPD's Functional Service Provider division partner with and serve as an extension of our PPD team, supporting our customers key functions.
We cover customer needs on every level, allowing them to do more with less, with an uncompromising commitment to quality.
We deploy the same top-tier talent in ALL engagement models. Exceptionally trained, rigorously supported and technologically empowered to help customers manage capacity and set programs up for success.
Joining within our PPD FSP functional area, allows you to join the renowned PPD CRO and still gain invaluable client dedicated experience.
- Work on Clinical Trials by assisting the Clinical Trial Manager(s) (CTM) with the conduct of the assigned clinical trial(s) (eg administration, coordination, and archiving)
- Assist with the inspection readiness of the Electronic Clinical Operations system (ECO) for their assigned trials
- Provide support to the Clinical Trial Team (CTT) (eg ECO support, training matrix, minute taking, and/or creation of trackers, system access management)
- Help the Global Head of Trial Operations with the logistics of the departmental meetings (eg minute taking)
The CTA may:
- Assist the Clinical Operations Lead (COL) with organizing the Clinical Team (CT) Meetings (agenda, meeting minutes, followup on action items)
- Support projects related to improvement/implementation of clinical processes and systems based on relevant experience
- Support onboarding of new CTAs
REPORTING LINE
- CTA Line Manager
ROLES AND RESPONSIBILITIES
- The CTA must:
- Assist the CTM and CTT with the coordination of the logístical aspects of the assigned trial(s), according to Good Clinical Practice (GCP) and the applicable Standard Operation Procedures (SOPs)
- Develop and adapt documents to trial specific requirements in collaboration with the CTM
- Assist with organizing (agenda, meeting minutes, followup on action items) trial specific meetings, including but not limited to trial team meetings and Investigator Meetings
- Coordinate the filing of the sponsor Trial Master File (TMF) documents in the (electronic) Trial Master File (TMF) part of ECO by reviewing completeness and correct use of ECO. Followup with the CTT on findings and provide support on how to use ECO.
- Act as Business Administrator in the eTMF system, by maintaining records and supporting closeout activities (including archival preparation) in the eTMF system
This includes:
managing study records, country records and site records.
- Assist the CTM/COL to ensure that the sponsor Trial Operations TMF Documents are properly filed and made ready for archiving.
- Provide logístical support to the CTT on vendor (e)TMF oversight activities
The CTA may:
- Assist the Global Head of Trial Operations with the development of department template documents and the organization of the departmental meetings (agenda, meeting minutes, followup on action items)
- Assist with the preparation of trial reports for the CT
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