Our global Clinical Operations colleagues within our PPD® clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts. Together, we help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies.

Discover Impactful Work:

Provides administrative and technical support to the Project Team. Supports audit readiness by ensuring files are reviewed according to the schedule detailed in the organization's SOP and department guidance document. Provides administrative support for site activation activities. Aids the development of the critical path for site activation within assigned projects in support of rapid site activations. Represents CRG personnel. May use local knowledge, organization systems, external site lists and sponsor directives to develop and review site lists that are suitable for the strategic needs of feasibility activities and to provide local input into the site tiering process. May act as a buddy during onboarding phase and provide training to new staff as needed.

A day in the Life:

• According to the specific role (Central or Local), coordinates, oversees and completes functions on assigned trial(s) activities as detailed on the task matrix.

• Performs department, Internal, Country and Investigator file reviews as assigned, and documents findings in appropriate system(s).

• Ensures allocated tasks are performed on time, within budget and to a high- quality standard. Proactively communicates any risks to project leads.

• Provides system support (i.e., Activate & eTMF) and ensures system databases are always current.

• Performs administrative tasks on assigned trials, including, but not limited to, timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, distributing mass mailings and communications as needed, providing documents and reports to internal team members.
• Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation.

• Assists with coordination, compilation and distribution of Investigator Site File
(ISF) and Pharmacy binder materials and non-clinical study supplies to sites.

• Assists with study-specific translation materials and translation QC upon request.

• Maintains knowledge of and understands SOPs, client SOPs/directives, and current regulatory guidelines as applicable to services provided.

• Where applicable, conducts on-site feasibility visits (APAC only).

• May support scheduling of client and/or internal meetings.

• May review and track of local regulatory documents.

• May provide system support (i.e., Activate & eTMF).

• May support RBM activities.

• May support the maintenance of study specific documentation and systems, including, but not limited to, study team lists, tracking of project specific training requirements, system access management and activity plans in appropriate system(s).

• Transmits documents to client and centralized IRB/IEC.

• Maintains vendor trackers.

• Supports start-up team in Regulatory submissions.

• Works directly with sites to obtain documents related to site selection.

• Assists the project team with the preparation of regulatory compliance review packages.

• Provides support as needed to coordinate with internal departments, ensuring site start-tup activities within the site activation critical path are aligned.

• May complete the 'Site Interest Plan' in CTMS and collection and delivery of
associated documents from investigators and site personnel.

• Documents in real time all communication, attempts a follow up associated with site contact and survey responses.

• Supports the review of survey data to ensure responses are logical, complete and reflective of the question asked.

• Works in collaboration with teammates to achieve targeted deadlines for assigned projects. Communicate with the team and appropriate clinical personnel regarding site issues and risks.
• Ensures an efficient, effective plan is in place for site contact and follow up.
Ensure compliance with the plan and escalate concerns/non-compliance to management.

• May act as the local expert regarding site capacity and experience.

• Work with key local personnel to gather knowledge base and recommend additional sites.

• Harness this knowledge base when performing local tiering of sites.

• Liaises with Global Investigator Services to resolve investigator queries in real
time and maintain 'accounts and contact' information.

• Contributes to the development and roll-out of global strategic feasibility processes and best practices.

• Trains new personnel in processes and systems.

• Utilizes local knowledge to contribute to the identification and development of new sites.

Keys to Success:

Education:

• High / Secondary school diploma or equivalent and relevant formal academic /vocational qualification. Bachelor's degree preferred.

Experience

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 1 year).

• 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.

Requirement knowledge of SSU/Regulatory processes.

Knowledge, Skills, Abilities

• Ability to work in a team or independently as required

• Good organizational skills and strong attention to detail, with shown ability to handle multiple tasks efficiently and effectively

• Shown ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency

• Strong customer focus

• Flexibility to reprioritize workload to meet changing project timelines

• Demonstrated ability to attain and maintain a good working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and
organization/Client SOPs and WPDs for all non-clinical/clinical aspects of project implementation, execution and closeout

• Good English language and grammar skills and proficient local language skills as needed

• Good computer skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems

• Ability to successfully complete the organizations clinical training program

• Self-motivated, positive attitude and good social skills

• Effective oral and written communication skills

• Good social skills

• Essential judgment and decision-making skills

• Capable of accurately following project work instructions

• Good negotiation skills

• Independent thinker

• Ability to lead risk and perform risk escalation appropriately

Working Environment

Thermo Fisher Scientific 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.

• Ability to use and learn standard office equipment and technology with proficiency.

• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

• May require travel. (Recruiter will provide more details.)

#CRAdrive

This position is remote

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
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