Enable America Jobs

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

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.

Position Overview:

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 apply 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. Might be assigned as a buddy during onboarding phase and provide training to new staff as needed.

Essential Functions:

• Depending on 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 relevant 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 (Asia Pac 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, study team lists, tracking of project specific training requirements, system access management and tracking of project level 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. Connects 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 raise 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 and maintain ‘accounts and contact’ information.

• Contributes to the development and roll-out of global strategic feasibility processes and standard methodologies.

• Trains new personnel in processes and systems.

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

Keys to Success:

Education and Experience:

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

Knowledge, Skills, Abilities

• Ability to work in a team or independently as required

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

• Demonstrated 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

• Proven track record 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 digital literacy, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems

• Ability to optimally complete the organizations clinical training program

• Self-motivated, positive attitude and good interpersonal skills

• Effective oral and written communication skills

• Advanced interpersonal skills

• Crucial judgment and decision-making skills

• Capable of accurately following project work instructions

• Good negotiation skills

• Independent thinker

• Ability to handle risk and perform risk escalation appropriately

Why Join Us?

We hire the best, develop ourselves and each other, and recognize the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore you will benefit from an award-winning learning and development programme (https://www.ppdi.com/careers/about#Training) , ensuring you reach your potential.

What We Offer:

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 (https://www.ppdi.com/careers/life-at-ppd) , where PPD® clinical research services 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 organization but with a local feel.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.