Summarized Purpose:
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 utilize 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.
Essential Functions:
- 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 highquality 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, including, but not limited to, 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 and 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.
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 and 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
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 nonclinical/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 interpersonal skills
Effective oral and written communication skills
Good interpersonal skills
Essential Judgment And Decision-making Skills
Capable of accurately following project work instructions
Good negotiation skills
Independent thinker
Ability to manage risk and perform risk escalation appropriately
