Buenos Aires, Argentina
São Paulo, Brazil
Full time
R

Job Overview

Under moderate supervision, executes the feasibility, site identification regulatory and start-up activities in accordance with regulations, SOPs, and project requirements at the regional, or country level.
Prepares and manages site documentation; reviews and negotiates site documents and contracts with sites and sponsors; maintains, reviews, and reports on site performance metrics; serves as the primary point of contact for investigative sites; tracks completion of appropriate documents for sites; ensures contracts are fully executed; and establishes project timelines.
With moderate oversight and supervision, perform tasks at a country/region level associated with site activation activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines.

May also include maintenance activities.

Essential Functions

- With moderate oversight and supervision, serve a Single Point of Contact (SPOC) to perform feasibility and site activation activities in assigned studies for investigative sites, according to applicable regulations, SOPs and work instructions, working closely with the Site Activation Manager (SAM), Project Management team, and other departments as necessary. Review documents for completeness, consistency and accuracy, under guidance of senior staff.
- Prepare site documents, reviewing for completeness and accuracy.
- Inform team members of completion of regulatory contractual. and other documents for individual sites.
- Distribute completed documents to sites and internal project team members.
- Update and maintain internal systems, databases, tracking tools, timelines and project plans with accurate and complete project specific information.
- Review, track and follow up the progress, the approval and execution of required documents such as questionnaires, CDAs, regulatory, ethics, Informed Consent Form (ICF) and Investigator Pack (IP) release documents. Requires advanced knowledge within a specific discipline typically gained through extensive work experience and/or education.

Qualifications

- Bachelor's Degree Life sciences or a related field
- At least 1 year of clinical research experience
- Advanced level of English - you'll be working with North American sites

This is a junior role, ideal for anyone with some experience that wants to pivot to the site activation role or that wants to learn new things _!_
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description

Join Us as a Clinical Trial Coordinator II - Make an Impact at the Forefront of Innovation

We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.
As part of our global team, you'll have the opportunity to provide administrative and technical support to the Project Team. As a Clinical Operations Delivery Associate II,



you'll support audit readiness by ensuring files are reviewed according to the schedule detailed in the organization’s SOP and department guidance document.

You will provide administrative support for site activation activities and aid in the development of the critical path for site activation within assigned projects to support rapid site activations.

What You'll Do:

- 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 and line manager as appropriate.
- 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.
- Reviews and tracks local regulatory documents.
- Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation.
- Maintains vendor trackers.
- 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.
- Assists with technical and administrative support for projects in collaboration with internal departments and team members.
- Maintains knowledge of and understands SOPs, client SOPs/directives, and current regulatory guidelines, as applicable to services provided.
- Ensures that trial status information relating to activities is accurately maintained in the database and current at all times.
- Where applicable, develops and maintains relationship with client local affiliates.
- Champions the inclusion of Strategic Collaboration sites into the process.
- Trains new personnel in processes and systems.
- May support the maintenance of study specific documentation and global support with specific systems, tools and trackers, including, but not limited to, study team lists, tracking of project specific training requirements, system access management for organization/vendor/clients and tracking of project level activity plans in appropriate system. Ensures (e)TMF is up to date by following file review schedules and documenting findings in appropriate system(s).
- May provide system support (i.e., Activate & eTMF).
- May support RBM activities.
- May transmit documents to client and centralized IRB/IEC.
- May attend Kick off Meeting and take notes when required.




- May support scheduling of client and/or internal meetings
- May support scheduling and organization of client and/or internal meetings with completion of related meeting minutes.
- Provides support as needed to coordinate with internal departments and ensure site start-up activities within the site activation critical path are aligned.
- Assists the project team with the preparation of regulatory compliance review packages.
- May support start-up team in Regulatory submissions.
- Occasionally works directly with site(s) to obtain documents related to site selection.
- May develop site list, including research from internal and external sources to ensure the site list is reflective of the defined site profile. Ensure current investigator and site staff contact details are appropriately maintained in company systems.
- May complete the ‘Site Interest Plan’ in CTMS and collection and delivery of associated documents from investigators and site personnel. Document 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 escalates 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. Harnesses this knowledge base when performing local tiering of sites.
- May conduct phone interviews, scripted or non-scripted, with physicians and other site personnel to discuss standard of care and obtain protocol-level input to support trial optimization projects.
- 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 integral strategic feasibility processes and best practices.

Education and Experience Requirements:

- 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 at least 2 years).

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
- Strong organizational skills and attention to detail, with proven ability to handle multiple tasks efficiently and effectively
- Proven ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency
- Strong customer focus
- … (additional bullet points retained verbatim) ...

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