Senior Initiation Clinical Research Associate (iCRA) - FSP

Parexel FSP is looking for Senior iCRAs in Argentina, Brazil and Mexico!

Summary

Responsible for ensuring the completeness of Site Essential Document Packages as well as the Site Regulatory Packages (SRP) required to achieve site initiation and activation status.  This also includes the renewal of critical essential documents in the event of protocol amendments introduced during the Final Approved Protocol to Last Patient, First Visit. Areas of additional responsibility include the tracking of document translations requirements, site SRP reviews and approvals, and required training activities.  
Will ensure the clinical study insurance documents are current and filed in the electronic Trial Master File (TMF) from the beginning of the study until study completion in compliance with SOPs and guidance.
Introduces specialized industry-leading and/or emerging concepts to develop innovative business solutions. Serves as an advisor, mentor, internal consultant, and/or helps drive new initiatives
Additionally, may serve as the primary contact for acquiring insurance documents on behalf of the clinical study team.  May serve as the main liaison between Client/CRO and the insurance broker/carrier.  The Associate Manager Clinical Documentation – May ensure the clinical study insurance documents are current and filed in the electronic Trial Master File (TMF) from the beginning of the study until study completion in compliance with SOPs and guidance.  

Responsibilities

Site Initiation and Regulatory Packages

• Gathers all documents required for the purposes of enabling Site Initiation; includes the compilation of documents from multiple internal stakeholders and supporting functions to then distribute to the site in a structured and time sensitive manner.

• Identifies and tracks documents that require translations/linguistic validations and works with translation support services to define the scope of work and critical timelines for deliverables.         

Study Investigator Site Essential Document Oversight

• Serves as study expert on investigator site essential documentation

• Develop and maintain sponsor's documentation of expectations / standards of investigator site essential documentation

• Provide training to internal and external study teams on the expectations / standards of investigator site essential documentation

• Review investigator site essential documentation packages from CROs per process and sample as needed

• May collaborate directly with sites regarding collection of documents and IRB timelines for site activation and ensure that relevant documents are uploaded into the eTMF.

• Collect study specific metrics and feedback and provide to internal and external study teams (including CRO partners) and sponsor's management as required.

• Assists in inspection readiness activities in relation to site start up documents

• Participates in lessons learned opportunities to retrain study teams and CROs understand what has worked or not to prevent repeating past mistakes.

Study Team Interaction

• May represent Site Start up on cross-functional study team (s) and/or sub-team(s); Attends Kick Off meetings to present SSU Roles and Responsibilities

• Works with and provides status to study team to ensure essential documentation packages are approved for initial drug shipments according to study timelines. Supports Clinical Study team in ensuring regulatory documents are submission and audit ready Escalates as necessary

• Collaborates with CRO and internal team to ensure timely feedback / resolution of document issues

• Provides support for overall study and site timelines and milestone projections

• Management of investigator and Site usability and due diligence checks

• Supports deliverables for site initiation and activation

Additionally, for assigned studies in the EU region:

• Engage with Regulatory Affairs functional representatives to plan the Clinical Trial Application (CTA) for any one up and coming clinical trial that involves EU countries

• Engage with Clinical Trial Management functional representatives to determine key study milestones and country allocation strategies

• Coordinate with Clinical Transparency regarding any redactions required for relevant documents identified for CTA submissions

• Identify the list of Member State/countries participating in any one clinical trial and capture the information within the CTIS database

• Identify the key study level and Member State/country level milestones that represent Study Start, Study Completion, Enrollment Start, Enrollment Completion and any potential hold/restart/cancel dates that may apply to the study and capture the relevant dates within the CTIS database

• Identify the Institutions and Primary Investigators for each Member State/Country where the clinical trial will be conducted and capture relevant contact information within the CTIS database

• Locate the documents that are deemed applicable at the Member State/country and/or site level for the purposes of Clinical Trial Application (CTA) submissions and upload them into the CTIS database

• Maintain the list of participating Member States/countries, Institutions and Primary Investigator over the life cycle of the study to ensure alignment and synchronization.

• Triage any questions that surface (RFIs, Requests for Information) as a result of capturing and/or reporting on REGN clinical trial applications

• Engage and oversee any vendor engaged to help collect, enter and/or maintain relevant information regarding Clinical Trial Applications (CTA) via the EMA CTIS database

Additionally, may participate as necessary, in obtaining clinical trial insurance for studies/sites. Facilitates the clinical trial insurance process; working as necessary with the insurance vendor and sponsor's insurance group to ensure timely deliverables in preparation for patient enrollment and support throughout the conduct of the clinical study. 

• May contribute to review of Subject Informed Consents to ensure alignment with insurance language.                                                                               

• Requests and maintains Clinical Trial insurance to cover Company sponsored clinical trials according to relevant SOPs and regulations.

• Discontinues / cancels insurance at study completion or country closure

• Maintain metrics on clinical trial insurance requests and expirations and provide to management periodically.

• Ensure all relevant documents are uploaded into the Electronic Trial Master File (eTMF)

• Meets with Insurance Broker/Carriers, Risk Management, and Legal to facilitate study coverage.

• Provides financial impact of insurance provisions to senior leadership, as needed.

• Provides country specific legal and compensation language to law department for the use in Subject Informed Consent Forms.

• Conducts training on clinical trial insurance to study teams and CROs periodically and as needed.

• Filing/uploading of essential clinical documents and maintenance of the TMF as applicable

• Support process documents/insurance SOP’s/training documentation/meeting minutes 

• Manage the exchange of insurance documents with external service providers as applicable

• May maintain file QC schedule for assigned studies and performs periodic quality checks and inventories of study/project TMFs to ensure completeness and inspection ready

• Effectively communicate and drive study document management compliance and quality issues to line manager and offer potential solutions

• May be required to review and access study documents required for site activation and investigational product release, including but not limited to:

• Prepare and maintain transmittals and trackers of essential documents, as applicable

• Provide applicable essential documents to regulatory for submission to the FDA

• Maintain metrics on results of study documentation reviews

Qualifications

Skills:

• Experience in the clinical drug development process, specifically trial planning, and execution practices, including IRB/IEC and Investigator site roles and responsibilities

• Knowledge and understanding of ICH/GCP and regulatory guidelines/directives, especially ICH E6 R2

• Experience in managing Sponsor and Site related contact information and essential documents

• Experience in the creation and management of Investigator and Institution contact information in a CTMS

• Experience in registering essential documents within the Trial Master File structure

• Demonstrates expert knowledge in own field, with a strong understanding of adjacent areas for the development of pragmatic and creative solutions

• Works with management to support the development of department strategy, operational objectives, and matters of significance

• Achieves goals in creative and novel ways, operating with significant autonomy

• Makes decisions on complex to highly complex issues regarding work approach for project components and completion of team tasks and responsibilities

• Team player with a positive attitude and resilience

• Good communication and inter-personal skills

• Strong project management and prioritization skills

• Attention to detail and ability to problem solve and generate results

• Ability to multi-task and work in a fast-paced environment

• Familiarity with CROs and support models for Site Activation

• Familiarity with Veeva Vault Clinical for CTMS and eTMF use

• May require up to 25% travel

• Proficient in oral and written communication, excellent organizational skills and the ability to manage multiple tasks with great attention to detail

• Good  interpersonal skills with an ability to work in a team environment and independently

• Proficient in Microsoft Office software applications

Knowledge and Experience:

3 years in essential or regulatory document management in Pharmaceutical /CRO industry, understanding of clinical study start up requirements and working knowledge of relevant documentation. 

Education:

Bachelor’s degree or equivalent in a life science, nursing qualification or other relevant experience preferred