Clinical Trials Operations Specialist

General Responsibilities

• Maintain current knowledge of ICH, GCPs, and applicable FDA guidelines, US Federal Regulations pertaining to Clinical Trials and Guidance Documents and Information Sheets. PhRMA code, and industry standards for the monitoring of clinical trials at no cost to Client.
• Invoices should be submitted monthly as directed by Client. The invoices may not be processed until all work products for that period have been received.
• Represent clients PI with the highest ethical and professional standards with all business contacts including, but not limited to the following representatives: investigator and site staff, clinical trial team, Regulatory Affairs, Client Site Monitoring staff, other departments in Clinical Operations and clinical trial vendors, if required.
• Maintain expertise of currently assigned Client SOPs, Client WIs and where applicable; departmental practices, and systems.
• Provide documentation, including but not limited to invoices, time recording, schedule of monitoring visits, and schedule of time off at the direction of Client.

Clinical Trial Operations (CTO) Scope of Work

CTO: An CTO will work remotely as a member of the Clinical Trial Team in the Study Management and Conduct Group supporting the Clinical Trial Leader (CTL), Clinical Trial Manager (CTM), and Feasibility Manager (FM). The CTO is responsible for end-to-end site management activities.

In addition, may be responsible for supporting the CTL and/or CTM in leading the trial teams and is responsible for end-to-end Site Management activities.

CTO Duties and Responsibilities:

• Support Investigator Site File (ISF) development according to SOP and guidance documents. Adapt Trial/OPU documents/templates for study specific trial.
• If US CTL assigned, provide additional support of global/local activities as required
• Under the direction of the CTL/CTM or Feasibility Manager (depending on the task/activity), the CTO will:
• Create trial specific slide decks, training material, etc. in accordance with BI requirements.
• Update and maintain trial-specific system/databases/tracker (e.g. IVRS, BI CTMS, Feasibility Database & Site outreach metrics).
• Perform monitoring trip report review according to current SOPs and guidance documents. Communicate significant issues to the CTL and CTM.
• Closely track site recruitment and patient retention.
• In collaboration with partners ensure quality of TMF for assigned sites.
• Be responsible for site logistics including review, distribution and tracking of site related documents & materials (e.g. protocols, supplies).
• In close partnership with additional stakeholders (e.g. ISP Manager, Site Monitoring) maintain/improve quality, performance and operational oversight for assigned sites, take appropriate actions, escalate, implement mitigation strategies and make recommendations to the CTM and/or FM as appropriate
• Provide operational support to the assigned study Feasibility Manager with tasks to support site identification and country feasibility, i.e., tiering of potential investigator sites, vetting requests assess investigator qualifications, etc.
• Serve as first line of contact for site staff in trial related questions pertaining to planning, conduct and closure of assigned clinical trials and sites.
• Perform quality control of Clinical Trial Report (CTR) Appendices, as requested.
• Develop trial specific documents or communications (e.g. newsletters). Submit for review and approval to CTL and CTM.
• Ensure data quality and integrity through review of systems and trackers (e.g. BRAVE, lab portals, Clinergize).
• Support Customer Relations Group (CRG) in answering and appropriately triaging calls from (potential) sites, as needed and/or requested to appropriate stakeholders.
• Participate in (local/regional) Investigator Meetings, as requested.
• Support site & sponsor inspection readiness activities.
• Adhere to project compliance according to project plans and related tools.
• Coordinate and provide oversight to site start-up and conduct-related activities (e.g. contracts, Essential Documents (e.g. RegDocs), training, Informed Consent Form (ICF) updates, Investigational Medicine Product (IMP) re-supply.
• Actively participate in trial team meetings including the creation and distribution of meeting minutes.
• Review and reconcile invoices/payments with internal partner(s), as appropriate.
• Serve as CAPA lead.

Additional Provisions for CTO Role:

Additional CTO non-trial services may be requested from time-to-time on an as-needed basis related to leveraging service knowledge and insights supporting other activities.

In addition to the CTO responsibilities and duties, they may provide assistance in leading the trial team:

• Support CTL/CTM in the preparation and conduct (may include delivery of presentations and trainings) in (local/regional) Investigator Meetings if required.
• Provide updates on key trial deliverables; take appropriate actions and make recommendations to the CTM (e.g. site initiation, patient recruitment, data cleaning, DBL).
• Perform user acceptance testing.
• Support the CTL/CTM in study sites review and selection.
• Assist with vendor oversight (e.g. lab, ancillary supplies, and pharmacy cards).
• Serve as single point of contact for all CTOs assigned to the trial including the coordination and harmonization of activities, answering trial related questions, etc.
• Update trial budget, systems, project plans and tracker.
• Support accurate local budget and collaborate with CTM to ensure alignment with controlling.
• Enter country level information in BI Clinical Trial Management System (CTMS) and related systems.
• In collaboration with partners, ensure quality of country level TMF.
• Facilitate local trial team meetings.
• Supports the CTL/CTM in ensuring quality oversight and data integrity of the trial at the country level.
• In close partnership with Recruitment and Retention group, CTL and CTM, implement recruitment and retention strategies.
• Provide quality oversight for assigned trial.
• Operationalize the strategic direction given by the CTL/CTM during planning, conduct and closure of assigned trials.
• Work with local colleagues to ensure start-up is achieved according to local timelines/goals.
• Support site & sponsor inspection readiness preparation, represent the trial (Trial/OPU level) during inspections if requested and as appropriate.
• Provide reports to CTL/CTM on OPU contribution status, local issues, budget etc.
• Coordinate close out activities (collection of essential documents, etc.).
• Follow up on audit/inspection findings and actively support implementation of CAPA.
• Partner with the CTL/CTM in the development of a local trial implementation strategy (incl. site engagement/selection/start-up strategy).

Requirements:

Four (4) year degree, preferably in life sciences, or a RN with relevant clinical trial experience.

Desired Experience, Skills and Abilities:

• Maintain current knowledge of ICH, GCPs, applicable FDA guidelines, US Federal Regulations pertaining to Clinical Trials and Guidance Documents and Information Sheets, PhRMA code, and industry standards for the monitoring of clinical trials at no cost to Sponsor.
• Be a highly motivated individual with the ability to think critically, that is detail oriented, can multi-task and understand the clinical trial process, meet deadlines and keep a trial /site on track along with any other qualifications provided by Sponsor.
• Maintain expertise of currently assigned Sponsor SOPs, Working Instructions (WI) and where applicable, departmental practices.
• Proficiency in computer skills, with direct working experience in multiple electronic platforms such as but not limited to: CTMS SharePoint, Clinical Trial portals, Central IRB portals, eSurvey platforms, Time reporting portals, eLearning portals, Access Databases, Microsoft Excel, Microsoft Teams, Adobe Acrobat Professional and scanning software etc.
• Excellent communication skills (written and oral)
• Represent Sponsor with the highest ethical and professional standards with all business contacts including, but not limited to the following representatives: investigator and site staff, clinical trial team, Regulatory Affairs, Site Monitoring staff, other departments within Clinical Operations and if required clinical trial vendors.

Pay starts at $50 to $62 depending on w-2 or 1099 status.