RWE - Site Mgr 2

IQVIA; São Paulo; Teletrabalho; BRL 90 000 - 150 000; Tempo integral

Resumo da oferta

IQVIA is seeking a Site Monitoring professional focused on remote monitoring to ensure studies are conducted properly and data are reported per protocol, regulations, and sponsor requirements. On-site monitoring may be required as needed.

Collaborating with COL, PM, RSU and epidemiology, you will handle SSU activities, regulatory submissions, site contracts, budgets, and site documentation while supporting patient recruitment and data query resolution.

Qualificações

• Bachelor's degree in science/healthcare preferred.
• Minimum 2+ years of clinical experience preferred.
• Equivalent combination of education, training and experience may be acceptable.
• Intermediate knowledge of clinical research process and medical terminology.
• Written and verbal communication skills including good command of English.

Responsabilidades

• Performs remote site monitoring to ensure protocol adherence and data reporting.
• May monitor on-site visits when needed.
• Assist with Site ID, site selection and SSU activities.
• Prepare regulatory submissions and track site regulatory documents.
• Maintain site communications and act as liaison with sites and sponsors.
• Review data quality via remote CRF data review and resolve data queries.
• Assist with site payments and visit reports as needed.
• Support Investigator Meetings and site audits if required.

Conhecimentos

English proficiency

Communication

Organization

Problem solving

Time management

Formação académica

Bachelor's Degree in science/healthcare

2+ years clinical experience

Descrição da oferta de emprego

Job Overview

With limited guidance, responsible for remote site monitoring activities to ensure sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. May monitor and/or co-monitor on-site when needed. May perform Site Identification (Site ID) and/or Site Start-Up (SSU) activities.

Essential Functions

• Completes appropriate therapeutic, protocol and clinical research training to perform job duties. Works collaboratively with other functional groups such as Clinical Operations Lead (COL), Project Management, Regulatory Start-Up (RSU) and Epidemiology.
• Performs as needed, Site ID, and site selection activities according to applicable regulations and Standard Operating Procedures (SOPs) including but not limited to: Collection of Site Information Form (SIF) and Confidentiality Disclosure Agreement (CDA) and corresponding tracking and filing and might perform Site Selection Visits (SSVs) as needed.
• Performs as needed SSU activities according to applicable regulations and SOPs, including but not limited to: preparing regulatory/ethics submission packages and obtaining required approvals; collecting and reviewing of regulatory documents for completeness and accuracy; tracking and filing site regulatory documents (Including regulatory /ethics submissions / Approvals, Informed Consent Form (ICF) and others), preparing, reviewing and negotiating of site contracts and budgets with investigator sites; reviewing and agreeing on project planning and project timelines.
• Performs as needed, initiation, monitoring and close out visits remotely and in accordance with contracted scope of work, using Good Clinical Practices (GCP), applicable regulations, SOPs and work instructions. May monitor and/or co-monitor on-site when needed.
• Serves as primary contact between the business and the investigator site and ensures proper documentation of site management communications. Serves as back-up to other Site Managers (SMs).
• In collaboration with the assigned field Clinical Research Associates (CRAs), performs routine site management activities, including, as needed: SSU activities as detailed above, site training, assistance with site questions, patient recruitment and retention management, study supplies management, and other activities needed to ensure that assigned sites are conducting the study(ies) as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.
• Collaborates with field CRAs, as needed, to resolve and document outstanding site issues/action items.
• Reviews the quality and integrity of patient data at assigned sites through the remote review of electronic Case Report Form (CRF) data. Ensures timely transmission of clinical data from assigned study sites and works with sites to resolve data queries.
• Assists with final data review, query resolution and patient casebook signature through database lock. Inclusive of patient profile and data listings review.
• Ensures accurate completion and maintenance of internal systems, databases and tracking tools with site specific information, including (but not limited to) submitting regular visit reports, generating follow-up letters, collection and filing of essential documents and other required study documentation.
• Provides input and updates to the assigned COL regarding site status and deliverables. Escalate issues and/or risks related to site performance to the COL, Clinical Project Manager (CPM) and/or Line Manager (LM) as needed.
• May assist with and attend (as needed) Investigator Meetings on assigned studies.
• Authorized to request onsite visits and/or site audits for reasons of validity.
• May help ensure timely and appropriate site payments and updates to systems as required to ensure proper timing and amount of payments.
• May conduct assessment visits, as needed, to ensure monitoring is being conducted in accordance with the protocol, SOPs, GCP and applicable regulatory requirements.
• May provide assistance to less experienced clinical staff, including demonstrating appropriate interactions with sites, documentation and other monitoring activities.
• May be assigned COL tasks on exceptional basis, as agreed with LM.

Qualifications

• Bachelor's Degree Bachelor's Degree preferred or as required by local country policies. Degree in scientific discipline or health care preferred. Pref
• Minimum of 2 plus years of relevant clinical experience preferred. Pref
• Equivalent combination of education, training and experience may be acceptable. Pref
• Intermediate knowledge of clinical research process and medical terminology.
• Written and verbal communication skills including good command of English language.
• Good organizational and problem-solving skills.
• Ability to manage multiple priorities within various clinical trials.
• Ability to meet deadlines and adhere to project timelines.
• Ability to work indepen