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Job Overview
With applicable 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 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 (SSV) 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.

• Perform as needed, initiation, monitoring, and close out visits remotely in accordance with contracted scope of work, using Good Clinical Practices (GCP), applicable regulations, SOPs and work instructions.

• Serves as a 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.

• Collaborate 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.

• Assist 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.

Qualifications

• Bachelor's Degree Bachelor's Degree preferred or as required by local country policies. Degree in scientific discipline or health care preferred. Pref

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• Basic 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 independently on routine tasks and apply critical thinking to tasks with guidance, as needed.

• Ability to establish and maintain effective working relationships with coworkers, managers and clients

• Ability to understand electronic data capture including basic data processing functions.

• Basic knowledge of current International Conference on Harmonization (ICH) and GCP guidelines and applicable regulations to the conduct of clinical research.

• Computer skills including proficient use of Microsoft Word and Excel.

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