JOB SUMMARY

The Central Monitoring Associate II (CMA II) will perform remote monitoring and site management activities for Phase I-IV clinical research and/or non-interventional studies (NIS) to assess the progress of clinical projects at assigned sites and to ensure these projects are conducted, recorded, and reported in accordance with the protocol, Company and Sponsor standard operating procedures (SOPs), ICH-GCP, and/or all applicable local and federal regulatory requirements. Performs all tasks routinely and independently, seeking guidance as needed.

JOB RESPONSIBILITIES

· Performs remote site qualification, site initiation, site monitoring calls, and close-out visits ensuring regulatory, ICH-GCP and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes. May require knowledge of Good Pharmacoepidemiology Practices (GPP) and Good Epidemiologic Practices (GEP) guidelines for NIS and to adhere to a schedule of data collection from HCPs and patients for NIS, effectively employing technology for tracking.

· Assesses the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.

· Applies query resolution techniques remotely and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines. Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture. Assesses site compliance with electronic data capture requirements.

· May perform Remote Aggregated Data Review (RADaR) utilizing the appropriate tools to identify, respond and manage issues in line with the associated Work Instructions (WI), RADaR guideline and Clinical Monitoring Plan (CMP)/Site Management Plan (SMP) for assigned sites/project. Ability to identify trends within and across sites, escalating issues and trends to develop corrective actions / preventative actions.

· May assesses if investigational product (IP) has been dispensed and administered to subjects/patients according to the protocol, identifying if issues or risks associated with blinded or randomized information related to IP have occurred. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.

· Routinely reviews the site section of the TMF or project master file (PMF) in totality for accuracy, timeliness and completeness. Requests new/updated documents from the site, as required. If remote access is available to an electronic Investigator Site File (eISF), routinely reviews the eISF for accuracy, timeliness and completeness. Reconciles contents of the eISF with the trial master file (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations..

· Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and CMP/SMP Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.

· For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets.

· Acts as primary liaison with project site personnel or NIS reporters, in collaboration with the on-site CRA. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements.

· Prepares for and attends Investigator Meetings, Advisory Committee Meetings and/or sponsor face to face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.

· Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.

· For Real World and Late Phase, the CMA I may be assigned to the Registry Coordinating Center (RCC). Additional responsibilities include:

o Data review, data query resolution and direct data entry of Health Care Provider (HCP) and Patient information.

o Call center-based communications (inbound and outbound) with registry physicians, and/or patients, by utilizing web-based tools and other communication tools to ensure compliance with protocol requirements and relevant guidelines

o Complete chart abstraction activities

o Provide training to junior staff

o Consult with RWLP Regulatory Advisory Services to maintain current information of local and regional requirements for real world and late phase study designs.

QUALIFICATION REQUIREMENTS

· Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience

· Knowledge of Good Clinical Practice/ICH Guidelines and/or other applicable regulatory requirements

· Must demonstrate good computer skills and be able to embrace new technologies. Proficiency in navigation within CTMS systems and Data Platforms for projects required

· Excellent communication, presentation and interpersonal skills. Basic level of critical thinking skills expected

· Ability to manage less than 25% travel

Disclaimer:

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.