Clinical Research Associate Job Vacancy in ETEAM INFOSERVICES PRIVATE LIMITED Pittsburgh, PA – Latest Jobs in Pittsburgh, PA

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Company Name : ETEAM INFOSERVICES PRIVATE LIMITED
Location : Pittsburgh, PA
Position : Clinical Research Associate

Job Description : This person would need to be able to join team meetings, review plans, and do the monitoring.The Clinical Research Associate is responsible for the initiation, monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices, and Pharmaceutical standards.- Accountable for clinical trial monitoring to ensure effective delivery of clinical trials (e.g. site activation, enrollment, database release), to safeguardthe quality of investigator sites (e.g. patient safety, site health), to maintain investigator and site staff engagement and satisfaction, and to enhance the company’s image with its external stakeholders.- Responsible for the resolution of all protocol-related issues for assigned investigator sites and will work closely with study team members as required in activities associated with the set-up, running and close out of a clinical trial.POSITION RESPONSIBILITIES:Responsible for investigator site management and monitoring for assigned sites:Clinical Trial MonitoringProvide input into and/or develop study related materials such as protocols, Clinical Monitoring Plans, Data Management Plans, eCRF forms, data completions guidelines, patient diaries, recruitment plans, and patient informed consentsEnsure proper conduct of clinical trials in accordance with the Monitoring Plan and applicable prevailing laws, Good Clinical Practices, and Pharmaceutical standards to achieve project goals, timelines and qualityManage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from study start-up through database lock, ensuring relevant timelines and quality deliverables are metIdentify, evaluate and select investigator sites as needed-Interface with the study team as needed, facilitate information flow between members of the study team and assigned investigator sitesPerform investigator site development, coaching and training of site personnel to ensure ongoingcompliance with protocol and the safeguarding of patients; provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks- applicable for general GCP compliance; protocol specific issues to be escalated to study teamConduct site initiation visits in collaboration with study team members as neededProvide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators. Partner with study team to define and support recruitment initiatives at site level- applicableConduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure visits and ensure these are conducted accordance to Monitoring Plan, SOPs and commensurate with emerging issues and technologies.Monitor site level AEs and SAEs and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution-Identify and resolve investigator site issues within required timeframes; agree and develop corrective and preventative actions with investigator and site personnel to close open issues and to preventrecurrence/persistence of issuesResolve data queries within required timelines, prepare investigator site close-out plan and conduct close-out visit within required timelinesMaintain thorough understanding of the product, protocol and therapy area in sufficient details to have appropriate discussions with the investigator and site team- applicableInteract with investigator site heath care professionals in a manner which enhances Pharmaceutical’s credibility, scientific leadership and in order to facilitate client’s clinical development goals- May Support the study team in following up with investigators regarding the ongoing evaluation of subjects- applicable for general guidance; protocol specific issues to be escalatedIn partnership with appropriate study team members contribute to the study level risk plan; mitigate forknown/anticipated risks proactivelyo Monitor site performance using appropriate tools and resources (e.g. metrics, site health, Risk Based Monitoring signals) and take appropriate targeted actiono Apply knowledge of data and analytics to target site level actions for mitigation and control- applicableo Proactively identify, manage and escalate site issueso Identify and address Significant Quality Events or other quality issues at patient and/or site level- applicableo In collaboration with appropriate study team members, create and implement corrective actions and preventative actions (CAPA) as neededo Ensure resolution of investigator site issues in order to maintain sound investigator relations-o Communicate with investigators, study coordinators and other site staff on a regular basis to build and maintain productive relationships and support investigator engagement through medical and scientific discussionQualifications:Bachelors degree in life sciences or professional degree such as Nursing, Pharmacy, Medical background or equivalentExperience in the development of study related documentsExtensive knowledge of clinical trial methodologies , ICH / GCP, FDA and local country regulationsGood Clinical Practices (GCP)Microsoft AccessMonitoring Experience: Minimum 5 years relevant experience in Clinical research monitoringMust be fluent in EnglishJob Types: Part-time, ContractSalary: $80.00 – $85.00 per hourSchedule:Day shiftMonday to FridayOn callAbility to commute/relocate:Pittsburgh, PA: Reliably commute or planning to relocate before starting work (Required)Education:Bachelor’s (Required)Experience:Clinical Research Associates & Coordinators: 1 year (Required)Clinical research monitoring: 5 years (Required)Work Location: One location

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