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Clinical Research Associate [CRA]
Description✓We are growing and expanding our team of Consultants/CRAs within our Life Sciences practice and have a number of customers and projects with which we are working
✓It is an exciting time to join the Life Sciences Global Domain & Consulting team at Wipro
✓We are looking for motivated CRAs who can work in partnership with our customers in Life Sciences, Pharmaceutical and Device industry to solve their challenges and deliver solutions to impact positive outcome
✓JOB RESPONSIBILITIES
✓The primary focus of the Clinical Research Associate's position is to manage assigned clinical studies in compliance with protocols, company SOPs and applicable regulations and standards including FDA, EU MDD, MDR, ISO 14155:2020
✓The Clinical Research Associate [CRA] is involved in all stages of the clinical study, including assisting with identifying and assessing investigational sites and investigators and setting up, initiating, monitoring and closing down the study
✓Key Responsibilities include the following activities:
✓Contribute to the development of clinical study protocols, case report forms [CRFs] and other study materials
✓Assist in identifying and to assess the suitability of facilities to use as the clinical study site
✓Assist in identifying/selecting an investigator who will be responsible for conducting the study at the local study site
✓Liaise with investigators and site research teams to prepare the necessary documentation for the IRB/EC and to manage any IRB/EC questions
✓Coordinate the execution of study agreements
✓Set up the study sites - ensuring each site has the study materials and conduct site initiation visit and site staff study-specific training
✓Develop and maintain strong and effective relationships with all site personnel through regular communication throughout the study duration with key focus on driving study recruitment and compliance in accordance with the protocol
✓Identify, evaluate, report, and ensure adequate follow-up of adverse events per study protocol, company SOPs and applicable regulations
✓Prepare and conduct on-site study monitoring visits throughout its duration verifying that data entered on to the CRFs is consistent with patient clinical notes
✓Coordinate the collection of completed CRFs from study sites
✓Write high quality and accurate visit reports and follow-up with sites on outstanding items
✓Perform the close-out activities on completion of the study
✓Maintain and file study documentation in an organized manner and archive following study closure • Prepare data for final analysis and contribute to final study summary report as requested
✓Assist in the preparation and/or review of conference abstracts, manuscripts for the assigned studies
✓Monitor the costs of the assigned studies to be in line with the agreed budget and escalate where differences are identified
✓Contribute to development of regulatory documentation for Regulatory Authority applications/ approvals and or renewal
✓Provide data summary and updates of the assigned studies for the internal Product Annual Brand Risk Reviews
✓Participate in the review of departmental SOPs
✓Ensure that process & timeline requirements for Corrective & Preventive Actions [CAPA] are met in accordance with Standard Operating Procedures [SOP's] Qualifications
✓A degree level education in a life science subject or related field
✓2+ years clinical research experience
✓Good computer skills: good knowledge of Microsoft Office including MS Outlook, Word, Excel, and Power Point
✓Basic statistical analysis Skills and Abilities
✓High attention to detail
✓Confident communicator, both verbally and in writing, and in presenting information concisely to others in a group or one to one setting
✓Effective interpersonal skills with ability to work in a team or independently as required
✓Ability to multi-task and manage priorities with effective organizational and time management skills
✓Demonstrated flexibility and adaptability
✓Highly motivated with a proactive approach to learning and problem solving
✓Ability to travel up to 50%, depending on the stage and needs of the clinical study
✓Must be eligible to work in the UK
✓Location: Hybrid working [ Estimated 70% remote / Site visits / London HQ]
✓What is in it for you ?
✓This is a lifetime opportunity to work with and be part of this expanding global life science practice, growing your skills multi-dimensionally
✓If you are interested and meet the criteria required, then we at Wipro would like to see you CV
✓Wipro is ranked as a "Top Employer" as part of the Top Employer Institute annual listings
✓We were assessed on several key HR practices including Diversity and Inclusion
✓LS - Pharma Show more →
✓It is an exciting time to join the Life Sciences Global Domain & Consulting team at Wipro
✓We are looking for motivated CRAs who can work in partnership with our customers in Life Sciences, Pharmaceutical and Device industry to solve their challenges and deliver solutions to impact positive outcome
✓JOB RESPONSIBILITIES
✓The primary focus of the Clinical Research Associate's position is to manage assigned clinical studies in compliance with protocols, company SOPs and applicable regulations and standards including FDA, EU MDD, MDR, ISO 14155:2020
✓The Clinical Research Associate [CRA] is involved in all stages of the clinical study, including assisting with identifying and assessing investigational sites and investigators and setting up, initiating, monitoring and closing down the study
✓Key Responsibilities include the following activities:
✓Contribute to the development of clinical study protocols, case report forms [CRFs] and other study materials
✓Assist in identifying and to assess the suitability of facilities to use as the clinical study site
✓Assist in identifying/selecting an investigator who will be responsible for conducting the study at the local study site
✓Liaise with investigators and site research teams to prepare the necessary documentation for the IRB/EC and to manage any IRB/EC questions
✓Coordinate the execution of study agreements
✓Set up the study sites - ensuring each site has the study materials and conduct site initiation visit and site staff study-specific training
✓Develop and maintain strong and effective relationships with all site personnel through regular communication throughout the study duration with key focus on driving study recruitment and compliance in accordance with the protocol
✓Identify, evaluate, report, and ensure adequate follow-up of adverse events per study protocol, company SOPs and applicable regulations
✓Prepare and conduct on-site study monitoring visits throughout its duration verifying that data entered on to the CRFs is consistent with patient clinical notes
✓Coordinate the collection of completed CRFs from study sites
✓Write high quality and accurate visit reports and follow-up with sites on outstanding items
✓Perform the close-out activities on completion of the study
✓Maintain and file study documentation in an organized manner and archive following study closure • Prepare data for final analysis and contribute to final study summary report as requested
✓Assist in the preparation and/or review of conference abstracts, manuscripts for the assigned studies
✓Monitor the costs of the assigned studies to be in line with the agreed budget and escalate where differences are identified
✓Contribute to development of regulatory documentation for Regulatory Authority applications/ approvals and or renewal
✓Provide data summary and updates of the assigned studies for the internal Product Annual Brand Risk Reviews
✓Participate in the review of departmental SOPs
✓Ensure that process & timeline requirements for Corrective & Preventive Actions [CAPA] are met in accordance with Standard Operating Procedures [SOP's] Qualifications
✓A degree level education in a life science subject or related field
✓2+ years clinical research experience
✓Good computer skills: good knowledge of Microsoft Office including MS Outlook, Word, Excel, and Power Point
✓Basic statistical analysis Skills and Abilities
✓High attention to detail
✓Confident communicator, both verbally and in writing, and in presenting information concisely to others in a group or one to one setting
✓Effective interpersonal skills with ability to work in a team or independently as required
✓Ability to multi-task and manage priorities with effective organizational and time management skills
✓Demonstrated flexibility and adaptability
✓Highly motivated with a proactive approach to learning and problem solving
✓Ability to travel up to 50%, depending on the stage and needs of the clinical study
✓Must be eligible to work in the UK
✓Location: Hybrid working [ Estimated 70% remote / Site visits / London HQ]
✓What is in it for you ?
✓This is a lifetime opportunity to work with and be part of this expanding global life science practice, growing your skills multi-dimensionally
✓If you are interested and meet the criteria required, then we at Wipro would like to see you CV
✓Wipro is ranked as a "Top Employer" as part of the Top Employer Institute annual listings
✓We were assessed on several key HR practices including Diversity and Inclusion
✓LS - Pharma Show more →