hackajob is collaborating with Oracle to connect them with exceptional professionals for this role.
Description
With ongoing and ground-breaking developments in Oncology and Rare Disease, an increased focus on more scientific, targeted medicine and continuous integration of technology into development and delivery of medicine, there has never been a more exciting time to join us!
As a global leader we're looking for a Senior Lead Clinical Research Associate (CRA) to drive success as part of our Non-interventional Study team.
Join Oracle as a Lead CRA and make a real impact by guiding teams, ensuring top-quality clinical research, and driving groundbreaking projects on a global scale!
What you will do
As a Senior Lead Clinical Research Associate at Oracle, you will:
* Drive study start-up: Develop feasibility questionnaires, identify and assess potential study sites, and ensure proper site selection in close collaboration with Project Managers and Sponsors.
* Oversee contracts and budgets: Review and track site contracts and budgets for study specifications, working closely with CRA and contracting teams, and involve contract specialists for legal matters.
* Ensure regulatory compliance: Coordinate with regulatory teams and CRAs to ensure all ethical committee (EC) requirements are met and support the preparation and submission of essential site documents.
* Lead study site management: Supervise site activation and ongoing management, including monitoring activities from feasibility to close-out, in line with GCP, SOPs, study protocols, and plans.
* Conduct Feasibility Assessments: Organize, identify and manage the feasibility process with CRA's.
* Train and coordinate CRAs: Oversee, mentor, and train a cross-country team of Clinical Research Associates, develop project-specific training materials, and ensure delivery of high-quality site management.
* Monitor progress and quality: Create and maintain study trackers, monitor CRA activities and site deliverables, identify and escalate critical issues, and review/approve monitoring reports.
* Foster team collaboration: Act as the key point of contact between the study team, Sponsor, study sites, and CRAs, supporting strong working relationships and continuous process improvement.
* Travel for site initiations, closures or quality visits: Be available to travel to clinical sites to train and monitor site activities as needed. While there is no guaranteed travel, flexibility is required.
Required Experience
* Education : Bachelor's degree in Life Sciences, Medical Science, Pharmacy, Public Health, or equivalent, with a minimum of three years' hands-on clinical research experience.
* Clinical research expertise : At least 3 years of experience as a CRA, including site initiation, Trial Master File (TMF) management, and site monitoring for both clinical and non-interventional studies.
* Communication skills : Outstanding spoken and written proficiency in English (C1 level minimum). Additional languages are considered a strong asset.
* Technical proficiency : Comfort with MS Office, EDC, CTMS experience and willingness to learn and handle various technical systems and tools.
* Personal qualities : Exceptional organizational and problem-solving skills, strong cross-cultural
team work, initiative in process optimization, and the ability to manage competing priorities in a fast-paced environment.
* Financial management: Experience reviewing site contracts, budget and invoices.
* Attention to detail : Ability to work independently with careful, precise, and thorough execution of complex tasks.
Responsibilities
What you will do
As a Senior Lead Clinical Research Associate at Oracle, you will:
* Drive study start-up: Develop feasibility questionnaires, identify and assess potential study sites, and ensure proper site selection in close collaboration with Project Managers and Sponsors.
* Oversee contracts and budgets: Review and track site contracts and budgets for study specifications, working closely with CRA and contracting teams, and involve contract specialists for legal matters.
* Ensure regulatory compliance: Coordinate with regulatory teams and CRAs to ensure all ethical committee (EC) requirements are met and support the preparation and submission of essential site documents.
* Lead study site management: Supervise site activation and ongoing management, including monitoring activities from feasibility to close-out, in line with GCP, SOPs, study protocols, and plans.
* Conduct Feasibility Assessments: Organize, identify and manage the feasibility process with CRA's.
* Train and coordinate CRAs: Oversee, mentor, and train a cross-country team of Clinical Research Associates, develop project-specific training materials, and ensure delivery of high-quality site management.
* Monitor progress and quality: Create and maintain study trackers, monitor CRA activities and site deliverables, identify and escalate critical issues, and review/approve monitoring reports.
* Foster team collaboration: Act as the key point of contact between the study team, Sponsor, study sites, and CRAs, supporting strong working relationships and continuous process improvement.
* Travel for site initiations, closures or quality visits: Be available to travel to clinical sites to train and monitor site activities as needed. While there is no guaranteed travel, flexibility is required.
Qualifications
Disclaimer:
Certain U.S. based or U.S. customer or client-facing roles may be required to comply with applicable requirements, such as immunization/occupational health mandates, and/or drug testing requirements.
Range and benefit information provided in this posting are specific to the stated locations only
US: Hiring Range in USD from: $74,100 to $148,300 per annum. May be eligible for bonus and equity.
Oracle maintains broad salary ranges for its roles in order to
Description
With ongoing and ground-breaking developments in Oncology and Rare Disease, an increased focus on more scientific, targeted medicine and continuous integration of technology into development and delivery of medicine, there has never been a more exciting time to join us!
As a global leader we're looking for a Senior Lead Clinical Research Associate (CRA) to drive success as part of our Non-interventional Study team.
Join Oracle as a Lead CRA and make a real impact by guiding teams, ensuring top-quality clinical research, and driving groundbreaking projects on a global scale!
What you will do
As a Senior Lead Clinical Research Associate at Oracle, you will:
* Drive study start-up: Develop feasibility questionnaires, identify and assess potential study sites, and ensure proper site selection in close collaboration with Project Managers and Sponsors.
* Oversee contracts and budgets: Review and track site contracts and budgets for study specifications, working closely with CRA and contracting teams, and involve contract specialists for legal matters.
* Ensure regulatory compliance: Coordinate with regulatory teams and CRAs to ensure all ethical committee (EC) requirements are met and support the preparation and submission of essential site documents.
* Lead study site management: Supervise site activation and ongoing management, including monitoring activities from feasibility to close-out, in line with GCP, SOPs, study protocols, and plans.
* Conduct Feasibility Assessments: Organize, identify and manage the feasibility process with CRA's.
* Train and coordinate CRAs: Oversee, mentor, and train a cross-country team of Clinical Research Associates, develop project-specific training materials, and ensure delivery of high-quality site management.
* Monitor progress and quality: Create and maintain study trackers, monitor CRA activities and site deliverables, identify and escalate critical issues, and review/approve monitoring reports.
* Foster team collaboration: Act as the key point of contact between the study team, Sponsor, study sites, and CRAs, supporting strong working relationships and continuous process improvement.
* Travel for site initiations, closures or quality visits: Be available to travel to clinical sites to train and monitor site activities as needed. While there is no guaranteed travel, flexibility is required.
Required Experience
* Education : Bachelor's degree in Life Sciences, Medical Science, Pharmacy, Public Health, or equivalent, with a minimum of three years' hands-on clinical research experience.
* Clinical research expertise : At least 3 years of experience as a CRA, including site initiation, Trial Master File (TMF) management, and site monitoring for both clinical and non-interventional studies.
* Communication skills : Outstanding spoken and written proficiency in English (C1 level minimum). Additional languages are considered a strong asset.
* Technical proficiency : Comfort with MS Office, EDC, CTMS experience and willingness to learn and handle various technical systems and tools.
* Personal qualities : Exceptional organizational and problem-solving skills, strong cross-cultural
team work, initiative in process optimization, and the ability to manage competing priorities in a fast-paced environment.
* Financial management: Experience reviewing site contracts, budget and invoices.
* Attention to detail : Ability to work independently with careful, precise, and thorough execution of complex tasks.
Responsibilities
What you will do
As a Senior Lead Clinical Research Associate at Oracle, you will:
* Drive study start-up: Develop feasibility questionnaires, identify and assess potential study sites, and ensure proper site selection in close collaboration with Project Managers and Sponsors.
* Oversee contracts and budgets: Review and track site contracts and budgets for study specifications, working closely with CRA and contracting teams, and involve contract specialists for legal matters.
* Ensure regulatory compliance: Coordinate with regulatory teams and CRAs to ensure all ethical committee (EC) requirements are met and support the preparation and submission of essential site documents.
* Lead study site management: Supervise site activation and ongoing management, including monitoring activities from feasibility to close-out, in line with GCP, SOPs, study protocols, and plans.
* Conduct Feasibility Assessments: Organize, identify and manage the feasibility process with CRA's.
* Train and coordinate CRAs: Oversee, mentor, and train a cross-country team of Clinical Research Associates, develop project-specific training materials, and ensure delivery of high-quality site management.
* Monitor progress and quality: Create and maintain study trackers, monitor CRA activities and site deliverables, identify and escalate critical issues, and review/approve monitoring reports.
* Foster team collaboration: Act as the key point of contact between the study team, Sponsor, study sites, and CRAs, supporting strong working relationships and continuous process improvement.
* Travel for site initiations, closures or quality visits: Be available to travel to clinical sites to train and monitor site activities as needed. While there is no guaranteed travel, flexibility is required.
Qualifications
Disclaimer:
Certain U.S. based or U.S. customer or client-facing roles may be required to comply with applicable requirements, such as immunization/occupational health mandates, and/or drug testing requirements.
Range and benefit information provided in this posting are specific to the stated locations only
US: Hiring Range in USD from: $74,100 to $148,300 per annum. May be eligible for bonus and equity.
Oracle maintains broad salary ranges for its roles in order to
Lead CRA- International Observational Studies in remote at Unknown Company
This position is listed as contract and onsite.