Job details
Job type full-time
Full job description
Overview: health decisions is a specialty cro that utilizes a broad expertise across women’s health research with adaptive design and adaptive operational capabilities to deliver medicines and diagnostics of value to women worldwideWe are seeking an experienced clinical research associate to join our teamThe cra will be responsible for managing and supporting site activities to ensure the overall integrity of study implementation and adherence to study protocol at assigned clinical sitesServes as the primary contact for sites to convey project information and for study-related questions and issuesResponsibilities:
Responsible for managing and supporting site activities to ensure the overall integrity of study implementation and adherence to study protocol at assigned clinical sites.
Serves as the primary contact for sites to convey project information and for study-related questions and issues.
Responsible for building strong, collaborative relationships with investigators and staff at assigned clinical sites.
Frequently communicates with site staff to provide study updates, discuss site-specific recruitment, follow-up on outstanding items, and ensure sites is receiving support necessary to met study expectations
Responsible for independently performing central data review to ensure data quality and adherence to the study protocol.
Responsible for maintaining a level of data review consistent with the study project management plan, clinical monitoring plan, and other governing documents, as applicable.
Responsible for reviewing site performance metrics and working wiith assigned sites to ensure recruitment goals are met, data entry and query resolution is timely and of high quality, study files are inspection-ready, and monitoring issues are closed in a timely manner.
Partners with clinical trial associates (ctas) to ensure seamless management of assigned clinical sites.
Frequently communicates with cras to share updates on assigned sites, discuss site issues and concerns, and agree actions for resolving issues and deficiencies at the site.
Works with the ctas to prepare for and follow-up of on-site monitoring visits by participating in pre-visit calls with ctas and taking responsibility for the resolution of issues identified during onsite visits that must be handled onsite.
Manages or assists with study feasibility activities including but not limited to assisting with development of feasibility survey, potential site list, collection of feasibility data, and reporting of results.
Performs tasks in internal and client-specific systems, as required
Collects and reviews all essential documents from investigative sites.
Responsible for the submission and correction of regulatory document packages for site activation or ip shipment approval.
Provides support for investigative site staff with regulatory submissions, protocol questions, and vendor support as needed.
Assists with the creation and/or evaluation of informed consent and hipaa forms.
Responsible for managing the central irb for the study duration.
Reviews study material requiring sponsor and irb approval prior to submission.
Supports sites through local irb submissions for the study duration.
Responsible for coordination and shipment of all site supplies.
Responsible for the submission and correction of regulatory document packages for site activation or ip shipment approval.
Coordinates and manages all site payments for assigned sites.
Demonstrates understanding of assigned protocol(s) and trial specific manuals/plans to ensure quality and adherence across assigned sites.
Demonstrates understanding of study management tasks and responsibilities necessary to implement compliance with protocol/regulatory requirements and hd sops.
May be asked to complete rejuvenation visits or other participate in co-monitoring activities to develop professionally
Other in-house duties as assigned
Qualifications: the successful candidate will hold a bs/ba degree (or its international equivalent) preferably in a scientific or health-related field, nursing qualification or relevant experiencePrior experience in the conduct of clinical research including ich-gcp requirements, drug/device development process, regulatory compliance, study start-up or study coordinationExperience in healthcare settings helpfulWorking knowledge of medical terminology, fda regulations and ich guidelinesExcellent interpersonal and organizational skills with strong attention to detailDemonstrated ability to meet timelines and multi-task to complete multiple deliverables in parallelStrong computer skills, including a solid understanding of microsoft office suiteDemonstrated ability to learn other applicationsExcellent written, oral communication, and organization skillsAbility to work with minimal supervision
Health decisions provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
