Clinical Research Associate

Benefits

Qualifications

• •A minimum of 3+ years of clinical research experience in conducting clinical trials
• •Prior phase II or III experience required
• •A solid understanding of the recruitment methods, drug development process, ICH guidelines/GCP and specifically, each step within the clinical trial process
• •Sophisticated understanding and highly skilful utilization of Microsoft Apps such as Outlook, Word, Excel, and Teams
• •Ability to travel internationally to visit clinical sites and for study meetings
• •Amount will vary upon project needs (up to 20%)
• •Enjoys building relationships with KOLs and site personnel
• •Willing to travel to establish relationships
• •Ability to successfully engage and work collaboratively with global team members/colleagues
• •Ability to support building and delivery of patient enrolment strategies
• •Excellent interpersonal and decision-making skills
• •Demonstrates innovation, possesses drive, energy and enthusiasm to deliver the program objectives
• •Ability to review and assess clinical data
• •Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs
• •Excellent written and oral communication skills
• •12 more items(s)

Responsibilities

• •The Clinical Research Associate (CRA) is responsible for Supporting all aspects of Clinical Trial Management for complex, global studies from study planning and start up through study close out
• •This role will collaborate with functional team members, CROs, and vendors to successfully deliver clinical studies under direction from Clinical Trial Manager or Director
• •The CRA is responsible for adherence to all performance metrics and quality of deliverables in the clinical trial
• •Directs and completes communication between the project team and site personnel to ensure that they are appropriately trained, remain current with project requirements, and have a thorough understanding of study milestones and deliverables
• •Review/approve/track vendor invoices and manage accruals and payment process for all assigned clinical trial vendors including investigational sites
• •Initiates and builds solid professional relationships with clinical site staff
• •Partners with the CRO to ensure robust ongoing data monitoring strategies carried out effectively to ensure delivery of high-quality data
• •Creation and development of study trackers
• •Develop and provide clear, complete documentation of study-specific meetings, action items and action item closure for assigned study meetings
• •Responsible for the development and management of clinical trial documents including (but not limited to), consent documents, site welcome packets, study binders, etc
• •Responsible for reviewing assigned study related plans, processes, agreements, and guidelines
• •Following and implementing assigned study related plans, processes, agreements, and guidelines
• •Responsible for requesting and logging CRO and vendor RFIs / RFPs contracts/work orders and specifications to enable study objectives to be met
• •Reviews and approves essential document packages to enable timely site activations
• •Conducts and tracks Monitoring Report Review to ensure compliance with procedures across duration of study and documentation is complete
• •Provides close oversight on the findings on the monitoring reports and loops back with broader team to provide updates as needed
• •Assess and support investigator performance guidance and adherence to protocol, and proactively addresses conduct issues and enrollment problems, as necessary
• •Responsible for oversight on the maintenance of the TMF and completeness at the end of the study
• •Perform periodic QC of the TMF
• •Oversee the execution of clinical trial activities in accordance with Good Clinical Practices
• •Ensures compliance of clinical trials with national regulatory requirements and co-monitoring the assigned clinical trial following company SOPs
• •Ensures the study is "inspection ready" contemporaneously
• •Responsible for supporting functional activities of Clinical Trial Associates allocated to the project through leadership and training as indicated and appropriate
• •All other duties as assigned
• •Tenacity to work in a fast-paced team environment
• •Possesses excellent planning, time management & coordination skills
• •23 more items(s)