Leads the development and management of all activities involved in initiating, monitoring, and completing complex clinical research studies in the clinical study sites. Interacts with internal and external leaders to develop clinical trial portfolios. Evaluates current industry best practices for managing clinical trials. Reviews and provides input into protocol, protocol revisions, WinCAEv definition, (e)CRF design, study Reports and publications.
Serves as first level support for site for data, troubleshooting, Out of Specification investigations, and discussion of unexpected results.
A seasoned professional with wide-ranging experience. Deals with diverse and often times complex issues, where analysis may require in-depth evaluation of many factors. Exercises judgment in evaluating methods and may determine criteria for obtaining solutions. May coordinate the activities of other employees. Networks with senior internal and external personnel in area of expertise as well as some key contacts outside area of expertise.
Responsible for maintaining and continuously improving the quality system and achieving quality objectives through daily actions.
Roles & Responsibilities:
- Performing site assessments and provide input to the site selection process
- Driving site contracting, together with study managers
- Ensuring that IRB/EC/Health Authority approvals are obtained and meet the associated regulatory requirements
- Authoring the Study Monitoring Plan and execution of the plan in compliance with visit frequency and all assigned tasks
- Planning and execution of the Study Logistics Plan, including delegation of activities to the Support Group, as appropriate.
- Performing site initiation, interim monitoring, and site close out visits
- Serving as key contact for study site personnel
- Safeguarding safety (study subject and site personnel) and compliance to the Study Protocol, SOP(s), GxP, and all governing regulations via monitoring vigilance and communication, both on site and remotely, throughout the study
- Performs Source Data Verification (SDV), generates queries, and oversees query resolution
- Reconciles study files and prepares them for archiving
- Bachelor’s degree in chemistry, biology, or medical science, or other relevant field
- 3 years of experience as a Clinical Research Associate (CRA) or equivalent combination of skills, work experience and education
- Knowledge of applicable standards and regulations for clinical trials and lab conduct [International Conference of Harmonization Good Clinical Practice standards (ICH-GCP), FDA Regulations, and IVD Directives]
- Practical experience in study monitoring according to global standards (ICH)
- Ability to make sound decisions and to analyze and solve problems; makes independent choices and takes responsibility for one’s own actions
- Demonstrated experience in computer skills including Microsoft Office, Google, and basic templates
- Knowledge and mastery of basic Statistics
- Ability to recognize and resolve obstacles/issues and deliver high quality work within timelines
- Strong organizational, management, planning, decision making, problem solving, and interpersonal skills
- Ability to work in local and global study teams, including virtual teams; cultural awareness
- Has training/experience on various study types and/or special knowledge in infectious diseases
- Possesses coaching skills
- Lab experience, sample handling and workflow
- Experience on cobas instruments, handling of technical data
- Strong communication skills
- Indianapolis based (on campus)
Roche ist ein Arbeitgeber, bei dem Chancengleichheit zählt.Research & Development, Research & Development > Clinical Development