Clinical Research Associate II
The Sr. Clinical Research Associate is responsible for planning, executing and managing clinical studies.
Responsibilities include, but not limited to, the following:
- Manages contract research organizations (CROs) to oversee projects and interactions with study site investigators.
- Builds strong relationships with investigators and site personnel. Serves as liaison between sites and Sekisui Diagnostics.
- Assures compliance of clinical studies with the protocol, Good Clinical Practice (GCP), all applicable regulatory requirements and standard operating procedures (SOPs).
- Assists in the development of study documents and study-specific plans.
- Conducts or oversees site selection, initiation, interim monitoring, and study closeout activities.
- Ensures the clinical study is being conducted in accordance with the approved project plan.
- Ensures adequate monitoring is conducted at clinical sites and appropriate resources are maintained during clinical studies.
- Reviews study correspondence and monitoring visit reports.
- Responsible for study enrollment tracking and monitors the collection of clinical data for quality and trending.
- Monitors the progress of clinical activities and provides project updates and issues to internal Sekisui stakeholders.
- Develops and manages study timelines; responsible for executing studies within agreed timelines.
- Evaluates clinical data, ensures data is accurate and complete, and creates reports for presentations and submissions.
- Responsible for the preparation and maintenance of the Trial Master File and for the management of files at a CRO.
- Ensures the study files and sites are ready for inspection.
- Participates in creating or improving departmental procedures.
Education / Experience:
- Bachelor’s degree in a science or health care field.
- A minimum of 5 years of clinical research experience in the medical device or in vitro diagnostic industry.
- Strong knowledge of Microsoft Office and project management software, including Microsoft Project.
- Thorough knowledge of clinical trial databases.
- Demonstrated ability to collaborate and work effectively within a cross-functional team.
- Ability to manage and communicate effectively with CROs and vendors.
- Strong attention to detail and accuracy.
- Excellent written and oral communication skills.
- Ability to take initiative, identify risks, and proactively resolve or elevate problems in a timely manner.
- Ability to multi-task and must be able to work in a fast paced environment.
- Thorough knowledge of FDA regulations and ICH-GCP.
- Available to travel approximately 30-40%.
Thank you for your interest in this position. Only those Applicants selected for an interview will be contacted