Collabera
Position Description
The Sr. Clinical Research Specialist (Sr. CRS) will support the execution of clinical research activities related to the ongoing evaluation of product safety and effectiveness following market release. Under supervision, the Sr. CRS may assume project management responsibilities for assigned studies and will be responsible for the timely completion of deliverables consistent with applicable regulatory standards and internal Medtronic requirements. Responsibilities
Prepare and revise study materials and/or training Conduct training of site and/or Medtronic staff Assist in site initiation activities (e.g., study start-up documentation preparation) Set up and maintain accurate progress and study status tracking logs Assist in the preparation of reports, regulatory submissions, publications and presentations Assist in the preparation of budgets and project plans Identify and mitigate quality risk and/or issues associated with assigned studies/activities May arrange conference calls, staff meetings, and training events Assist in the preparation and review of data Oversee follow-up and resolution of site issues Oversee activities performed by extended team members including work direction (e.g., project coordinators, monitors, safety and data specialists, etc.) to ensure compliance with protocol, appropriate regulations and guidelines Able to refer to Standard Operating Procedures (SOPs) and study management processes for guidance on everyday tasks Contribute to process improvement initiatives and participate in training to enhance knowledge Qualifications
Basic Qualifications: Bachelors degree 4+ years’ experience in clinical research (Masters degree will substitute for 1 year experience) Desired/Preferred Qualifications: Working knowledge of Good Clinical Practice (GCP) and regulatory compliance guidelines for conducting clinical studies Proficient knowledge of medical terminology Additional Information
If you are interested and want to apply, please contact:
#J-18808-Ljbffr
The Sr. Clinical Research Specialist (Sr. CRS) will support the execution of clinical research activities related to the ongoing evaluation of product safety and effectiveness following market release. Under supervision, the Sr. CRS may assume project management responsibilities for assigned studies and will be responsible for the timely completion of deliverables consistent with applicable regulatory standards and internal Medtronic requirements. Responsibilities
Prepare and revise study materials and/or training Conduct training of site and/or Medtronic staff Assist in site initiation activities (e.g., study start-up documentation preparation) Set up and maintain accurate progress and study status tracking logs Assist in the preparation of reports, regulatory submissions, publications and presentations Assist in the preparation of budgets and project plans Identify and mitigate quality risk and/or issues associated with assigned studies/activities May arrange conference calls, staff meetings, and training events Assist in the preparation and review of data Oversee follow-up and resolution of site issues Oversee activities performed by extended team members including work direction (e.g., project coordinators, monitors, safety and data specialists, etc.) to ensure compliance with protocol, appropriate regulations and guidelines Able to refer to Standard Operating Procedures (SOPs) and study management processes for guidance on everyday tasks Contribute to process improvement initiatives and participate in training to enhance knowledge Qualifications
Basic Qualifications: Bachelors degree 4+ years’ experience in clinical research (Masters degree will substitute for 1 year experience) Desired/Preferred Qualifications: Working knowledge of Good Clinical Practice (GCP) and regulatory compliance guidelines for conducting clinical studies Proficient knowledge of medical terminology Additional Information
If you are interested and want to apply, please contact:
#J-18808-Ljbffr