Assoc Clinical Research Spec - Exempt
Join our team as a Clinical Safety Specialist and play a crucial role in ensuring compliance with clinical study safety and potential complaint data reporting. This position offers the flexibility of working remotely from Virtual, MN, or close proximity to our MDT offices in Minneapolis or Santa Rosa.
Key Responsibilities
ā¢ Review and assess clinical study Adverse Events (AEs) including Serious Adverse Events (SAEs) and device deficiencies.
ā¢ Interact with investigational sites and clinical monitors to gather additional pertinent information as indicated in the Clinical Investigation Plan (CIP).
ā¢ Collaborate with Regulatory Affairs and Product Complaint Reporting teams to ensure timely reporting of AEs, SAEs, and Unanticipated Serious Adverse Device Effects (U[S]ADEs).
ā¢ Author Clinical Safety Management and Potential Complaint Plan (CSMPCP) for assigned studies.
ā¢ Assist with preparation of safety reports for annual reports, clinical study reports, and other documents as required.
ā¢ Support study audits for Safety-specific topics and facilitate Clinical Event Committee (CEC) work.
ā¢ Prepare, attend, and/or lead Safety Trending meetings.
Qualifications
ā¢ Background in science, nursing, or medicine.
ā¢ Experience with RAVE and VAULT databases.
ā¢ Safety experience is a plus.
ā¢ Bachelor's degree required.
ā¢ 0-5 years of experience in a related field.
This position offers the opportunity to work 40 hours a week, with flexibility for remote work. Join us and contribute to the safety and efficacy of our clinical studies.
Apply tot his job
Apply To this Job
Key Responsibilities
ā¢ Review and assess clinical study Adverse Events (AEs) including Serious Adverse Events (SAEs) and device deficiencies.
ā¢ Interact with investigational sites and clinical monitors to gather additional pertinent information as indicated in the Clinical Investigation Plan (CIP).
ā¢ Collaborate with Regulatory Affairs and Product Complaint Reporting teams to ensure timely reporting of AEs, SAEs, and Unanticipated Serious Adverse Device Effects (U[S]ADEs).
ā¢ Author Clinical Safety Management and Potential Complaint Plan (CSMPCP) for assigned studies.
ā¢ Assist with preparation of safety reports for annual reports, clinical study reports, and other documents as required.
ā¢ Support study audits for Safety-specific topics and facilitate Clinical Event Committee (CEC) work.
ā¢ Prepare, attend, and/or lead Safety Trending meetings.
Qualifications
ā¢ Background in science, nursing, or medicine.
ā¢ Experience with RAVE and VAULT databases.
ā¢ Safety experience is a plus.
ā¢ Bachelor's degree required.
ā¢ 0-5 years of experience in a related field.
This position offers the opportunity to work 40 hours a week, with flexibility for remote work. Join us and contribute to the safety and efficacy of our clinical studies.
Apply tot his job
Apply To this Job