Lead Clinical Research Associate II - OQSIE
Andover, MA 01810
About the Job
Description:
Responsibilities Job Purpose:
The Lead Clinical Research Associate (CRA) reports to and works closely with the Director of Monitoring, Quality and Training
to provide leadership and mentoring to a team of CRAs. The Lead CRA will oversee study start-up activities, implementation, monitoring, and close-out activities of multiple clinical trials and process-improvement activities. The Lead CRA works with CROs, and CRA teams to assure that protocol requirements, regulatory guidelines and study timelines are defined and met.
The Lead CRA will also ensure that Director of Monitoring, Quality and Training is aware of all monitoring metrics and critical issues. The Lead CRA is the key representative for monitoring responsibilities and assists assigned study monitors in maintaining relationships and rapport with clinical investigational site personnel. This position will review monitoring trends, track monitoring deliverables, review trip reports, and recommend potential solutions to identified issues.
Main Tasks:
• Review and update with the clinical study managers and CRAs a monitoring plan for all assigned projects
• Conducts monitoring report review. Tracks visit and trip report metrics and summarize/report to teams.
• Reviews site data quality trends via trip reports and data review including queries and protocol deviations. Monitors site performance and compliance and provide management with necessary reports, updates and assists sites and data management with data query resolution
• Participates in CRA project-specific training.
• Update or develop materials related to the training and presentations for CRA training, Site Initiation Visits and Investigator Meetings.
• Provides a key role in problem solving and issue escalation, regarding logistics and monitoring issues, with proposed solutions to the Director of Monitoring, Quality and Training.
• Train, assists and mentor CRAs with monitoring activities, to ensure compliance with study protocols, regulatory requirements, and Smith & Nephew SOPs and procedures. Conducts all types of clinical monitoring visits, e.g. pre-study qualifications, initiations, on site and remote monitoring, and close-out) which includes all preparatory and follow-up aspects as needed.
• Mentors and co-monitors with CRAs on assigned teams.
• Prepares clinical sites for regulatory agency inspections and sponsor audits.
Experience & Knowledge Essential I. Job Requirements:
• Bachelor's degree ln life sciences or related field or equivalent education and experience.
• Minimum 5 years' experience in monitoring and site management at either a CRO or Sponsor company, minimum on 2 years in a leading position.
• Preferred previous experience in medical device industry.
II. Knowledge, Skills, and Abilities
• Highly organized and detail-oriented
• Computer and EDC literate.
• Strong problem solving abilities.
• Excellent written and verbal communication and time management skills.
• Excellent understanding of the clinical research process, clinical trial-related systems and procedures, regulations and GCPs.
• Must have excellent people skills and demonstrate the ability to work successfully in a team environment.
• Ability to prioritize and to manage multiple tasks as necessary.
III. Quality and Health & Safety:
• Knows and adheres to the quality policy of the company and the quality-related procedures and instructions.
• Reports any deviation in product or process, of which he/she becomes aware, to his/her manager or the Quality department.
• Completes all necessary training in the area of Quality and GMP (Good Manufacturing Practice).
• Immediately reports any dissatisfaction or complaint which is brought to their attention from a customer or patient regarding a Smith & Nephew product (e.g. in terms of quality, durability, reliability, safety or performance} to the complaints department.
• Complies with all ethics, health, safety and environmental policies, procedures and job hazard analyses applicable to specified job activities; including medical evaluations as required by job function.
Skills:
Job Requirements:
Bachelor's degree ln life sciences or related field or equivalent education and experience.
Minimum 5 years' experience in monitoring and site management at either a CRO or Sponsor company, minimum on 2 years in a leading position.
Preferred previous experience in medical device industry
Responsibilities Job Purpose:
The Lead Clinical Research Associate (CRA) reports to and works closely with the Director of Monitoring, Quality and Training
to provide leadership and mentoring to a team of CRAs. The Lead CRA will oversee study start-up activities, implementation, monitoring, and close-out activities of multiple clinical trials and process-improvement activities. The Lead CRA works with CROs, and CRA teams to assure that protocol requirements, regulatory guidelines and study timelines are defined and met.
The Lead CRA will also ensure that Director of Monitoring, Quality and Training is aware of all monitoring metrics and critical issues. The Lead CRA is the key representative for monitoring responsibilities and assists assigned study monitors in maintaining relationships and rapport with clinical investigational site personnel. This position will review monitoring trends, track monitoring deliverables, review trip reports, and recommend potential solutions to identified issues.
Main Tasks:
• Review and update with the clinical study managers and CRAs a monitoring plan for all assigned projects
• Conducts monitoring report review. Tracks visit and trip report metrics and summarize/report to teams.
• Reviews site data quality trends via trip reports and data review including queries and protocol deviations. Monitors site performance and compliance and provide management with necessary reports, updates and assists sites and data management with data query resolution
• Participates in CRA project-specific training.
• Update or develop materials related to the training and presentations for CRA training, Site Initiation Visits and Investigator Meetings.
• Provides a key role in problem solving and issue escalation, regarding logistics and monitoring issues, with proposed solutions to the Director of Monitoring, Quality and Training.
• Train, assists and mentor CRAs with monitoring activities, to ensure compliance with study protocols, regulatory requirements, and Smith & Nephew SOPs and procedures. Conducts all types of clinical monitoring visits, e.g. pre-study qualifications, initiations, on site and remote monitoring, and close-out) which includes all preparatory and follow-up aspects as needed.
• Mentors and co-monitors with CRAs on assigned teams.
• Prepares clinical sites for regulatory agency inspections and sponsor audits.
Experience & Knowledge Essential I. Job Requirements:
• Bachelor's degree ln life sciences or related field or equivalent education and experience.
• Minimum 5 years' experience in monitoring and site management at either a CRO or Sponsor company, minimum on 2 years in a leading position.
• Preferred previous experience in medical device industry.
II. Knowledge, Skills, and Abilities
• Highly organized and detail-oriented
• Computer and EDC literate.
• Strong problem solving abilities.
• Excellent written and verbal communication and time management skills.
• Excellent understanding of the clinical research process, clinical trial-related systems and procedures, regulations and GCPs.
• Must have excellent people skills and demonstrate the ability to work successfully in a team environment.
• Ability to prioritize and to manage multiple tasks as necessary.
III. Quality and Health & Safety:
• Knows and adheres to the quality policy of the company and the quality-related procedures and instructions.
• Reports any deviation in product or process, of which he/she becomes aware, to his/her manager or the Quality department.
• Completes all necessary training in the area of Quality and GMP (Good Manufacturing Practice).
• Immediately reports any dissatisfaction or complaint which is brought to their attention from a customer or patient regarding a Smith & Nephew product (e.g. in terms of quality, durability, reliability, safety or performance} to the complaints department.
• Complies with all ethics, health, safety and environmental policies, procedures and job hazard analyses applicable to specified job activities; including medical evaluations as required by job function.
Skills:
Job Requirements:
Bachelor's degree ln life sciences or related field or equivalent education and experience.
Minimum 5 years' experience in monitoring and site management at either a CRO or Sponsor company, minimum on 2 years in a leading position.
Preferred previous experience in medical device industry
Source : OQSIE
