Clinical Research Associate Manager (REMOTE)
About the position
The CRA Manager will provide leadership, oversight and operational direction to a team of in-house and regional Clinical Research Associates (CRAs). This individual has knowledge and experience managing study activities from site selection, start-up, to close-out with adherence to regulations, maintaining data integrity, and aligning deliverables with corporate goals. As a key contributor to the Global Clinical Operations team, this position develops and assesses SOPs, assesses processes for efficiency and compliance. This position requires the ability to be detail-oriented, organized, and productive with a keen interest in medical device and biologics research.
Responsibilities
• Manage a team of in-house and regional CRAs, providing guidance on study conduct, clinical operational and monitoring strategy, as well as professional growth.
• Serve as primary point of contact for CRA escalations and issue resolution across assigned studies.
• Partner with Clinical Project Managers and cross functional teams to support all phases of a clinical study including protocol, CRF, and monitoring plan development, essential document management, contract execution, IRB/EC support, recruitment, site payment reconciliation and development of site tools.
• Conducts Qualification, Site Initiation, Interim, and Close-Out monitoring visits to ensure adherence to monitoring plan, protocol, and regulations.
• Train site personnel regarding the protocol and applicable regulatory requirements.
• Ensure each site is meeting its goals of follow-up rate, data clean deadlines, protocol compliance, and enrollment.
• Lead study meetings to ensure completion of established project team goals and objectives, including study training and data review.
• Facilitate corrective action assessment and maintain TMF in BIMO readiness.
• Provide study status updates to Management team and develop sufficient resolution of identified action items.
• Contribute to annual reports, data management, data analysis, and publication support.
• Develop and assesses SOPs annually, as needed.
• Maintain current knowledge of applicable US and international clinical regulations and guidance documents.
• Participate in department systems and development initiatives including related trainings.
• Support investigator meetings as needed.
• Support Protocol Deviation and Adverse Event review and reporting.
• Maintain credentialing requirements at hospitals and clinics as needed.
• Complete projects and tasks consistent with corporate objectives.
• Support the Clinical Operations team in general and with various improvement projects.
• Perform other duties as assigned.
Requirements
• Bachelor of Science degree preferably in natural sciences or related field, or related practical experience.
• Minimum 8 years of clinical research experience, medical device experience preferred. This should includes a minimum of 3 years in a CRA management, or lead CRA capacity.
• Proficient in Microsoft Word and Excel, and the ability to quickly learn other software tools and applications, such as Access, etc.
• US IDE, IND, and OUS experience preferred.
• Ability to foresee and prevent risks and understand when to elevate issues to management and recommend corrective action.
• Excellent time management skills.
• Ability to recognize potential obstacles and develop solutions to resolve them with minimal consequence within set timelines or change direction if priorities are modified.
• Ability to make critical, independent decisions and be accountable for actions within a fast-moving environment.
• Ability to perform at high-level with limited supervision and effectively partner with team members when necessary.
• Ability to exercise critical thinking skills in selecting methods, techniques, and evaluation criteria.
• Ability to develop strong relationships with investigative sites.
• Excellent verbal and written communication skills and a demonstrated ability to communicate clearly and professionally.
• Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
• Ability to read, understand and abide by company procedures. Ability to define problems, collect data, establish facts, draw valid conclusions and report on findings.
Benefits
• medical
• prescription drug
• dental and vision insurance
• flexible spending accounts
• participation in 401(k) savings plan
• various paid time off benefits, such as PTO, short- and long-term disability and parental leave
Apply To this Job
The CRA Manager will provide leadership, oversight and operational direction to a team of in-house and regional Clinical Research Associates (CRAs). This individual has knowledge and experience managing study activities from site selection, start-up, to close-out with adherence to regulations, maintaining data integrity, and aligning deliverables with corporate goals. As a key contributor to the Global Clinical Operations team, this position develops and assesses SOPs, assesses processes for efficiency and compliance. This position requires the ability to be detail-oriented, organized, and productive with a keen interest in medical device and biologics research.
Responsibilities
• Manage a team of in-house and regional CRAs, providing guidance on study conduct, clinical operational and monitoring strategy, as well as professional growth.
• Serve as primary point of contact for CRA escalations and issue resolution across assigned studies.
• Partner with Clinical Project Managers and cross functional teams to support all phases of a clinical study including protocol, CRF, and monitoring plan development, essential document management, contract execution, IRB/EC support, recruitment, site payment reconciliation and development of site tools.
• Conducts Qualification, Site Initiation, Interim, and Close-Out monitoring visits to ensure adherence to monitoring plan, protocol, and regulations.
• Train site personnel regarding the protocol and applicable regulatory requirements.
• Ensure each site is meeting its goals of follow-up rate, data clean deadlines, protocol compliance, and enrollment.
• Lead study meetings to ensure completion of established project team goals and objectives, including study training and data review.
• Facilitate corrective action assessment and maintain TMF in BIMO readiness.
• Provide study status updates to Management team and develop sufficient resolution of identified action items.
• Contribute to annual reports, data management, data analysis, and publication support.
• Develop and assesses SOPs annually, as needed.
• Maintain current knowledge of applicable US and international clinical regulations and guidance documents.
• Participate in department systems and development initiatives including related trainings.
• Support investigator meetings as needed.
• Support Protocol Deviation and Adverse Event review and reporting.
• Maintain credentialing requirements at hospitals and clinics as needed.
• Complete projects and tasks consistent with corporate objectives.
• Support the Clinical Operations team in general and with various improvement projects.
• Perform other duties as assigned.
Requirements
• Bachelor of Science degree preferably in natural sciences or related field, or related practical experience.
• Minimum 8 years of clinical research experience, medical device experience preferred. This should includes a minimum of 3 years in a CRA management, or lead CRA capacity.
• Proficient in Microsoft Word and Excel, and the ability to quickly learn other software tools and applications, such as Access, etc.
• US IDE, IND, and OUS experience preferred.
• Ability to foresee and prevent risks and understand when to elevate issues to management and recommend corrective action.
• Excellent time management skills.
• Ability to recognize potential obstacles and develop solutions to resolve them with minimal consequence within set timelines or change direction if priorities are modified.
• Ability to make critical, independent decisions and be accountable for actions within a fast-moving environment.
• Ability to perform at high-level with limited supervision and effectively partner with team members when necessary.
• Ability to exercise critical thinking skills in selecting methods, techniques, and evaluation criteria.
• Ability to develop strong relationships with investigative sites.
• Excellent verbal and written communication skills and a demonstrated ability to communicate clearly and professionally.
• Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
• Ability to read, understand and abide by company procedures. Ability to define problems, collect data, establish facts, draw valid conclusions and report on findings.
Benefits
• medical
• prescription drug
• dental and vision insurance
• flexible spending accounts
• participation in 401(k) savings plan
• various paid time off benefits, such as PTO, short- and long-term disability and parental leave
Apply To this Job