Clinical Team Lead
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Clinical Team Lead II - Work From Home
Sarah Cannon Development Innovations is a full-service contract research organization (CRO) that is uniquely focused in oncology. Sarah Cannon Innovations offers strong scientific leadership, access to patients through Sarah Cannon Research Institute's Site Management Organization (SMO) and relationships with other clinical sites, and experience in drug development and delivery of clinical trials from First-In-Man through registration level studies, making us the partner of choice for oncology.
Our differentiator is strong operational delivery in partnership with our Site Management Organization and physician leaders to deliver your program efficiently.
Sarah Cannon Development Innovations works with Sarah Cannon Research Institute strategic and network sites throughout the United States, along with investigators at sites outside of the Sarah Cannon Research Institute network. This reach allows Sarah Cannon Development Innovations to offer sponsors access to a diverse and varied patient population, spanning multiple tumor types and disease stages. These relationships further enhance the depth and breadth of Sarah Cannon Development Innovations' therapeutic expertise, enabling it to provide focused, strategic operational support. This support ensures that clinical trials are conducted in a timely manner and reported with high-quality, registration-standard data.
Sarah Cannon,the global cancer enterprise of Hospital Corporation of America (HCA), offers integrated cancer services with convenient access to cutting-edge therapies for those facing cancer in communities across the United States and United Kingdom.
**This is a Work From Home position and you can be located anywhere in the United States to be eligible for this role.
Summary of Position:
The Clinical Team Lead (CTL) is a member of the Project Team and has overall responsibility and accountability for the execution and delivery of site management and clinical operations strategy on a regional or global level, as assigned. The CTL will work closely with the Project Manager to facilitate collaboration between Sarah Cannon Development Innovations project teams, research sites and clinical trial sponsors to advance common interests and achieve mutual goals. Ensure that all clinical tasks meet client and Sarah Cannon expectations and are completed in accordance with the contract, protocol, ICH-GCP guidelines and applicable Standard Operating Procedures (SOPs). Provide leadership and expertise to ensure successful execution of site selection, study operations, and management of clinical deliverables.
The CTL II will oversee investigator-initiated and/or sponsor trials from implementation to completion with a key focus on managing project timelines for clinical deliverables, oversight of investigative sites, and working with cross-functional teams on data collection and site management.
The CTL II will follow standard operating procedures, ICH-GCP, and all applicable regulatory requirements.
Duties and Responsibilities
Duties include but are not limited to:
- Oversee planning and tracking of all assigned clinical activity from study start to completion
- Oversee investigative site recruitment/feasibility, essential document collection and review
- Create and maintain clinical deliverables and plans (i.e., Visit Report and Letter Templates, Monitoring Plan, Recruitment Plan, etc.)
- Work with Project Manager to develop, maintain, and implement applicable study plans, train staff, and ensure adherence to plans
- Set-up clinical trial monitoring systems and study tools
- Track performance metrics for the study team (i.e., training, study visits, report and follow-up letter submission, and monitoring)
- Review and track enrollment and data entry timelines for sites
- Work directly with data management and Clinical Research Associate (CRA) to monitor site accrual and data retrieval
- Identify and assist CRA and Clinical Project Associate (CPA) teams with resolution of site specific issues
- Review monitoring reports and track ongoing site issues
- Provide regular site specific clinical status information to team members and project management
- Conduct monitoring and/or co-monitoring visits as determined by project needs and previous experience and training as a CRA
- Conduct CRA team meetings
- Ensure TMF is set-up by CPA and maintained from study start to completion, perform regular audits of TMF documents
- Assist with vendor management
- As delegated by CPM, develop project status reports and communicate with all applicable team members in and outside the organization
- Attend project meetings, conference calls and monthly staff meetings as required
- Initiate improvements, tools and forms to enhance the efficiency and the quality of the work performed on assigned projects
- May oversee and coordinate the implementation of projects; developing timelines and quality guidelines, coordinate team efforts on trial meeting deadlines and trial milestones depending on trial complexity or stage
- Create a variety of reports, documents, training tools, and correspondence as needed to assist participating trial sites and for internal purposes in the ongoing monitoring and evaluation of the projects progress
- Communicate and escalate unresolved issues at the appropriate time and to the appropriate level of management
- Other responsibilities as delegated by the CPM
- Travel may be required, up to 50%. May also involve travel to meetings, sites, or attendance at conferences. Overnight stays may also be required. In addition, weekend and evening sessions may be required depending upon the workload and nature of current programs
- Adhere to professional standards and SOPs established for clinical research
Knowledge: A body of information needed to perform a tasks; May be obtained through education, training or experience
- Knowledge of FDA guidelines and GCP is required
- Strong understanding of clinical trials, study design, ICH/GCP knowledge and training
- Excellent professional writing and communication skills
- Strong computer skills with demonstrated ability using clinical trial databases, electronic data capture, proficient in Microsoft Office software, including Word and Excel, and ability to learn new software if required
- Excellent organizational and prioritizing capabilities
- Resource with heightened analytical abilities and problem solving in a fast paced environment
- Excellent interpersonal skills, detail-oriented, and meticulous
Minimum Qualifications
Education:
Minimum Required: Bachelor's Degree (4 year program)
Preferred: Bachelor's Degree (4 year program)
Experience:
Minimum Required:
- 3 years of experience in clinical research as a CRA or similar research/healthcare professional
- Experience in writing technical documents
- Experience in clinical trial set-up, maintenance, and close-out
- 3-4 years of experience in a clinical trial environment, oncology CRA experience preferred
- Significant experience writing technical documents such as study plans
- Experience in clinical trial set-up, maintenance, and close-out
- Direct oncology experience in Phases I-III
Company Description:
At its founding in 1968, Nashville-based HCA was one of the nation's first hospital companies. Today, we are the nation's leading provider of healthcare services, a company comprised of locally managed facilities that includes about 165 hospitals and 115 freestanding surgery centers in 20 states and England and employing approximately 204,000 people. Approximately four to five percent of all inpatient care delivered in the country today is provided by HCA facilities. Milton Johnson serves as Chairman and Chief Executive Officer of HCA.
About the job
Clinical Team Lead
To see similar active jobs please follow this link: Remote Management jobs
Clinical Team Lead II - Work From Home
Sarah Cannon Development Innovations is a full-service contract research organization (CRO) that is uniquely focused in oncology. Sarah Cannon Innovations offers strong scientific leadership, access to patients through Sarah Cannon Research Institute's Site Management Organization (SMO) and relationships with other clinical sites, and experience in drug development and delivery of clinical trials from First-In-Man through registration level studies, making us the partner of choice for oncology.
Our differentiator is strong operational delivery in partnership with our Site Management Organization and physician leaders to deliver your program efficiently.
Sarah Cannon Development Innovations works with Sarah Cannon Research Institute strategic and network sites throughout the United States, along with investigators at sites outside of the Sarah Cannon Research Institute network. This reach allows Sarah Cannon Development Innovations to offer sponsors access to a diverse and varied patient population, spanning multiple tumor types and disease stages. These relationships further enhance the depth and breadth of Sarah Cannon Development Innovations' therapeutic expertise, enabling it to provide focused, strategic operational support. This support ensures that clinical trials are conducted in a timely manner and reported with high-quality, registration-standard data.
Sarah Cannon,the global cancer enterprise of Hospital Corporation of America (HCA), offers integrated cancer services with convenient access to cutting-edge therapies for those facing cancer in communities across the United States and United Kingdom.
**This is a Work From Home position and you can be located anywhere in the United States to be eligible for this role.
Summary of Position:
The Clinical Team Lead (CTL) is a member of the Project Team and has overall responsibility and accountability for the execution and delivery of site management and clinical operations strategy on a regional or global level, as assigned. The CTL will work closely with the Project Manager to facilitate collaboration between Sarah Cannon Development Innovations project teams, research sites and clinical trial sponsors to advance common interests and achieve mutual goals. Ensure that all clinical tasks meet client and Sarah Cannon expectations and are completed in accordance with the contract, protocol, ICH-GCP guidelines and applicable Standard Operating Procedures (SOPs). Provide leadership and expertise to ensure successful execution of site selection, study operations, and management of clinical deliverables.
The CTL II will oversee investigator-initiated and/or sponsor trials from implementation to completion with a key focus on managing project timelines for clinical deliverables, oversight of investigative sites, and working with cross-functional teams on data collection and site management.
The CTL II will follow standard operating procedures, ICH-GCP, and all applicable regulatory requirements.
Duties and Responsibilities
Duties include but are not limited to:
- Oversee planning and tracking of all assigned clinical activity from study start to completion
- Oversee investigative site recruitment/feasibility, essential document collection and review
- Create and maintain clinical deliverables and plans (i.e., Visit Report and Letter Templates, Monitoring Plan, Recruitment Plan, etc.)
- Work with Project Manager to develop, maintain, and implement applicable study plans, train staff, and ensure adherence to plans
- Set-up clinical trial monitoring systems and study tools
- Track performance metrics for the study team (i.e., training, study visits, report and follow-up letter submission, and monitoring)
- Review and track enrollment and data entry timelines for sites
- Work directly with data management and Clinical Research Associate (CRA) to monitor site accrual and data retrieval
- Identify and assist CRA and Clinical Project Associate (CPA) teams with resolution of site specific issues
- Review monitoring reports and track ongoing site issues
- Provide regular site specific clinical status information to team members and project management
- Conduct monitoring and/or co-monitoring visits as determined by project needs and previous experience and training as a CRA
- Conduct CRA team meetings
- Ensure TMF is set-up by CPA and maintained from study start to completion, perform regular audits of TMF documents
- Assist with vendor management
- As delegated by CPM, develop project status reports and communicate with all applicable team members in and outside the organization
- Attend project meetings, conference calls and monthly staff meetings as required
- Initiate improvements, tools and forms to enhance the efficiency and the quality of the work performed on assigned projects
- May oversee and coordinate the implementation of projects; developing timelines and quality guidelines, coordinate team efforts on trial meeting deadlines and trial milestones depending on trial complexity or stage
- Create a variety of reports, documents, training tools, and correspondence as needed to assist participating trial sites and for internal purposes in the ongoing monitoring and evaluation of the projects progress
- Communicate and escalate unresolved issues at the appropriate time and to the appropriate level of management
- Other responsibilities as delegated by the CPM
- Travel may be required, up to 50%. May also involve travel to meetings, sites, or attendance at conferences. Overnight stays may also be required. In addition, weekend and evening sessions may be required depending upon the workload and nature of current programs
- Adhere to professional standards and SOPs established for clinical research
Knowledge: A body of information needed to perform a tasks; May be obtained through education, training or experience
- Knowledge of FDA guidelines and GCP is required
- Strong understanding of clinical trials, study design, ICH/GCP knowledge and training
- Excellent professional writing and communication skills
- Strong computer skills with demonstrated ability using clinical trial databases, electronic data capture, proficient in Microsoft Office software, including Word and Excel, and ability to learn new software if required
- Excellent organizational and prioritizing capabilities
- Resource with heightened analytical abilities and problem solving in a fast paced environment
- Excellent interpersonal skills, detail-oriented, and meticulous
Minimum Qualifications
Education:
Minimum Required: Bachelor's Degree (4 year program)
Preferred: Bachelor's Degree (4 year program)
Experience:
Minimum Required:
- 3 years of experience in clinical research as a CRA or similar research/healthcare professional
- Experience in writing technical documents
- Experience in clinical trial set-up, maintenance, and close-out
- 3-4 years of experience in a clinical trial environment, oncology CRA experience preferred
- Significant experience writing technical documents such as study plans
- Experience in clinical trial set-up, maintenance, and close-out
- Direct oncology experience in Phases I-III
Company Description:
At its founding in 1968, Nashville-based HCA was one of the nation's first hospital companies. Today, we are the nation's leading provider of healthcare services, a company comprised of locally managed facilities that includes about 165 hospitals and 115 freestanding surgery centers in 20 states and England and employing approximately 204,000 people. Approximately four to five percent of all inpatient care delivered in the country today is provided by HCA facilities. Milton Johnson serves as Chairman and Chief Executive Officer of HCA.