Senior Clinical Team Lead - Work From Home
Location:
Nashville , Tennessee
Posted:
December 12, 2017
Reference:
25319-4380
Senior Clinical Team Lead - 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 Sr. Clinical Team Lead will work closely with Clinical Project Managers 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, project plans, ICH-GCP guidelines and applicable Standard Operating Procedures (SOPs). Provide leadership in the development of clinical trials and related documents.

May oversee the project management and operational responsibilities essential to the successful management and completion of multiple assigned complex clinical research trial projects from implementation to completion with a key focus on meeting project timelines, oversight of investigative sites and working with cross-functional teams on quality data collection.

The Sr. CTL will follow standard operating procedures, ICH-GCP, and all applicable regulatory requirements.

The Sr. CTL is an essential member of a Development Innovations project team responsible for the execution of a clinical research project. The degree of responsibility given to a Sr. CTL shall reflect his/her experience and the level of contribution, which he/she can make to that project.

Duties and Responsibilities

Duties include but are not limited to:
  • Assist in planning and tracking of all assigned clinical activity in the lifecycle phases of the startup, interim, and close-out
  • Assist in defining and managing project resource needs and establishing contingency plans for key resources
  • Assist in planning of trial budget, communicating deviations from trial budget projections, and proposing solutions for budget delays and deviations
  • Identifying and presenting project related issues and facilitating resolutions both in and across functions
  • Assist CPM with creation and maintenance of clinical project documents and plans (i.e., Visit Report and Letter Templates, Monitoring Plan, Project Plan, Communication Plan, Recruitment Plan, etc.)
  • Develop and conduct study team training
  • Set-up clinical trial monitoring systems and study tools (i.e., CTMS, study trackers for training, protocol deviations, monitoring visits, reports, letters, etc.)
  • 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 project team to monitor site accrual and data retrieval.
  • Identify and assist project team with resolution of site specific issues
  • May act as CPM depending on trial complexity and/or stage of trial
  • Perform various trial activities including generation of source document worksheets and other
  • tools, oversight of trial enrollment, tracking serious adverse events, protocol deviations and violations, and addressing study questions
  • 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
  • Shared oversight of Trial Master File responsibility
  • Assist with vendor management
  • As delegated by CPM, develop project status reports and communicate with all applicable team members in and outside the organization
  • Review monitoring reports and track ongoing site issues
  • Provide regular site specific clinical status information to team members and project management
  • Initiate improvements to enhance the efficiency and the quality of the work performed on assigned projects
  • Conduct CRA, sponsor, and team meetings as delegated by the CPM
  • Attend project meetings, conference calls and monthly staff meetings as required
  • Conduct monitoring and/or co-monitoring visits as determined by project needs and previous experience as a Sr. CRA
  • Contribute to the departmental on-site Quality Control program by setting a schedule of site assessment visits for the project
  • Ensure awareness of project-specific quality and performance standards (within Development Innovations Monitoring Standards) and ensure that these are adequately documented, communicated, and understood
  • Actively participate in training sessions and workshops, including presenting reports from any conferences attended
  • Attendance at Investigator Meetings
  • Meet with clinical study sponsor representatives, as requested
  • Submission of routine monitoring visit reports and follow-up letters as per required timelines
  • Ensure resolution of issues with investigative sites
  • Travel may be required. May also involve travel to meetings 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
  • Act as a mentor and/or trainer for less experienced CRA and/or project team members
  • Other responsibilities as delegated by the CPM
  • Adhere to professional standards and SOPs established for clinical research
Competencies
Knowledge: A body of information needed to perform a tasks; May be obtained through education, training or experience
  • Knowledge of ICH Guidelines, Good Clinical Practices, and FDA regulations
  • Strong understanding of clinical trials, study design, and drug/device development process
  • Knowledge of scientific, medical, and regulatory terms
Skills: The proficiency to perform a certain task
  • Excellent professional writing and communication skills
  • Strong computer sills with demonstrated ability using clinical trial databases, electronic data capture, proficient in Microsoft Office software, including Work, Excel, and PowerPoint, and ability to learn new software, if required
  • Demonstrated leadership and/or mentoring skills
  • Demonstrated training skills
Abilities: An underlying, enduring trait useful for performing duties
  • 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
  • Ability to manage, organize, and make decisions

Qualifications:
Minimum Qualifications

Education:
Minimum Required: Bachelor's Degree (4 year program)
Preferred: Bachelor's Degree (4 year program)

Experience:
Minimum Required:
  • Previous experience as a Sr. CRA, Clinical Team Lead, or equivalent role
  • 3 years direct oncology experience in Phases I-III
  • Demonstrated leadership skills
  • Prior experience mentoring and/or training less senior team members
Preferred:
  • At least five years direct oncology experience in Phase l - lll in solid and liquid tumor types
  • Three or more years of experience in a Sr. CRA, Clinical Team Lead, or equivalent role
  • Demonstrated leadership skills
  • Prior experience mentoring and/or training less senior team members
  • Experience managing study timelines, deliverables, and/or vendors

**If interested in advancing your career with a growing leader in cancer research please apply today!

A little about us:
HCA is the nation’s leading private provider of healthcare services. Comprised of locally managed facilities which include 230,000 employees at over 160 hospitals, over 120 surgery centers and 100 urgent care facilities in 20 states and the United Kingdom

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