Sarah Cannon Network Job - 35297875 | CareerArc
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Company: Sarah Cannon Network
Location: Nashville, TN
Career Level: Associate
Industries: Healthcare, Pharmaceutical, Biotech

Description

Description

SHIFT: Work From Home
SCHEDULE: Full-time

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.

 

Benefits:

  • Student Loan Repayment
  • Tuition Reimbursement/Assistance Programs
  • Paid Personal Leave
  • 401k (100% annual match – 3%-9% of pay based on years of service)
  • Identity Theft Protection discounts
  • Auto, Home, and Life Insurance options
  • Adoption Assistance
  • Employee Stock Purchase Program (ESPP)

 

**This is a Work From Home position and you can be located anywhere in the United States to be eligible for this role.

 

As the Clinical Team Lead (CTL) II, you will be an integral member of the Project Team, having overall responsibility and accountability for the execution and delivery of site management and clinical operations strategy on a regional or global level, as assigned.

  • You 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.
  • You will ensure that all clinical tasks meet client and Sarah Cannon expectations are complete in accordance with the contract, protocol, ICH-GCP guidelines and applicable Standard Operating Procedures (SOPs).
  • You 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.

  • You will oversee planning and tracking of all assigned clinical activity from study start to completion, including investigative site recruitment/feasibility, essential document collection and review
  • You will track performance metrics for the study team (i.e., training, study visits, report and follow-up letter submission, and monitoring), reviewing and tracking enrollment and data entry timelines for sites
  • You will work directly with data management and Clinical Research Associates (CRA) to monitor site accrual and data retrieval, while identifying and assistins CRA and Clinical Project Associate (CPA) teams with resolution of site specific issues
  • Review monitoring reports and track ongoing site issues
  • You will conduct monitoring and/or co-monitoring visits as determined by project needs and previous experience and training as a CRA
  • You will ensure TMF is set-up by CPA and maintained from study start to completion, perform regular audits of TMF documents
  • As delegated by CPM, you will develop project status reports and communicate with all applicable team members in and outside the organization
  • You 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
  • You will 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
  • You may be required to travel up to 20% for meetings, site visits, and/or attendance at conferences.

Qualifications

For this role, you must have:

  • A Bachelor's Degree (4 year program)
  • At least 1 year of previous experience as a Clinical Team Lead, Clinical Trial Manager, or equivalent role
  • 2 years previous experience as CRA with Lead CRA experience 
  • 2 years direct oncology experience in Phases l – II as a CRA 

It is preferred that you have:

  • A Bachelor's Degree (4 year program)
  • 3-5 years previous experience as a Clinical Team Lead, Clinical Trial Manager, or equivalent role or 
  • 3-5 years previous experience as CRA with Lead CRA experience 
  • 3 years direct oncology experience in Phases l – II as a CRA   
Do you find this opportunity compelling, if so we encourage you to apply? We promptly review all applications. If you are highly qualified you will hear from one of our recruiters. We are actively interviewing so apply today.   We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Notice

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