Clinical Site Manager

Artech Information System LLC; Fort Worth (TX); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading IT staffing firm is seeking a Clinical Research Associate to implement and execute phase I-III clinical trials. The role involves ensuring compliance with regulations, collaborating with Clinical Study Teams, and developing new clinical investigator sites. Ideal candidates will have at least nine years of experience, proficiency in Microsoft Office, and experience with EDC and Clinical Trial Management Systems. This position requires travel of approximately 60% and strong communication skills.

Qualifications

• Minimum of nine years related experience.
• Five years of direct regional field clinical monitoring/research.
• Currently working in regional position from established home office is preferred.

Responsibilities

• Implement and execute client’s phase I-III clinical trials.
• Ensure compliance with regulations, guidelines, and policies.
• Support budget and contract negotiation with investigational sites.
• Collaborate with Clinical Study Teams to resolve site issues.
• Train and qualify sites and Principal Investigators.

Skills

Microsoft Office proficiency

Electronic Data Capture (EDC) System Experience

Clinical Trial Management System Experience

Excellent verbal and written communication

Problem-solving skills

Team orientation

Education

Degree in Medical, Pharmaceutical, Biology, Chemistry or RN

Tools

Medidata RAVE

Medidata CTMS

Job description

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.

Job Description

• Successfully implements and executes client s phase I III clinical trials at their assigned sites
• Ensures compliance with regulations, guidelines and policies for studies implemented at their assigned sites.
• Supports budget and contract negotiation with investigational sites, as applicable, at their assigned sites; ensures payment for services.
• Ensure recruitment strategies in place to meet study needs, including patient enrollment targets at their assigned sites.
• Collaborates with Clinical Study Teams and within GCSM to identify and resolve site, quality or study execution issues.
• Manage existing sites and develops new clinical investigator sites to meet client projected patient recruitment needs in their region. Works with Regional Manager to:
  • Monitor site quality and performance (metrics); develop solutions to optimize performance.
  • Monitor site availability, commitments, infrastructure and capabilities.
  • Ensure all safety issue are communicated and managed by Principal Investigator and study team in timelines appropriate to the regulatory and protocol requirements.
  • Develop and implements effective corrective action plans for all quality issues identified at assigned sites.
  • Actively participates with study team to stay current with study needs, communicating as needed with sites within defined timelines.
  • Train and qualify sites and Principal Investigators.
  • Develop sites to optimally conduct studies.
• Maintain thorough knowledge of country regulations with special focus on regulatory requirements, guidance documents, and standards relating to global clinical trial conduct for medical devices, pharmaceuticals and biologics, and uses that knowledge to enhance site compliance and performance.
• Performs all monitoring activities according to protocol monitoring plan and relevant WIs
• Maintain / demonstrate knowledge of the protocol, General Monitoring Guidelines (GMG), Protocol Monitoring Plan (PMP) and all protocol specific requirements
• Executes and maintains compliance with all established client processes, procedures, and performance metrics.
• With support of Regional Manager, demonstrates flexibility to meet changes in work environment and study milestones with efficiency, and with strong communication and prioritization skills.
• Builds positive relationship with principal investigators and site personnel under his responsibility.

Qualifications

Skills:

• Microsoft Office proficiency required - Outlook, Excel, Word
• Electronic Data Capture (EDC) System Experience required Medidata RAVE preferred
• Clinical Trial Management System Experience required - Medidata CTMS preferred
• Travel required approximately 60%
• Minimum of nine years related experience
• Five years of direct regional field clinical monitoring / research.
• Currently working in a regional position from an established home office is preferred.
• Excellent verbal and written communication, problem solving skills and team orientation.
• Education:Medical, pharmaceutical, biology, chemistry degree or RN preferred