Description:

Site Management/Monitoring

• Perform routine and complex on-site and in-house site assessment for approximately 30-50 clinical sites with minimal to no guidance. Act as primary study contact and guide site through study procedures.
• Review and approve site-specific Informed Consent Form templates.
• Manage and oversee continuing regulatory, contract completion and trial process work by CRA 1 through trial close-out.
• Independently assess protocol and regulatory compliance, including but not limited to source document verification, informed consent process and human subject protection, data integrity, drug accountability and compliance, and review of investigator and regulatory files.
• Identify and report deviations from protocol, regulations and SOPs.
• Identify action items and discuss with appropriate site personnel. Document ongoing follow-up and resolution. Coach site personnel to improve performance.
• Identify when issues require escalation. Implement and work with sites on corrective action plans to address compliance issues.
• Oversee and ensure distribution of appropriate forms, supplies, equipment and investigational product and receipt by site according to established trial timelines.
• Regularly review and update study and site status information into required systems to maintain accurate, current reports.
• Routinely communicate study expectations and progress with sites.
• Document essential trial site management and monitoring activities and site communication, electronic and hard copy, with minimal to no guidance. Utilize monitoring tools and trial documents.
• Recommend revisions to improve efficiencies of monitoring tools, trial documents and study processes. Independently develop study-specific versions.
• Work with sites to ensure data collection, entry and cleaning are complete, and that benchmarks/timelines for completion are maintained with minimal to no guidance. Provide training, assistance and follow up for appropriate query resolution and source documentation. Review data status reports to observe trends and progress.
• Use knowledge of protocol to interpret data and work with other functional groups and sites to resolve clinical data issues.

Study Organization

• Assess adequacy of site personnel and facilities for study conduct.
• Work closely with study sites to complete study start-up by facilitating site regulatory document completion, regulatory approval and readiness to participate.
• Negotiate and complete contract process.

Study Training

• Provide initial and ongoing study training and guidance to designated site personnel for conducting study in accordance with protocol, SOPs, trial specific procedures and applicable regulations via Investigator meetings, WebEx, telephone and email.
• Identify situations that may affect patient safety, data integrity or study processes and retrain site personnel accordingly.

Trial Conduct

• Build and maintain effective working relationships with site personnel, internal and external study contacts by utilizing an assertive, business-like manner which fosters study compliance and promotes confidence in the company.
• Contribute to positive team dynamics through effective listening and communication, sharing information and proactively identifying problems and resolutions.
• Routinely communicate with internal partners as needed for trial activities.
• Act as point person for trial-specific activities. Participate in special assignments as requested by supervisors.
• Provide routine and complex reports to ensure timely communication regarding status of sites, study issues and resolutions, and trial activities, with minimal to no guidance.
• Serve as mentor/coach for all assigned CRA 1 and Clinical Trial Assistant (CTA) personnel, and provide input for performance evaluations.
• Serve as resource to other team members for day-to-day trial activities. Participate as trainer and mentor. 
• Develop training materials and study tools.

Administrative

• Maintain job knowledge and skills through required, recommended and independent ongoing study and training.
• Attend team, functional group and company meetings.
• Complete administrative activities accurately and in a timely manner; e.g., time tracking, training file.
• Participate in feedback activities for self and others for annual performance evaluations.

Additional Skills & Qualifications:

Ability to monitor study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines

Ability to resolve project-related problems and prioritize workload for self and team

Previous clinical research monitoring experience (including pre-study, initiation, routine monitoring and closeout visits).

Experience Level:

Expert Level

Skills:

CRA, Clinical Research Associate, sites, visits, monitor, Clinical research, Site Initiation

Top Skills Details:

CRA,Clinical Research Associate,sites,visits, monitor,Clinical research

Additional Skills & Qualifications:

- Low travel

- Prior experience with nephrology study experience is a plus

- Minimum 5 years of on-site/remote monitoring experience required

- Must have solid Site Initiation experience

- 4 year degree required or equivalent experience

Experience Level:

Intermediate - Expert Level

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.