Senior Clinical Research Associate

Proclinical is seeking a remote Senior Clinical Research Associate. This individual will manage, deliver and/or perform full clinical site monitoring services for one or more projects, which may include multiple services, be complex in nature and/or run on a multinational scale.

Job Responsibilities:

• Monitoring - Subject Expert: Act as subject matter expert, mentor, coach and/or provide performance feedback to manager for peers.
• Assist with selection, hiring, training, and supervision of CRAs as needed. Perform comonitoring and training visits with CRAs.
• When required, act as the first escalation point for the resolution of site/patient issues or to address Sponsor concerns.
• May represent Director, Monitoring and Site Management or Manager, Clinical Site Management in BD initiatives with a site monitoring focus.
• Project Monitoring Lead - May be assigned Lead CRA role and manage monitoring services for a group of projects and/or CRAs on large/complex project(s) including directing/guiding day to day activities and review/approval of monitoring reports.
• Function as liaison between CRAs and other functional teams, escalating concerns and issues to management as needed.
• Participate and/or present at study team, kickoff and investigator meetings and act as primary contact to sponsors for all monitoring related issues.
• Site Recruitment and Setup - Identify and recruit site investigators, coordinate the movement and delivery of trial materials, samples, tests, and forms, including investigational product, protocols, SOPs, CRFs, project documents, forms and support tools.
• Ensure SOPs in place to optimize patient recruitment providing guidance to site teams of inclusion/exclusion criteria.
• Investigational Site Management - Primary clinical site contact: May act as primary contact for any questions or issues that arise from investigational sites.
• Oversee overall integrity of the study to promote positive working relationships with the site and staff.
• Facilitate and support site staff with access to study systems and ensure sites are compliant with project specific training requirements.
• Ensure all site related issues are followed until resolution.
• Coordinate delivery of clinical sites communications, collaborating with project teams, to ensure investigational sites are provided accurate ongoing data, updates, information and feedback on project/regulatory guidelines and objectives throughout the project lifecycle.
• Investigational Site Monitoring - May conduct and document site initiation, routine monitoring and close out visits, reviewing files, forms, and filings to ensure alignment with S.O.P.s, study guidelines and GCP best practices.
• Work with site staff to verify CRF data is consistent with patient clinical source documents.
• Monitor resolve and/or facilitate resolution of queries arising out of regular and/or safety reviews, adverse events, and other data management activities throughout the trial.
• Conduct remote visits\contacts as requested or as needed.
• Assess and manage Investigational Product supply including supply, accountability, and destruction\return status.
• Ensures site staff is trained on all aspects of the study including but not limited to the protocol, study plans and systems.

Skills and Requirements:

• College Diploma/Degree And 4-6 years related experience +substantial on-going job related training
• One or two year post-secondary education certificate (College, Training Institute, Trade school)
• 7-9 years related experience +continuous training and knowledge/skills upgrading
• Health Sciences, Life Sciences or Nursing specialty preferred, or SoCRA and/or ACRP Certification/Designation.
• Financial Resource Management: Some financial responsibility (handling of small cash floats, minimal spending limits, can provide input during department budget creation).
• Degree of Independence: Sets personal pace and content (significant scope for setting pace and action order within the context of tasks to complete).
• Contacts: Large and varied contacts, (deal with many different people internal/external (vendors/customers/unit queries or escalation).
• Communication Complexity: Regular communication, difficult information, some interpretation and/or advice required, sensitivity required e.g. issue escalations, advising other on how to issues or performance discussion.

If you are having difficulty in applying or if you have any questions, please contact Jon Stewart at +442037520318 or j.stewart@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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