Senior Clinical Research Associate
Veristat is expanding our global footprint, from our home office in Boston, up to Canada, down to RTP, and over to Taipei.
We do things differently than large CROs. Do you value scientific integrity and a collaborative team environment? If so, you will feel right at home here with dedicated opportunities to discuss your achievements and grow your career through quarterly feedback conversations.
We invite you to learn more about us at our website www.veristat.com.
The Senior Clinical Research Associate (“CRA”) has the primary responsibility of ensuring the rights and well-being of human subjects are protected, the reported trial data are accurate, complete, and verifiable from source documents.
In addition, s/he is responsible for overseeing the conduct of the trial, and ensuring that it is compliant with the currently approved protocol (and/or amendments), with Good Clinical Practices, and with the requirements set out by the applicable regulatory agencies. The work done as a Senior CRA will support the success of investigational new drugs or devices, and is a pivotal position in the conduct of all clinical trials.
In this role, the Senior CRA may support clinical trials of increasing complexity, assist with quality activities, assist the project lead, and may support multiple studies simultaneously.
As a Senior CRA You Will...
• Conduct qualification, initiation, interim and close out visits at clinical trial sites
• Document visit activities in the monitoring visit report and communicate progress to site via confirmation and follow up letters, as per monitoring guidelines
• Ensure trial site(s) are in compliance with the study protocol, GCP, SOPs and applicable regulatory requirements
• Conduct source data review/verification according to monitoring plan
• Verify proper subject informed consent process is taking place and appropriate documentation is collected
• Verify eligibility for enrolled subjects
• Regularly review maintenance of required documentation in the Investigator File and/or Regulatory Binder; in addition, provide required documentation to the clinical team/client for the Trial Master File (TMF) or electronic TMF
• Verify staff qualifications (including proper delegation and training) and resources (including facilities and equipment) and ensure that these remain at an acceptable standard throughout the duration of the clinical trial period
• Conduct IP accountability and review storage conditions to ensure compliance
• Review supplies and assist site with ordering additional supplies as needed
• Provide training to site staff on protocol requirements
• Issue and reconcile queries for discrepant data in collaboration with Biometrics
• Review data entry progress and work with site to ensure compliance with timelines
• Discuss recruitment progress, issues and plans to mitigate hurdles and drive enrollment to success
• Identify and discuss study issues and updates with PI and other site staff in a timely manner to ensure the success of the clinical trial
• Report any identified protocol, SOP or GCP deviations and ensure that corrective and preventative measures are implemented to prevent future occurrences, referencing and following internal SOPs for serious breaches of GCP, Fraud or Misconduct
• Actively follow up with sites about pending action items and queries in a timely manner
• May provide input into the development of clinical trial related documents including but not limited to: protocols, case report forms, informed consents, conventions/timelines, monitoring plans, site reference manuals, pharmacy manuals, laboratory manuals, training materials, and initiation slide presentation
• Provide support/follow up to the study team related to IRB submissions and approvals
• May co-monitor study sites, as required
• Maintain study specific tracking via CTMS or other tools
• Liaise with the Safety Department in the management of serious adverse events (SAEs) and reports, and ensure appropriate action is taken at the trial site in accordance with the appropriate Policies, Standard Operating Procedures (SOPs), study specific requirements, as well as current Good Clinical Practice (GCP), International Conference on Harmonization (ICH) and applicable local regulations
• Provide trial site updates and identify risks to project timelines to the PM and/or LCRA according to study specific monitoring guidelines, and in a timely fashion
• Attend project meetings and teleconferences as per monitoring guidelines
• May attend and present at Investigator Meetings
• Assist in the preparation for, and participates in site audits and inspections; assists in responding to any issues identified within the timeframe specified
• Maintain/develop scientific knowledge within the Project’s therapeutic area
• Maintain computer skills required to work efficiently
• Maintain effective and meaningful communication between study site, clinical team, and client to ensure the success of the clinical trial
• Serve as a resource and mentor to more junior CRAs and team members
Experience + Requirements
• Bachelor’s Degree required; degrees in health sciences strongly preferred
• 5 or more years of experience as a CRA in a CRO or Pharmaceutical setting required; Certified Healthcare Professional (e.g. Registered Nurse, Licensed Practical Nurse, MD, etc) strongly preferred
• Knowledge of the clinical research process including ICH/GCP guidelines and federal and local regulations for the United States, Canada, Europe, and the ability to work with requirements for other geographies required
• Proficiency in Microsoft Outlook, Word, Excel, and PowerPoint required
• Proficiency in, and ability to learn new, clinical systems including EDC, IVRS, CTMS, eTMF and other clinical project management tools required
• Excellent oral and written communication skills in English, including proficient presentation skills required; ability to speak and write in other languages a plus
• Excellent critical thinking and problem-solving skills required
• Ability to self-motivate, work collaboratively within a team, proactively manage workload, and manage competing priorities in a fast-paced environment required