Massachusetts Jobs

The Senior CRA is responsible for monitoring and management of clinical sites. This position focuses on all activities required to evaluate, initiate, monitor and close clinical sites in compliance with the Code of Federal Regulations and ICH/GCP Guidelines. This role also provides operational input to clinical study teams and contributes to department initiatives.

What you will be doing:

• Act as liaison between the in-house team, vendors, and multiple clinical sites.

• Work collaboratively with investigative sites to develop strong, long-term, working relationships.

• Apply SOPs, Clinical Monitoring Plan (CMP), study manuals and other materials and guidelines as applicable.

• Help identify and qualify potential investigators. Perform Pre-Study Site Visits.

• Assist with start-up activities, including essential document review and collection as requested.

• Perform Site Initiation Visits.

• Provide initial and ongoing training to site personnel regarding the study protocol, applicable policies/procedures, and GCP.Performs Interim Monitoring Visits for assigned studies: o Monitor site compliance with study protocol, and GCP.

• Performs Interim Monitoring Visits for assigned studies: o Monitor site compliance with study protocol, and GCP.

• Performs source data review and verify adequacy of clinical data through comparison of case report forms to source documents per CMP.

• Ensures the site is entering data according to the CRF Completion Guidelines and meeting data entry and query resolution deadlines.

• Performs drug accountability and ensure adequate drug supply.

• Reviews research specimen sample documentation, storage and processing and ensure shipments are sent to central lab as required.

• Assists study team as necessary in resolving lab queries and other issues.

• Collaborates with the drug safety group to ensure site compliance with serious adverse event reporting requirements.

• Ensures adequacy of clinical supplies to the site.

• Collects and review site essential documents and ensure site regulatory file is complete and accurate.

• Monitors site compliance with IRB policies/processes and ensure timely submissions and approvals.

• Tracks and reports progress of study, data monitoring, protocol variations, issue resolution, and follow up compliance.

• Ensures site staff is appropriately trained, and site responsibilities are delegated to qualified staff.

• Performs Close Out visits as assigned.

• Prepares and submits visit trip reports, confirmation and follow up letters within timelines outlined in the CMP.

• Tracks, reports, and follows all action items to resolution.

• Maintains CTMS in a timely fashion, utilizing available reports and study tools.

• Worksproactively with sites to address site issues and action items to obtain swift resolution and escalate to PL/PI per CMP.

• Assists data management as required.

• Provides co-monitoring support as requested.

• Contributes to the preparation and follow-up of on-site Client sponsored quality audits and regulatory authority inspections as assigned.

• Completes routine administrative tasks in a timely manner.

• You are:

• BA/BS, or equivalent, or relevant experience and training with at least 6 years of pharmaceutical/biotech experience. RN or health care professional preferred.

• Prior monitoring experience is required. Oncology/hematology clinical trial experience is preferred. FDA/EMA inspection experience is preferred.

• Proficiency in CFR and GCP/ICH Guidelines is required. Experience working on global clinical trials is preferred.

• Proficiency in Microsoft Office Products (Word, Excel, PowerPoint, SharePoint) and other electronic systems (CTMS, EDC and eTMF).

• Excellent communication and organizational skills. o Ability to discuss scientific, medical and therapeutic area information within small and large groups of medical professionals.

• Ability to proactively handle multiple tasks, manage a diverse range of functional activities, prioritize workload and solve problems simultaneously.

• Flexibility towards work assignments, learning, and travel.

• Able and willing to travel approximately 55-75%. Travel requirements will vary depending on study requirements, site assignments, site remote monitoring capabilities, and geographical location.

• Highly responsive and proactive, a team player Why ICON? Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.