The Lead Clinical Research Associate (CRA) provides operational expertise and leadership to ensure the effective and efficient delivery of clinical site monitoring on clinical trials. The Lead CRA is the key representative for clinical monitoring on the Study Team and under the direction of the Clinical Project Manager (CPM) they provide leadership and direction to the assigned site monitors throughout the lifecycle of a study. The Lead CRA assesses clinical trial site performance, adequacy of monitoring activities, reviews monitoring visit reports and metrics, and proactively identifies and communicates site management and monitoring issues and risks to the PM. The Lead CRA ensures the monitoring activities of their assigned study(s) are in accordance with SMPA policies and procedures, ICH/GCP and local regulations. The Lead CRA will report directly to the Director of Clinical Operations

Key Responsibilities:

·      The Lead CRA is responsible for;

• Guiding and leading the site monitoring team, to ensure study deliverables are met with efficiency and quality

• Reviewing visit reports and metrics per SOP timelines, noting detail and frequency of protocol deviations and quality and duration of follow-up items, to evaluate for compliance and trends, issue escalation, and involved in the development of corrective and preventive actions, as needed

• Regularly reviewing clinical data (e.g., electronic case report forms, central laboratory data, etc.) to ensure the site monitors are informed and managing their sites’ data and patient samples, as efficiently as possible

• Ensuring site monitors maintain their sites as inspection ready, including the Trial Master File (TMF), for health authority inspections, at all times

• Communication of project timelines and deliverables, as they relate to monitoring

• Develops and maintains the Clinical Monitoring Plan in collaboration with the Clinical Project Manager

• Organizes training with the CPM and site monitors on the study and ensures study training compliance is maintained

• Ensures protocol deviation details are recorded per SOP and team guidance; facilitates team review of protocol deviations

• Develops report annotations in collaboration with the CMP

•     May contribute to the development of EDC and IRT guidance document and provide input with forms development.​
• Coordinates and assists in conducting, with the CPM, regular meetings with the site monitoring team and with individual site monitors, if needed, to disseminate timely and relevant updates and best practices for consistency and efficiency·      
• Attends project meetings and provide monitoring updates·      
• Conducts co-monitoring visits or other monitoring visits (site qualification visit, site initiation visit, interim monitoring visit, or close-out visit), as required by study needs
• Collaborates with the Sr. Clinical Research Manager on developing and updating best practices and processes.·      
• Works independently, able to make knowledge-based decisions, and is aware of when and to whom to escalate issues·      
• Maintains multi-directional communication between Clinical Project Manager, site monitors, and other members of the study team·      
• Serves as a mentor to site monitors with less experience. Helps others develop expertise and skills

Professional Experience/Qualifications:

·       ·       Bachelors or equivalent degree, preferably in life sciences, medicine, or related discipline. RN or equivalent experience will be considered.

·       Minimum of  6 years clinical site monitoring, as a senior level CRA preferably in oncology. This experience should be recent.

·       Willing to travel, as required, in support of monitoring team

·       Thorough knowledge of clinical operations, clinical development process,  ICH/GCP and regulatory environment

·       Ability to serve as a mentor, coach, and trainer for assigned site monitors

·       Excellent oral and written communication skills in English, including proficient presentation skills

·       Proficiency in Microsoft Outlook, Word, Excel, and PowerPoint

·       Proficiency in, and ability to learn new, clinical systems including EDC, IVRS, CTMS, eTMF and other clinical project management tools required

·       Excellent critical thinking and problem-solving skills required

·       Ability to self-motivate, work both independently and collaboratively within a team, proactively manage workload, and manage competing priorities in a fast-paced environment

·       Ability/flexibility to work with sites, monitors and study teams, across multiple time zones

The base salary range for this role is

Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state.  Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter.  Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Confidential Data: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential, in accordance with applicable law.

Compliance: Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Mental/Physical Requirements:

Fast-paced environment handling multiple demands is involved. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.

Travel Requirements:

Primarily remote role with periodic on-site meetings in office. Must be able to travel domestically and internationally as needed.

Drug Screening Requirements
Applicants for sales/field, manufacturing, or other designated roles will be required to submit to a pre-employment drug test.