Location

Greater Boston area

Role Description

Acumen Pharmaceuticals is searching for a Senior Clinical Research Associate (CRA) to join our Clinical Operations team to implement and monitor clinical study activities to ensure the successful execution of our trials in compliance with good clinical practices (GCPs), regulatory compliance, standard operating procedures (SOPs), and study protocols. This position works closely with a cross functional team, vendors, sites, and Clinical Research Organizations (CRO) to ensure compliance with the protocol(s) and the overall clinical objective.

Responsibilities

• Supports the Clinical Operations Lead in managing site performance and addressing site issues to align with project goals and timelines.
• Conducts comprehensive co-monitoring visits (PSVs, SIVs, IMVs, COVs) with CRO to ensure compliance with the clinical trial protocol, SOPs, ICH-GCP, and other regulatory requirements.
• Reviews monitoring visit reports for all visit types and ensures reporting compliance of the Monitors in the region if delegated.
• Coordinates resolution of site audit findings.
• Provides regular updates to internal stakeholders on trial progress, CRO performance relating to site monitoring and site management activities, and any issues or risks that may impact study deliverables.
• Supports the Clinical Operations Leads in maintaining and/or monitoring project timelines and participant enrollment and implementing respective corrective and preventive measures.
• Supports the development and review of study materials, including CRFs and informed consent documents.
• Assists with developing training materials and support; leads site training sessions and ensures accurate documentation and data collection in clinical trials.
• Assists with the management and resolution of data queries to maintain data integrity.
• Contributes to the ongoing quality review and final reconciliation of the Trial Master File (TMF).
• Proactively identifies potential risks and issues that may arise with studies, CROs, and vendors, and make recommendations to address in an effective manner.
• Performs clinical supplies and lab sample management with vendors on a country and regional level.
• Reviews essential study documents and supervises reconciliation of study Investigator Site File (ISF) / TMF at site level and country/region level.
• Supports Clinical Operational Lead in budget planning, tracking and reconciliations.
• Contributes to the development of department processes and best practices.
• Adheres to GCP/ICH guidelines and Acumen SOPs.
• Other duties as assigned

Knowledge & Skills

• Excellent organizational, communication, interpersonal, and problem-solving skills. Ability to manage external vendors while working collaboratively in a fast-paced environment
• Must be flexible and able to work in a dynamic, fast paced environment

• Ability to work independently and as part of a team

• Microsoft Office 365 (Word, Excel, PowerPoint, Teams, Outlook, Microsoft Project)
• DocuSign and Adobe
• EDC/RTSM
• eTMF

• Clinical Research certification (e.g., ACRP, SOCRA) is a plus

Requirements

• University/college degree in science
• At least 4 years of clinical research experience, including at least 2 years as a Clinical Research Associate (CRA) within the pharmaceutical/biotech or CRO industry
• Previous experience overseeing or co-monitoring with CROs is highly desirable
• Strong knowledge of clinical trial methodology, GCP, ICH guidelines, and regulatory requirements
• Ability to travel up to 30%

Compensation and Benefits

Competitive base salary, eligibility for an annual incentive bonus and eligibility to participate in company stock option plan. Competitive benefits package including health, dental, vision, life insurance, 401K and flexible time off.

About Acumen Pharmaceuticals

Acumen, headquartered in Newton, MA, with offices in Indianapolis, IN and Charlottesville, VA, is a clinical-stage biopharmaceutical company developing a novel therapeutic that targets toxic soluble amyloid beta oligomers (AβOs) for the treatment of Alzheimer’s disease (AD). Acumen’s scientific founders pioneered research on AβOs, which a growing body of evidence indicates are early and persistent triggers of Alzheimer’s disease pathology. Acumen is currently focused on advancing its investigational product candidate, sabirnetug (ACU193), a humanized monoclonal antibody that selectively targets toxic soluble AβOs. Acumen is currently conducting the ALTITUDE-AD study, a Phase 2, multi-center, randomized, double-blind, placebo-controlled clinical trial currently enrolling at sites in the United States and Canada, with plans for additional study centers in Europe and the UK, following positive results in INTERCEPT-AD, a Phase 1 clinical trial involving early Alzheimer’s disease patients.

Equal Employment Opportunity

Acumen Pharmaceuticals provides equal employment opportunities to all employees and applicants without regard to race, color, religious creed, sex, national origin, ancestry, citizenship status, pregnancy, childbirth, (or related medical conditions, including, but not limited to lactation), physical disability, mental and/or intellectual disability, age, military status or status as a Vietnam-era or special disabled veteran, marital status, registered domestic partner or civil union status, gender (including sex stereotyping and gender identity or expression), medical condition (including, but not limited to, cancer related or HIV/AIDS related), genetic information, sexual orientation or any other characteristic protected by applicable federal, state and local law.

Accommodation Of Disabilities

Acumen Pharmaceuticals is committed to providing reasonable accommodation for qualified applicants and employees with a disability (including veterans with a disability), unless such accommodation would cause an undue hardship.