Clinical Research Associate

Position Title: Clinical Research Associate

Reports to: Associate Director, Clinical Operations

Status: Regular, Full-time, Exempt

Summary: We are seeking a highly motivated Clinical Research Associate (CRA) to be responsible for supporting the Clinical Development Team to ensure the execution of assigned trials according to the study timelines and company goals and in compliance with ICH GCP, country regulations, and SOPs. Your primary role involves oversight of CRO investigative site management activities from the Sponsor perspective (ie, in-house CRA responsibilities). You will not conduct on-site monitoring activities and there is very little to no travel involved. This role will provide you with the opportunity to expand your knowledge and experience in clinical research and management of clinical trials.

Specific responsibilities include, but are not limited to:

• Contributing to the development of the Clinical Operations SOPs, best practices, work instructions, tools, and templates.

• Training and mentoring Clinical Trial Associates.

• Reviewing protocol/amendment for operational aspects, discrepancies, and quality.

• Preparing/updating and participating in the review of study documents and in relation to the study protocol/amendment.

• Supporting the conduct, management, and completion of assigned clinical trials under the leadership and guidance of the Clinical Study Lead.

• Partnering with team members and other functional areas including Regulatory Affairs, Clinical Pharmacology, Clinical Development, Quality Assurance, Legal, Data Management and Biostatistics to perform study related activities.

• Providing accurate and up-to-date information including study status reports to the study team members.

• Timely issue escalation to Clinical Study Lead and assisting with the resolution of issues.

• Sample tracking and reconciliation.

• Assisting in development and formatting of study related documents/spreadsheets.

• Following study timelines to meeting deadlines for assigned tasks.

• Participating in study start-up activities including vendor RFPs and vendor selection.

• Assisting with review and tracking of vendor scope of work and invoices.

• Generating Purchase Orders.

• Assisting with aspects of vendor management under guidance.

• Cultivating and maintaining excellent working relationships with study vendors.

• Assisting in oversight of CRO clinical monitoring activities and the overall site management including ensuring compliance with project-specific plans, Good Clinical Practices (GCP) and applicable regulations and tracking of site performance metrics.

• Overseeing implementation of training of Investigator/site staff.

• Assisting in the management of the ongoing filing of study documents to the TMF including performing periodic QC of assigned sections of the TMF and providing TMF support & guidance for CTA.

• Assisting with study start-up activities including feasibility, site qualification, site selection, and site initiation.

• Negotiating site budgets (as applicable).

• Overseeing status of site payments planned vs. actual.

• Supporting medical monitor with addressing safety related questions.

• Ensuring protocol deviations are appropriately classified and documented, and followed-up on, in collaboration with CRO and medical monitor.

• Supporting Data Management in escalation of CRF queries to vendors/sites/CRO to ensure resolution of findings.

• Supporting IP Accountability activities.

• Collaborating with Regulatory Affairs to ensure the Essential Document Packet is accurate and complete.

• Possibly assisting Quality Assurance with resolution of site and vendor quality event Corrective Actions and Preventative Actions (CAPA).

• Assisting in planning and organizing Investigator Meetings including development and review of investigator meeting material and possibly presenting at investigator meetings.

Qualifications include:

• Bachelor's degree with 2-3 years relevant experience, or master's degree with 1 year of relevant experience

• Knowledge of clinical trial processes, medical terminology, and ICH GCP guidelines

• Experience with Trial Master File management according to the DIA reference model

• Experience using eTMF, EDC, IRT, CTMS, and other vendors systems/portals

• Clear and concise verbal and written communication skill, including English fluency, and strong organizational skills

• Ability to multi-task, prioritize, track projects, and follow-through on-time with assigned tasks

• Exceptional attention to detail

• Ability to work independently and as part of a team

• Proactive; applies critical thinking to improve execution of study tasks

• Ability to learn quickly and effectively using newly acquired skills

• Willingness to embrace change and work in a changing environment

• Ability to work collaboratively across cultures and geographies

• Proficiency in Microsoft Outlook, Word, PowerPoint, Excel

Pay Range:

$111,000 - $123,000

About Assembly Bio

Assembly Bio (NASDAQ: ASMB) is an ambitious biopharmaceutical company with cutting-edge therapeutic clinical candidates capable of improving the lives of millions living with chronic hepatitis B virus (HBV) infection around the world, and research and preclinical programs focused on the discovery of novel antivirals to treat devastating viral diseases, including HBV, hepatitis delta virus (HDV) and herpesviruses.

We pride ourselves on creating a culture and work environment that is scientifically driven, ambitious, and collaborative. We encourage diversity of thought that leads to great innovation and are looking to add great people to our dynamic team who are driven to transform the lives of patients. We set our sights high-and pursue our goals with determination. Our unique organization stands ready to welcome talented, motivated individuals, who share our ambitions.

As an equal opportunity employer, we are committed to diversity and inclusion and will not tolerate discrimination and harassment of any kind. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate.

Information for Recruitment Agencies

Assembly Bio does not accept from recruiters/agencies any unsolicited resumes, or any candidate information including blinded resumes and will not be responsible for any fees related to resumes or candidate information that is unsolicited. Please do not contact hiring managers or Assembly Bio employees directly with any information related to a resume or a candidate. We handle all recruiting through our internal Human Resources team, and we will reach out to you directly should we wish to engage in a search.