Viridian Therapeutics, Inc.
Senior Clinical Trial Associate
Viridian Therapeutics, Inc., Waltham, Massachusetts, United States, 02254
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Senior Clinical Trial Associate
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Viridian Therapeutics, Inc. At Viridian, we aim to advance new treatments for patients underserved by today’s therapies. Our team consists of talented, entrepreneurial-minded professionals dedicated to improving the lives of patients suffering from serious diseases. We strive for data-driven decisions, strategic risk-taking, and efficient use of time and funds to best position our ideas for success. We value thoughtful ideas, open communication, and transparency, and are committed to a culture that allows employees to contribute at a high level, grow their careers, and balance their personal and professional ambitions. Reporting to the Director, Clinical Operations, the Senior Clinical Trial Associate (Sr. CTA) is a critical member of the project team. The CTA assists the Clinical Operations Team with all aspects in the administration relating to clinical trial conduct according to International Conference of Harmonization (ICH), Good Clinical Practice (GCP), Code of Federal Regulations (CFR) and company Standard Operating Procedures (SOP). The CTA assists the Clinical Operations Team with the management of clinical studies from study implementation (start-up) to study close-out. Some or all of the responsibilities may be delegated to a Contract Research Organization (CRO). This role is based in our Waltham, MA headquarters. Our office-based employees are required to work in the office three (3) days a week. Responsibilities
Maintain the Trial Master File (TMF), assist with site management, initiate the distribution, collection, handling, reviewing, tracking and archiving of essential documents throughout the lifecycle of clinical studies; this includes managing the filing indexes and maintaining current lists of correspondence; ensures completeness of, conducts regular audits of, organizes and archives clinical Trial Master File documents, including clinical study site documents, email correspondence, training materials and other study documents; participates in TMF or study audits as request and assists with responding to findings Assist the study teams with site communications for various purposes – this includes feasibility/site identification activities and site updates Perform study start-up activities which includes but is not limited to review of informed consents, development and review of study reference plans and manuals; distribute, collect and conduct quality review of clinical study site documents Submit study documents to ethics committee and/or competent authorities; work as a liaison with review boards and independent ethics committees in the regulatory approval process Assist with the creation and maintenance of study-specific documents, tools and materials and the procurement of study supplies Provide study materials and supplies to the study sites and Clinical Research Associates (CRAs) Assist with tracking of clinical study progress including the creation and maintenance of study related trackers and status reports Participate in clinical team meetings – coordinates teleconferences / webinar and assists with the preparation of agendas, minutes and tracking of action items Prepare for and attend Investigator Meetings, as required. May participate in clinical vendor selection process, as required Perform review of clinical data listings, as required Under general supervision, manage third party vendors in the everyday conduct of a clinical trial (central lab, reading center, IRB) Maintain completion of company and study-specific trainings such as SOPs, policies, study plans and documents by due date May participate and contribute to the implementation of process improvements to support study teams, department or the company (e.g. SOPs) Assist with other duties and projects, as needed Qualifications
Requires an undergraduate degree or its international equivalent in clinical, science or health-related field with a minimum of 3 years' clinical research experience with a pharmaceutical, biotechnology, or contract research organization (CRO) Outstanding interpersonal skills coupled with the ability to communicate effectively in both oral and written form Demonstrate high ethical standards for honesty, truthfulness and integrity Knowledge of applicable FDA Code of Federal Regulations, Good Clinical Practices, and ICH guidelines, as well as basic understanding of the phases of clinical drug development and clinical operation processes Ability to receive general instructions on all new assignments and perform routine work with minimal or no supervision. Strong sense of urgency, organizational skills with attention to detail and ability to follow through on assigned tasks Proficiency in computer literacy in several software packages, especially Microsoft Office applications (Word, Excel) and database software (eTMF, EDC) to support operation of clinical trial databases and electronic filing methods Enthusiastic team player and ability to work effectively in a team/matrix environment Ability to handle multiple tasks and deliver assigned tasks with quality and within specified timelines Strong commitment to ethical standards Ability to travel as needed The salary range for this position is commensurate with experience Benefits
Competitive pay and stock options for all employees Medical, dental, and vision coverage with 100% of premiums paid by Viridian for employees and their eligible dependents Fertility and mental health programs Short- and long-term disability coverage Life, Travel and AD&D 401(k) Company Match with immediate company vest Employee Stock Purchase plan Generous vacation plan and paid company holiday shutdowns Various mental, financial, and proactive physical health programs covered by Viridian EEO Statement
Viridian Therapeutics, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination, harassment, or retaliation of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by Federal, State, and Local laws. Viridian will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Viridian Therapeutics, Inc participates in E-Verify, the federal program for electronic verification of employment eligibility. Seniority level
Associate Employment type
Full-time Job function
Research and Science Massachusetts, United States $34.00 - $51.25 1 week ago Waltham, MA $155,000.00 - $180,000.00 6 months ago
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Senior Clinical Trial Associate
role at
Viridian Therapeutics, Inc. At Viridian, we aim to advance new treatments for patients underserved by today’s therapies. Our team consists of talented, entrepreneurial-minded professionals dedicated to improving the lives of patients suffering from serious diseases. We strive for data-driven decisions, strategic risk-taking, and efficient use of time and funds to best position our ideas for success. We value thoughtful ideas, open communication, and transparency, and are committed to a culture that allows employees to contribute at a high level, grow their careers, and balance their personal and professional ambitions. Reporting to the Director, Clinical Operations, the Senior Clinical Trial Associate (Sr. CTA) is a critical member of the project team. The CTA assists the Clinical Operations Team with all aspects in the administration relating to clinical trial conduct according to International Conference of Harmonization (ICH), Good Clinical Practice (GCP), Code of Federal Regulations (CFR) and company Standard Operating Procedures (SOP). The CTA assists the Clinical Operations Team with the management of clinical studies from study implementation (start-up) to study close-out. Some or all of the responsibilities may be delegated to a Contract Research Organization (CRO). This role is based in our Waltham, MA headquarters. Our office-based employees are required to work in the office three (3) days a week. Responsibilities
Maintain the Trial Master File (TMF), assist with site management, initiate the distribution, collection, handling, reviewing, tracking and archiving of essential documents throughout the lifecycle of clinical studies; this includes managing the filing indexes and maintaining current lists of correspondence; ensures completeness of, conducts regular audits of, organizes and archives clinical Trial Master File documents, including clinical study site documents, email correspondence, training materials and other study documents; participates in TMF or study audits as request and assists with responding to findings Assist the study teams with site communications for various purposes – this includes feasibility/site identification activities and site updates Perform study start-up activities which includes but is not limited to review of informed consents, development and review of study reference plans and manuals; distribute, collect and conduct quality review of clinical study site documents Submit study documents to ethics committee and/or competent authorities; work as a liaison with review boards and independent ethics committees in the regulatory approval process Assist with the creation and maintenance of study-specific documents, tools and materials and the procurement of study supplies Provide study materials and supplies to the study sites and Clinical Research Associates (CRAs) Assist with tracking of clinical study progress including the creation and maintenance of study related trackers and status reports Participate in clinical team meetings – coordinates teleconferences / webinar and assists with the preparation of agendas, minutes and tracking of action items Prepare for and attend Investigator Meetings, as required. May participate in clinical vendor selection process, as required Perform review of clinical data listings, as required Under general supervision, manage third party vendors in the everyday conduct of a clinical trial (central lab, reading center, IRB) Maintain completion of company and study-specific trainings such as SOPs, policies, study plans and documents by due date May participate and contribute to the implementation of process improvements to support study teams, department or the company (e.g. SOPs) Assist with other duties and projects, as needed Qualifications
Requires an undergraduate degree or its international equivalent in clinical, science or health-related field with a minimum of 3 years' clinical research experience with a pharmaceutical, biotechnology, or contract research organization (CRO) Outstanding interpersonal skills coupled with the ability to communicate effectively in both oral and written form Demonstrate high ethical standards for honesty, truthfulness and integrity Knowledge of applicable FDA Code of Federal Regulations, Good Clinical Practices, and ICH guidelines, as well as basic understanding of the phases of clinical drug development and clinical operation processes Ability to receive general instructions on all new assignments and perform routine work with minimal or no supervision. Strong sense of urgency, organizational skills with attention to detail and ability to follow through on assigned tasks Proficiency in computer literacy in several software packages, especially Microsoft Office applications (Word, Excel) and database software (eTMF, EDC) to support operation of clinical trial databases and electronic filing methods Enthusiastic team player and ability to work effectively in a team/matrix environment Ability to handle multiple tasks and deliver assigned tasks with quality and within specified timelines Strong commitment to ethical standards Ability to travel as needed The salary range for this position is commensurate with experience Benefits
Competitive pay and stock options for all employees Medical, dental, and vision coverage with 100% of premiums paid by Viridian for employees and their eligible dependents Fertility and mental health programs Short- and long-term disability coverage Life, Travel and AD&D 401(k) Company Match with immediate company vest Employee Stock Purchase plan Generous vacation plan and paid company holiday shutdowns Various mental, financial, and proactive physical health programs covered by Viridian EEO Statement
Viridian Therapeutics, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination, harassment, or retaliation of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by Federal, State, and Local laws. Viridian will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Viridian Therapeutics, Inc participates in E-Verify, the federal program for electronic verification of employment eligibility. Seniority level
Associate Employment type
Full-time Job function
Research and Science Massachusetts, United States $34.00 - $51.25 1 week ago Waltham, MA $155,000.00 - $180,000.00 6 months ago
#J-18808-Ljbffr