7,358 Clinical Trial Assistants jobs in the United States

If you're looking to push the envelope and join an innovative company where technology meets therapeutic discovery and development and you're enthusiastic, creative, with a passion for cutting-edge research and development, you should join our team! We are looking for highly motivated, passionate employees to help us drive technology solutions for discovering breakthrough treatments for our portfolio of rare disease and neuroscience programs, as well as for our partners across major therapeutic areas. Senior Clinical Trial Associate/Clinical Trial AssociateApply Summary of Position Anavex Life Sciences Corp. is seeking talented and highly motivated Clinical Trial Associates (CTA). This role will manage multiple administrative aspects of clinical trials across all project stages, including study start-up, enrollment, study conduct, and close-out. The successful candidate will be a hands-on clinical trial associate capable of performing quality control of clinical trial documents, assisting with study start-up, conduct and close-out of study activities. This individual will have accountability for managing the collection, review, completeness, and quality of the assigned Trial Master File (TMF). Key Responsibilities Central contact for the clinical operations team for designated project communications, correspondence, and associated documentation. Set up and maintain study-specific paper and electronic TMFs. Perform and oversee Quality Control (QC) reviews of essential study documents and TMF to ensure ongoing inspection readiness and compliance with applicable regulations and Good Clinical Practices. Track and report CRO's ability to maintain TMF health metrics on an ongoing basis. Process essential documents and ensure they are correctly filed in the appropriate TMF. Track and report study CRO metrics; inclusive of start-up, data management, and contracting as needed. Participate in GxP audits and related clinical operations compliance and inspection readiness activities. Prepare and track study documents (e.g., contracts, budgets, IRB documentation). Assist with information gathering, literature searches, and creation of presentations, as needed. Maintain and oversee tasks performed by CRO related to databases/spreadsheets, as necessary, to facilitate tracking/documentation of departmental activities (e.g., CRFs, queries, clinical data or sample flow, etc.) Administer user access and change control within Anavex's electronic systems. Assist in User Acceptance Testing (UAT) for all Electronic Data Capture (EDC) needs in regard to Data Management and all Clinical Systems. Assist in ensuring all Systems, including but not limited to, EDC (Data Management), TMF, CTMS, Payments, etc. are best utilized per Quality standards. Assist with vendor management and associated logistics, as assigned. Contribute to the creation of presentations, as needed for project, departmental, sponsor, and/or business development presentations. Collaborate with Associate Director, Clinical Operations, Clinical Supply Unit, and QA in order to manage activities related to Clinical Supplies. Manage study-related payment procedures. Interact with external providers during study conduct (CROs, monitors, and, occasionally, investigators and Hospital personnel) Provide input for budget development and check monthly costs invoiced based on planned study activities vs actual. Participate in the completion and review of Request for Proposals (RFPs) in collaboration with the Clinical Operations Management. Organize and/or participate in meetings with CROs. Ensure appropriate meeting minutes are prepared and filed in TMF. Assist CRAs with the preparation, handling, and distribution of Clinical Trial Supplies and maintenance of tracking information. Assist in creating and implementing departmental SOPs and procedures. The position will be filled at a level commensurate with experience. Requirements BS/BA in Life Sciences or equivalent 3+ years of experience in similar positions in Biotech, Pharmaceutical, or clinical research organization environment Extensive experience managing paper and electronic TMF, including set-up, maintenance, QC/ QR, and query management. Familiar with the DIA reference model Knowledge of ICH/GCP and applicable regulations Demonstrated proficiency in written, verbal and face-to-face communication to effectively present information to and influence the decision-making of managers, and working partners (local and global) Ability to successfully manage multiple tasks and multifunctional resources concurrently while maintaining a high attention to detail and responding to rapidly changing priorities and aggressive deadlines Proficient in MS Office (Word, Excel, Project), Adobe, and ISI Toolbox Strong critical thinking, organizational and time-management skills Ability and willingness to travel (up to 10% of the time) Your Path to Unique Opportunities If you're looking to push the envelope and join an innovative company where technology meets therapeutic discovery and development and you're enthusiastic, creative, with a passion for cutting-edge research, you should join our team! We are looking for highly motivated, passionate employees to help us drive technology solutions for discovering breakthrough treatments for our portfolio of rare disease and neuroscience programs. About Anavex Life Sciences Corp. Anavex Life Sciences Corp. (Nasdaq: AVXL) is a publicly traded biopharmaceutical company dedicated to the development of differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer's disease, Parkinson's disease, Rett syndrome and other central nervous system (CNS) diseases, pain, and various types of cancer. Further information is available at . EOE/M/F/V/SO Anavex Life Sciences Corp. is an Equal Opportunity Employer. All qualified candidates will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, gender identity, sexual orientation or protected veteran status. Visit anavex.com/eeo-policy-statement to access our complete Equal Employment Opportunity statement. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. Stay ConnectedFollow us on social media Letter from the CEO Our Values Contact Us

JOB TITLE: (Sr.) Clinical Trial Assistant, Clinical Operations

LOCATION: Seaport, Boston, MA (Hybrid) DATE PREPARED: August 14, 2025

JOB SUMMARY:

Aveo Oncology is looking for an experienced Clinical Operations professional.The Clinical Trial Assistant will report to the Vice President or Associate Director, Clinical Operations. The role is primarily responsible for supporting close interactive oversight to ensure exceptional execution of AVEO Oncology clinical studies. The Clinical Trial Associate will also be accountable for participating in departmental efficiency initiatives in support of department excellence.

The Clinical Trial Assistant will support monitoring clinical studies across geographic regions, in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), regulatory authority guidance and directives such as Food and Drug Administration (FDA), and International Conference on Harmonization (ICH) guidelines.

The Clinical Trial Assistant will support ensuring quality data for all clinical trials. The Clinical Trial Assistant will support the interactions with CROs and other 3rd party vendors to ensure study milestones and deliverables are achieved according to agreed quality standards and timelines so that data is suitable for regulatory submissions and publications. The Clinical Trial Assistant will also support metrics-based assessments to measure departmental and 3rd party performance on a quarterly basis to meet corporate goals. The Clinical Trial Assistant will also assist with troubleshooting routine site inquiries.

Outside interfaces may include other Aveo Oncology business groups and subsidiaries in the US and abroad, governmental, academic, community and industry organizations.

The Clinical Trial Assistant will not have assigned direct reports.

Good written and verbal communication skills and attention to detail are required and are equally important. The ideal candidate for this role is an individual who is excited to take on new challenges in a dynamic environment. To be successful, the candidate is committed to collaboration and a data driven approach to align with the teams brand and culture.

PRINCIPAL DUTIES:

Study Management and Leadership

Collaborate closely with Clinical Team in support of study execution

Support planning and logistics for internal and external meetings and preparation of agendas, meetings, and meeting minutes

Support oversight of site compliance with study protocol

Support and maintain metrics-based tools to assess departmental and 3rd party performance on a quarterly basis to meet corporate goals

Support adherence to internal procedures for study planning, study conduct, close out and reporting

Support all inspection readiness and quality initiatives for assigned studies

Maintains and reviews various study-related tracking systems to determine and report status of clinical trial documents (i.e., distribution, status, retrieval of such documents as protocol, IB, etc.)

Support Clinical Project Manager and Clinical Research Associate for meeting minutes as requested

Support study team in tasks such as presentations, mailings to sites, assembly and distribution of Investigator Site Files, newsletters and handling of study documents, copying and filing, correspondence. The CTA will maintain site contact lists, trackers, etc.

Support the Clinical Project Manager for review of invoices.

Generate mass mailings upon request of the Clinical Project Manager.

Perform administrative tasks to support team members with clinical trial execution as needed.

CRO, 3rd Party Vendor Management and Oversight for assigned studies

Support tracking of operational study timelines and monitor operational performance metrics through the life of the study, support issue resolution

Support Biosample tracking from sites to central lab sample management to central analytical lab.

Assist in the creation and review of informed consents, case report forms, study operations manuals, monitoring tools, and other study-related materials

Support site level progress ensuring timely data collection, source document verification, and query resolution

Develop and maintain audit-ready clinical trial documentation in the TMF: Manage and track regulatory/IRB/EC documentation, IND Safety Letter distribution, Confidentiality Disclosure Agreements, and other clinical trial documents

Contact clinical sites and/or CROs to complete study files and regulatory document collections to ensure TMF documents are filed in TMF in a timely manner

Ensure timely safety reporting at assigned investigative sites

Assist in the process of executing clinical trial and vendor agreements

Assist with study document filing

Knowledge Management/People Management

In support of goals, the Clinical Trial Assistant will:

Assist in updating SOPs

Support GCP and operational systems training

REQUIRED QUALIFICATIONS/EXPERIENCE (BASIC QUALIFICATIONS):

Bachelor's Degree in a Life Sciences

Minimum of 3 years experience in clinical operations methods and processes in industry setting required

At least 2 years oncology monitoring experience preferred

Strong understanding of ICH, GCP, and relevant regulatory requirements

Good communication skills and proficiency with Microsoft Outlook, Excel, Word and PowerPoint

Familiarity with setting up and maintaining trial master files and performing file audits preferred

Proactive and able to work independently

Ability to prioritize and multi-task with attention to detail

Strong organizational skills

About AVEO

AVEO is a commercial-stage, oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer. AVEO currently markets FOTIVDA (tivozanib) in the U.S. for the treatment of adult patients with relapsed or refractory renal cell carcinoma (RCC) following two or more prior systemic therapies. AVEO continues to develop FOTIVDA in immuno-oncology combinations in RCC and other indications, and has several other investigational programs in clinical development. AVEO is committed to creating an environment of diversity, equity and inclusion to diversify representation within the Company.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Lantheus is headquartered in Bedford, Massachusetts with offices in Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio.

Lantheus is an entrepreneurial, agile, growing organization that provides innovative diagnostics, targeted therapeutics, and artificial intelligence (AI) solutions that empower clinicians to find, fight and follow disease. At Lantheus our purpose and values guide our behaviors in all interactions and play a vital role in creating a dynamic environment that contributes to our success. Every employee is crucial to our success; we respect one another and act as one knowing that someone's health is in our hands. We believe in helping people be their best and are seeking to bring together a diverse group of individuals with different viewpoints and skill sets to be a part of a productive and inclusive team.

This position is site-based and requires a presence on-site three days per week in Bedford, MA.

Summary of Role

The Clinical Trial Associate (CTA), Clinical Operations is responsible for supporting the operational aspects of multiple studies across all stages of a trial (planning, start-up, execution, data analysis, reporting and closure). Responsibilities include generation of progress tracking reports, trial specific system set-up and access management, system data entry, meeting arrangement/minute capture, document management, and investigator meeting set-up and coordination. The CTA, as a key member of the study team is expected to provide the needed support to achieve operational deliverables.

Key Responsibilities / Essential Functions

• Participate in team meetings and prepare meeting agendas and minutes.
• Capture meeting action items and track activity status to closure.
• Develop, setup, and maintain study tracking tools for assigned trials to monitor study progress
• Prepare and maintain study progress data as appropriate (e.g., Key Performance Indicators), and prepare study progress reports as necessary
• Track study-related invoices and payments, and other financial information as needed
• Assist in the creation of study materials including study documents, site and patient facing materials, and presentations
• Contribute to the development and/or review of select study plans
• Distribute trial-related materials to sites and/or study team members
• Manage clinical study documents including reviews for completion, accuracy, and expiration
• Coordinate the collection and review of essential documents to authorize initial investigational product shipment and site activation
• Conduct periodic quality assessments of a vendor managed Trial Master File for outsourced studies
• Support the maintenance of the Trial Master File for sponsor-generated documents, and assist in quality assessments as appropriate
• Participate in CRF development and edit check testing
• Participate in user acceptance testing of study systems
• Participate in functional, cross-functional, and organizational initiatives
• Participate in CRO and clinical vendor oversight
• Perform other activities as assigned

Basic Qualifications

• Education: Bachelor's degree in science or related field
• Minimum of 1-2 years experience in clinical research in industry (sponsor or CRO) is required.
• Preferred: CCRP training / certification

Other Requirements

• General knowledge of applicable clinical research principles and requirements, including GCP and ICH guidelines and applicable regulatory regulations
• Advanced knowledge of clinical study processes
• Intermediate understanding of the Trial Master File reference model and the ability to navigate an eTMF (Veeva Clinical Vault experience preferred).
• Highly proficient in MS Office applications
• Well organized and detail oriented with strong written and verbal communication skills
• Effective time management and organizational skills
• Significant attention to detail
• Highly effective interpersonal skills

Core Values

The ideal candidate will embody Lantheus core values:

• Let people be their best
• Respect one another and act as one
• Learn, adapt, and win
• Know someone's health is in our hands
• Own the solution and make it happen

Lantheus is an equal opportunity employer that provides a workplace free from discrimination. All qualified applicants and employees are considered without regard to race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any other characteristic protected by law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Lantheus Talent Acquisition team at

Responsibilities: We are seeking a highly motivated and qualified individual to join our Clinical Department as a Clinical Trial Manager (CTM) and work as part of a team to drive success. Ideal candidates will be self-motivated, independent, committed to the generation of high-quality data within a fast-paced and innovative research team. The CMT will support ongoing RNA-based drug discovery.

Bayside Solutions is seeking a Clinical Trial Associate for our client located in San Jose. This is an opportunity to get in with a women-run company continuing to grow. They are looking to setup interviews this week an have someone begin before Nove Associate, Clinical, Healthcare, Staffing, Clinic

Clinical Trial Associate Medical Devices

The Clinical Trial Associate (CTA) supports the execution of medical device clinical trials in compliance with study protocols, regulatory requirements, and company procedures. Responsibilities include coordinating meetings, managing trial documentation, maintaining the Trial Master File, assisting with site selection and monitoring, and supporting data management and vendor oversight. The CTA ensures regulatory compliance (GCP, ISO) and facilitates smooth trial operations. Requires a bachelors degree in a scientific or healthcare field (or equivalent experience), strong organizational and communication skills, and familiarity with clinical trial management systems.

Key Responsibilities:

• Lead and manage all operational aspects of global clinical trials from study start-up through close-out
• Oversee study timelines, deliverables, and budgets to ensure milestones are met
• Coordinate with cross-functional teams, external vendors, and CROs to ensure high-quality study conduct
• Oversee site activation, clinical monitoring, data integrity, and adherence to protocol
• Conduct study-level risk assessments and ensure inspection readiness
• Manage safety and pharmacovigilance activities in collaboration with internal and external teams
• Lead internal and external study meetings; provide training to relevant stakeholders
• Contribute to the development of study-related documents and clinical study reports
• Perform other duties as needed to support successful trial execution

Qualifications:

• Bachelors degree in life sciences or a related (advanced degree preferred)
• Minimum of 8 years of clinical trial management experience, particularly in Phase 2/3 respiratory trials
• Demonstrated success in leading global trials and working with cross-functional and vendor teams
• Deep understanding of GCP, ICH guidelines, and global regulatory requirements
• Specific therapeutic experience in respiratory diseases, especially COPD , strongly preferred
• Strong project management, problem-solving, and communication skills
• Proficiency in using clinical trial systems (e.g., eTMF, EDC), Microsoft Office, and Excel

Join to apply for the Clinical Trial Associate role at Actalent

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Join a professional, customer-focused pharmaceutical company as a Clinical Trials Project Coordinator. This role involves supporting the maintenance of study records and coordinating study activities. You will develop, maintain, and archive files and records related to multiple clinical trials while providing administrative support. This position offers a competitive salary and a full benefits package.

Responsibilities

• Work with the Project Management team to assist in planning investigator meetings.
• Develop required materials, including training tools.
• Initiate contract/budget requests, track status, and negotiate budgets with sites and vendors if necessary.
• Participate in vendor selection and management.
• Identify changes in the scope of work.
• Formulate, track, measure, and maintain a project-specific matrix and timelines.
• Schedule and manage agenda updates and meeting minutes for project team meetings.
• Develop monthly reports, newsletters, and communication trackers.
• Provide administrative support such as mass site communication distribution, shipping, filing, tracking, and summarization.
• Assist in the clinical trial insurance process by tracking approvals, revisions, and renewals of certificates.
• Maintain and track all project-specific invoices.
• Ensure a smooth site start-up process prior to Site Initiation Visits.
• Assist the Clinical Operations team with maintaining the trial master file, study site records, and files.
• Review essential study documents.
• Develop project-specific procedural documents as needed.
• Prepare and ship IRB/EC dossiers.
• Assist the study team with training and access management for CTMS and other trial-related applications.
• Prepare for study-specific audits and inspections.
• Perform other duties as assigned by senior management.
  
  

• Proficient in Microsoft Office (Word, Excel, PowerPoint).
• Well-organized with strong attention to detail.
• Excellent verbal and written communication skills.
• Fluent in English; other languages are a plus.
• Ability to work independently and with flexibility to accommodate international meeting schedules.
• Strong interpersonal skills.
  
  

• Minimum of an associates degree; bachelors degree preferred.
• Previous experience in a healthcare company.
• Experience with trial master file maintenance, auditing, and reconciliation preferred.
• Experience with archival of paper files and auditing archived files.
• Meeting agenda and minute-taking experience.
• Experience interacting with Contract Research Organizations and third-party vendors.
• Experience with Electronic Trial Master File systems.
• Experience in clinical trial management systems.
  
  

• Seniority level Entry level

• Employment type Full-time

• Job function Research, Analyst, and Information Technology
• Industries Business Consulting and Services

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**Job Type: Full Time. Base Hours: 9:30AM - 6:30PM Monday through Friday**

**Minimum Qualification Requirements**

To perform this job, an individual must be able to perform each essential duty satisfactorily, and meet the educational and experience requirements.

**Essential Duties And Responsibilities*

• Review database for panelists with matching inclusion/exclusion criteria to upcoming clinical trial protocols.
• Contact potential subjects and discuss clinical trial requirements and availability to participate.
• Ensure compliance with protocols, and standard operating procedures.
• Data entry of subject data into database.
• Provide assistance to clinical and photobiology departments as needed.

**Education and/or Experience*

High School diploma / GED required

General Office Equipment Skills

2 years clerical experience preferred

**Communication Skills*

Evidence of a strong communication and interpersonal skills with the ability to facilitate multi-disciplinary teams.

**Other Knowledge, Skills and Abilities*

Computer skills: MS Word and Excel required

Organizational, analytic, and problem-solving skills

Attention to detail; ability to maintain confidentiality

Strong customer service skills necessary

Applicant should possess the ability to organize and maintain all data for assigned projects and ensure adherence to established policies and procedures.

**Physical Requirements*

On an average 8-hour day this position requires the ability to walk, sit and stand, use hands to handle or feel, reach with hands and arms at or above shoulder height and below waist height, climb or balance, stoop, kneel, crouch; talk, hear, and smell. Specific vision requirements including reading of written documents, visual inspection of documents and use of computer monitor screen frequently. This position entails repetitive motion with keyboard and mouse. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age or any other characteristic protected by law.