8,849 Clinical Trial jobs in the United States

• Ensure all tasks comply with Good Clinical Practice (GCP) and regulatory guidelines
• Maintain effective collaboration with internal and external stakeholders
• Structure, manage, Quality Control (QC) review and provide detailed oversight of Merus's clinical trial document filing system (eTMF and/or physical) including follow-up on metrics and remediation of any noted deficiencies from internal and external review processes
• File and (QC) essential clinical trial documents for assigned trials
• Instruct and support CTAs on QC and filing procedures (Sr. CTA responsibility)
• Maintain and monitor access to Microsoft TEAMS channels, share point sites, and any relevant clinical systems, trackers, training tools etc. for both internal and external members; regularly review access permissions and content
• Coordinate and schedule meetings including room reservations and dial-in/virtual access details, as well as provide detailed minutes and finalized agendas for multiple meetings
• Lead onboarding for Clinical Operations project staff, including system access requests and GCP and study training setup
• Initiate monthly project compliance dashboard updates for assigned studies and work to finalize updates with oversight from the Clinical Trial Manager (CTM) and / or Project Director (PD)
• Initiate requests and track project Confidentiality Disclosure Agreements (CDAs), Clinical Trial Agreements (CTAs) and Purchase Orders (PO) for assigned project
• Maintain Clinical Trial Trip Report Review Tracker in collaboration with the CTM assigned to review reports. Initiate follow-up with Clinical Research Organization (CRO) on remediation of findings.
• Completion of ClinicalTrials.Gov postings as necessary according to processes, with detailed oversight from CTM / Project Director assigned
• Maintenance of an actions decisions log (ADI log) for assigned project covering all internal meetings and provision of follow-up of remediations with CTM oversight

• Support in locating and providing scientific, clinical, or regulatory literature
• Respond to documentation requests and assist with document archiving for audits, inspections, and internal reviews

• Assist in generating standard outputs and reports and documenting necessary follow-up from electronic Case Report Forms (eCRFs)
• Support documentation and tracking of ongoing data reviews
• Follow up with CROs for monthly protocol deviation (PD) listings and ensure monthly meetings of PD review with leadership and oversight from the CTM

• Track and manage Confidentiality Agreements (CDAs) and Clinical Trial Agreements (CTAs) in Veeva Vault
• Maintain and update trackers; coordinate follow-ups with CROs and internal stakeholders
• Review, track, and file vendor invoices; support invoice-related communication and management

• Process internal sign-off cascades for the IMP Release Checklist (GLP Checklist) and maintain filing status trackers
• Track and follow up with CROs regarding temperature monitoring logs and documentation for drug shipments to clinical sites

• Assist in procuring clinical trial-related resources (books, articles, training)
• Support creation and maintenance of Purchase Orders (POs) in SAP
• Ensure accurate filing and tracking of vendor invoices

• Support preparation of newsletters and updates for clinical trial sites
• Create summaries and reports to support trial site engagement and performance tracking

• Participate in global clinical project and trial team meetings; prepare meeting minutes when requested
• Attend internal Clinical Operations meetings and record meeting minutes as needed

• Assist in drafting, reviewing, and updating Standard Operating Procedures (SOPs)
• Submit and track access requests for shared file systems (e.g., SharePoint) on behalf of the Clinical and Translational Science teams

• Bachelor's degree in Biomedical Sciences, Life Sciences, or a related field
• Strong proficiency in Microsoft Office Suite (Word, Outlook, Excel, PowerPoint)
• Working knowledge of GCP, ICH guidelines, and clinical documentation requirements
• Familiarity with clinical systems including Veeva Vault, eTMF, SAP, and SharePoint is a plus
• Strong attention to detail with excellent organizational skills and the ability to manage multiple priorities
• Clear and professional written and verbal communication skills

Generate:Biomedicines is a new kind of therapeutics company existing at the intersection of machine learning, biological engineering, and medicine pioneering Generative Biology to create breakthrough medicines where novel therapeutics are computationally generated, instead of being discovered. The Company has built a machine learning-powered biomedicines platform with the potential to generate new drugs across a wide range of biologic modalities. This platform represents a potentially fundamental shift in what is possible in the field of biotherapeutic development.

We pursue this audacious vision because we believe in the unique and revolutionary power of generative biology to radically transform the lives of billions, with an outsized opportunity for patients in need. We are seeking collaborative, relentless problem solvers that share our passion for impact to join us!

Generate:Biomedicines was founded in 2018 by Flagship Pioneering and has received nearly $700 million in funding, providing the resources to rapidly scale the organization. The Company has offices in Somerville and Andover, Massachusetts with 300+ employees.

The Role:

Generate:Biomedicines is seeking a detail-oriented and highly collaborative Clinical Trial Associate to support Phase 3 clinical trials within our Clinical Development team. Reporting to the Sr. Director of Late Stage Clinical Operations, this role will play a critical part in enabling high-quality execution of pivotal trials designed to support regulatory submissions and eventual product approval. The CTA will work cross-functionally with Clinical Supply, Data Management, Regulatory, QA, and CROs to maintain inspection-readiness, ensure compliance with GCP standards, and support key trial deliverables.

This is an exciting opportunity for someone who thrives in high-accountability environments and is eager to contribute to the final stages of clinical development with rigor and excellence.

Here's how you will contribute:

• Support execution of Phase 3 clinical trials, including global site activation, study conduct, and closeout activities.
• Manage Trial Master File (TMF) setup, maintenance, and QC to ensure real-time, inspection-ready documentation.
• Collaborate with CROs to review monitoring visit reports, protocol deviations, and key performance indicators (KPIs).
• Coordinate with internal teams and vendors to ensure trial activities align with the stringent regulatory requirements of Phase 3 trials.
• Assist in the collection and review of essential regulatory documentation required for trial initiation and maintenance.
• Organize study meetings, manage action and decision logs, and ensure high-quality documentation of operational progress.
• Track progress against timelines, escalate risks or delays, and contribute to mitigation planning.
• Support clinical audit readiness efforts, including document review, reconciliation, and regulatory filing preparation.
• Maintain informed consent and protocol amendment tracking across global trial sites.
• Assist in clinical vendor invoice reconciliation and budget tracking.

The Ideal Candidate will have :

• Bachelors degree; life sciences or related degree preferred
• 2+ years of experience supporting Phase 3 clinical trials at a sponsor or CRO.
• Proficient in clinical systems (eTMF, CTMS) and knowledgeable of FDA and ICH-GCP requirements for pivotal studies.
• Demonstrates strong organizational skills, problem solving, and effective communication
• Demonstrates understanding of the clinical drug development process, including study design, protocol objectives and operational impacts
• Ideal candidates will have understanding site management and monitoring practices, including importance of data quality/integrity, as well as fundamental understanding of protocol deviation identification and reporting
• Must be proficient in MS Office applications (word, excel, and PowerPoint at a minimum) to support study/program documentation and deliverables
• Basic understanding and importance of current ICH-GCP regulations/guidelines is required
• Enthusiastic, proactive, collaborative, and dependable
• Excited to learn and grow within the clinical operations team!
• Organized (with attention to detail) and able to problem solve
• Comfortable in a fast-paced environment and able to manage and prioritize competing tasks
• Travel is required as needed, however minimal (no more than 10-20% for monitoring related work)

Generate:Biomedicines is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.

Recruitment & Staffing Agencies : Generate:Biomedicines does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Generate:Biomedicines or its employees is strictly prohibited unless contacted directly by the Companys internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Generate:Biomedicines and the Company will not owe any referral or other fees with respect thereto.

Compensation: The base salary range provided reflects our current estimate of what we anticipate paying for this position. Your actual base salary will be based on several factors, including job-related skills, experience, internal equity, relevant education or training, and market dynamics. In addition, you will be eligible for an annual bonus, equity compensation, and a competitive benefits package.

Per Year Salary Range

$9,000 103,000 USD

• Seniority level Entry level

• Employment type Full-time

• Job function Research and Analyst
• Industries Biotechnology Research and Pharmaceutical Manufacturing

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Medical insurance

Vision insurance

401(k)

Paid maternity leave

Paid paternity leave

Tuition assistance

Disability insurance

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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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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

The Clinical Trial Associate (CTA) provides administrative support to the Clinical Operations Department. The primary purpose of the position is to facilitate efficient clinical trial planning and execution. Responsibilities Set up and maintain clini Clinical, Associate, Operations, Healthcare

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 Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor. #J-18808-Ljbffr

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

Job Description

Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing.

Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.

Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.

The Position

The Clinical Trial Associate (CTA) provides administrative support to the Clinical Operations Department. The primary purpose of the position is to facilitate efficient clinical trial planning and execution.

Responsibilities

• Set up and maintain clinical trial master files (hardcopy and/or electronic format) in compliance with SOPs
• Develop and maintain study tools including trackers, spreadsheets, and filing systems for various studies
• Preparation and revision of Purchase orders; follow-up with vendors on invoice issues
• Plan and coordinate department meetings and activities, as requested, including handling logistics, preparation of agendas, distribution of meeting materials
• Assist COMs with drug and ancillary supply management
• Assist with preparation of study related documents and presentations
• Assist Associate Director with Clin Ops SOP/WI team training
• Assist COMs with eTMF filing and reconciliation as needed
• Attend department meetings and record minutes as requested
• Facilitate initiation of and track study agreements and contracts for COMs
• QC study related documents (Protocols, ICFs, Study Plans, etc.)
• May function as a liaison between clinical vendors on behalf of COMs
• Manage off-site document storage and recall as applicable
• Any other study related tasks assigned by Clinical Operations Team members

Requirements:

• At least 2 years' experience in similar industry position
• Pharmaceutical or biotechnology environment experience and familiarity with basic GXP highly valued but not mandatory
• Proficiency with computer programs including Microsoft Office Suite

Preferred:

• 4-year college degree preferred

California pay range

$60,000—$80,000 USD

Arrowhead provides competitive salaries and an excellent benefit package.

All applicants must have authorization to work in the US for a company.

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