Clinical Trial Associate (Hybrid)
hace 23 horas
Houston
Job Description Job Title: Clinical Trial Associate (Hybrid) Position is Hybrid Onsite 1-2 days a week Job Description The Clinical Trial Associate plays a key role in the successful execution of global clinical investigations by supporting the logistics and operational aspects of clinical studies. Working as part of the global Clinical Affairs and Clinical Operations teams, this role collaborates closely with Clinical Operations Managers, Clinical Project Managers, and other study staff to ensure that studies run efficiently, documentation remains inspection-ready, and timelines are met. The Clinical Trial Associate works with a high degree of autonomy, proactively drives processes forward, and serves as a reliable operational partner to the broader study team. Responsibilities • Set up electronic Trial Master Files (eTMF) and maintain in-house filing of Trial Master File documents in accordance with standard operating procedures and good clinical practice guidelines (including ISO standards)., • Support ongoing use of clinical trial management systems (CTMS) by maintaining and tracking study contacts and relevant activities., • Support study start-up and site selection processes, including preparation and follow-up of confidentiality agreements, retrieval of completed site selection questionnaires, and maintenance of site selection trackers., • Coordinate translations of study documents to support global clinical investigations., • Assist in preparing submission packages for Ethics Committees, Institutional Review Boards (IRBs), and Competent Authorities, including pulling outcome documents from IRB systems where applicable., • Prepare documentation for Site Initiation Visits by creating site-specific documents and compiling Investigator Site Files, or overseeing external suppliers responsible for these materials., • Under general supervision, ensure timely filing and tracking of study essential documents and maintain the quality and completeness of the Trial Master File to ensure audit and inspection readiness at all times., • Perform quality control checks of uploaded data and documentation in relevant systems., • Assist in the preparation for and provide support during audits and inspections related to clinical studies., • Manage logistics for study-related supplies and services (excluding non-investigational devices), including coordination of study material shipments to clinical study sites., • Support the study team in general conduct activities, such as organizing meetings, preparing newsletters and presentations, coordinating mailings to sites, and managing general correspondence., • Review and update dashboards and tracking tools to provide accurate visibility into study status and key activities., • Maintain site and sponsor contact information in CTMS for each study, including start and stop dates, and send regular updates to sites as needed., • Maintain study-specific training matrices to track required and completed training for study personnel., • Track study insurance coverage and maintain associated documentation., • Track study agreements and contracts to ensure timely execution and ongoing compliance., • Support the set-up of dedicated payment systems (within CTMS or external tools) for study-related payments., • Prepare, track, and process study site invoices, maintain payment overviews, and support accruals, tracking, and maintenance of purchase orders., • Support quarterly HCO/HCP Sunshine Reporting for applicable US-based activities., • Participate in internal project meetings, taking notes and documenting action items to ensure follow-up and accountability., • Support and follow up on local team meetings and local investigator meetings, including managing attendee lists, agendas, meeting materials, and meeting minutes where applicable., • Support study and site close-out activities, including invoice reconciliation and coordination of device and supply returns., • Support the team with system uploads and follow-up activities related to engagement and contract management tools., • Support Study Start-Up (SSU) activities, including essential document collection, review, and coordination of site activation steps., • Manage site agreements and site selection activities in close collaboration with clinical project management., • Coordinate IRB submissions and track approvals to ensure sites remain compliant and authorized to conduct study activities., • Prepare documentation for Site Initiation Visits (SIVs) and Site Monitoring Visits (SMVs), ensuring all materials are accurate and complete., • Oversee documentation uploaded into the Trial Master File, ensuring accuracy, completeness, and alignment with regulatory expectations., • Support oversight of clinical supply shipments, including coordination of label setup performed internally and collaboration with teams responsible for shipping logistics., • Support FDA-related filings and systems as needed for clinical studies., • Actively learn and own operational processes, drive work forward independently, and serve as a solution-oriented partner who reduces workload for the broader team rather than creating additional work. Essential Skills • Minimum of 4+ years of prior work experience as a Clinical Research Associate or in a comparable position supporting or assisting clinical project management within a medical device company, pharmaceutical company, or contract research organization., • Clinical research experience, including hands-on involvement in clinical trials or clinical investigations., • Experience supporting study start-up and site management activities., • Familiarity with FDA filing systems and regulatory documentation., • Knowledge of international regulations and guidelines such as ISO 14155 and Good Clinical Practice (GCP), as well as clinical study design and implementation., • Strong organizational and document management skills with proven ability to maintain inspection-ready files., • Working knowledge of medical terminology relevant to clinical research., • Ability and willingness to learn device function and understand how it relates to clinical use., • Capability to interface effectively and professionally with medical professionals and site staff., • Strong analytical and organizational skills with excellent attention to detail and accuracy., • Demonstrated project oversight and tracking capability, including use of trackers and dashboards., • Good oral and written communication skills, especially in email and virtual collaboration tools., • Ability to work autonomously with excellent organizational skills and the ability to prioritize assignments while handling multiple projects simultaneously., • Experience with electronic data capture systems and clinical trial management systems (CTMS)., • Demonstrated ability to perform effectively in a team environment and build strong working relationships., • Fluency in English, both written and spoken., • Ability to travel to clinical centers as needed, with a willingness to travel at least 25%., • Associates degree (AS) or Bachelors degree (BS). Additional Skills & Qualifications • Experience as a Clinical Research Coordinator (CRC), particularly in hospital-based research or within care facilities, clinics, or healthcare systems., • Experience in project management or project coordination roles, especially in clinical or research settings., • Previous experience in administrative support, project coordination, contract support, procurement, or business operations., • Experience with electronic data capture platforms and familiarity with engagement or contract management systems., • Familiarity with Sunshine Reporting requirements for healthcare organizations and professionals., • Ability to create and maintain tracking systems, such as spreadsheets, to monitor status, next steps, and outstanding approvals., • Strong follow-up skills and comfort with professionally and persistently pursuing approvals and information., • Proactive, self-directed work style with the ability to learn processes quickly and take ownership of tasks with minimal direction., • Good problem-solving and critical-thinking skills, with the ability to figure out next steps without extensive guidance., • Understanding of organizational dynamics and appropriate escalation paths, including knowing whom to contact and when to escalate issues., • Mature and professional demeanor with strong relationship-building skills., • Strong communication skills via email and virtual collaboration tools such as Microsoft Teams., • Comfort with learning new systems independently and adapting to new technologies., • Experience in pharma or biotech environments or familiarity with the industry is beneficial but not mandatory for a quick learner., • Experience with project oversight, tracking tools, dashboards, and reporting., • Additional language skills beyond English are advantageous. Work Environment This role operates in a hybrid work environment, with on-site presence required approximately one to two days per week and the remainder of the time worked remotely. The position is embedded within a global Clinical Affairs and Clinical Operations organization that collaborates across functions, regions, and clinical sites. The work involves extensive use of digital tools and systems, including electronic Trial Master File (eTMF) platforms, clinical trial management systems (CTMS), electronic data capture systems, IRB and regulatory portals, and standard office productivity and collaboration tools such as email and Microsoft Teams. The environment emphasizes professionalism, collaboration, and proactive ownership of processes, with a strong focus on maintaining audit-ready documentation and meeting regulatory standards. Travel to clinical centers is required as needed, with an expected travel commitment of at least 25%, which may include visits to hospitals, clinics, or other research facilities. The role supports a culture of teamwork, continuous learning, and mutual support, where individuals are encouraged to take initiative, manage their workload independently, and contribute to the smooth execution of global clinical studies. Job Type & Location This is a Contract position based out of Houston, TX. Pay and Benefits The pay range for this position is $45.00 - $45.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave) Job Type & Location This is a Contract position based out of Houston, TX. Application Deadline This position is anticipated to close on Nov 2, 2026. Workplace Type This is a hybrid position in Houston,TX. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service. The company is an equal opportunity employer and will consider all applications withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law. If you would like to request a reasonable accommodation, such as the modification oradjustment of the job application process or interviewing process due to a disability,please email actalentaccommodation@actalentservices.com for other accommodation options. San Francisco Fair Chance Ordinance:Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in thecity and county of San Francisco, we will consider for employment qualified applicantswith arrest and conviction records. Massachusetts Lie Detector:It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall be subject to criminal penalties and civil liability. Use of Artificial Intelligence (AI):We may use Artificial Intelligence (AI) to support parts of our hiring process,including sourcing, screening, and evaluating candidates. AI helps assess applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.
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