Clinical Research Associate

3 days ago

Aurora, Colorado, United States CPC Clinical Research Full time
Job Summary

We are seeking a highly organized and detail-oriented individual to join our team as a Trial Master File Associate. In this role, you will be responsible for contributing to the development and management of both paper and electronic Trial Master File (TMF) systems for clinical trials.

Key Responsibilities
  • Develop and manage TMF systems to ensure completeness, accuracy, and compliance with local, federal, and international regulations, guidelines, and company policies.
  • Upload study documents into various eTMF platforms and reconcile and conduct quality control (QC) for eTMF uploads.
  • Ensure timely and accurate filing of essential documents in accordance with regulatory requirements and company SOPs.
  • Collaborate with Study Teams to ensure effective implementation of TMF Management Plans.
  • Assist in the creation, maintenance, and tracking of Trial Master Files for each assigned study.
  • Reconcile and participate in the Quality Control of documents (paper and electronic) submitted to the TMF.
  • Perform regular reviews and quality checks of the TMF to ensure completeness, accuracy, timeliness, and consistency.
  • Support the transfer of study-specific TMF to designated parties.
  • Manage close-out of TMF-related issues and act as a point of contact for Study Team TMF questions in collaboration with the TMF specialist.
  • Collaborate with team members to address any discrepancies or missing documents.
  • Work closely with cross-functional teams to ensure timely submission and retrieval of essential documents.
  • Aid in the identification and resolution of documentation issues.
  • Educate and support Study Teams and content owners on TMF-related responsibilities.
  • Identify opportunities for process improvements for TMF management, including the development and update of SOPs and WIs and training materials, as necessary.
  • Collaborate with team members to implement QC initiatives for TMF activities, ensuring continuous improvement in overall processes.
  • Prepare and support TMF-related audits and inspections by regulatory authorities, ensuring all necessary documentation is readily available and compliant.
Requirements
  • Bachelor's degree preferred or equivalent knowledge/experience gained through a minimum of 1 year in a clinical research setting.
  • Familiarity with applicable regulatory requirements (e.g., ICH, GCP, and FDA) for conducting clinical trials.
  • Working knowledge of the DIA Trial Master File Reference Model and a demonstrated understanding of Clinical Trial records management best practices.
  • Knowledge of clinical documents maintained in the eTMF.
  • Previous experience in electronic Trial Master File systems and document management is preferred.
  • Proficient in MS Office applications (e.g., Word, Excel, and Outlook).
  • Excellent organizational and communication skills (both verbal and written).
  • Strong problem-solving skills and detail-oriented, capable of managing multiple tasks with effective prioritization.
  • A collaborative team player, capable of interacting positively and educationally with individuals possessing varied skill sets.
About CPC Clinical Research

CPC Clinical Research is an academic research organization that offers full-service clinical trial design, oversight, and management with rapid access to Key Opinion Leaders in a variety of therapeutic areas. With over 30 years of experience, CPC has provided services to over 150 clinical trials in a variety of indications, with an emphasis on cardiovascular, wound healing, diabetes, and more.

CPC has expertise in managing clinical trials from a variety of funding sources, including Industry, NIH, and Investigator-Initiated trials.

CPC Community Health focuses on innovative programs that reach into communities to help people find effective ways to become active, empowered, and healthy.

CPC offers a comprehensive benefits package, including medical, dental, vision, life, STD, LTD, and a matching 401(k) plan. We also offer 11 paid holidays, vacation days based on years of service, paid sick time, an in-suite exercise and relaxation room, and flexible and remote work schedules.

CPC is an Equal Opportunity Employer and provides equal employment opportunities to all employees and applicants for employment without regard to race, sex, color, ancestry, sexual orientation, gender identity, gender expression, marital status, religion, creed, national origin, disability, military status, genetic information, age 40 and over, or any other status protected by applicable federal, state, or local law.

  • Clinical Research Associate II

    3 weeks ago

    Aurora, Colorado, United States CPC Clinical Research Full time

    Job SummaryWe are seeking a highly skilled Clinical Research Associate II to join our team at CPC Clinical Research. As a key member of our clinical trials team, you will be responsible for ensuring the smooth execution of clinical trials, from site initiation to close-out.Key ResponsibilitiesSite Monitoring: Conduct regular site visits to ensure compliance...

  • Clinical Research Assistant

    1 week ago

    Aurora, Colorado, United States CPC Clinical Research Full time

    Job Opportunity: Clinical Research InternCPC Clinical Research is seeking a highly motivated and detail-oriented Clinical Research Intern to join our team. As a Clinical Research Intern, you will have the opportunity to gain hands-on experience in clinical research management, working closely with our experienced team of researchers and clinicians.Key...

  • Senior Clinical Trial Manager

    3 weeks ago

    Aurora, Colorado, United States CPC Clinical Research Full time

    Job DescriptionJob Summary:CPC Clinical Research is seeking an experienced Senior Clinical Trial Manager to lead and manage clinical trials site operations. The ideal candidate will have a strong background in clinical research, excellent communication and organizational skills, and the ability to work independently with minimal supervision.Key...

  • Senior Clinical Trial Manager

    3 weeks ago

    Aurora, Colorado, United States CPC Clinical Research Full time

    Job DescriptionJob Summary:CPC Clinical Research is seeking an experienced Senior Clinical Trial Manager to lead and manage clinical trials site operations. The ideal candidate will have a strong background in clinical research, excellent communication and organizational skills, and the ability to work independently with minimal supervision.Key...

  • Clinical Operations Manager II

    3 weeks ago

    Aurora, Colorado, United States CPC Clinical Research Full time

    Job DescriptionJob Summary:CPC Clinical Research is seeking an experienced Clinical Operations Manager II to oversee clinical operations management activities, define and monitor project scope, timelines, and deliverables, and provide expert advice in the design, writing, and/or review of all project-related essential documents.Key Responsibilities:Project...

  • Clinical Trial Manager

    4 days ago

    Aurora, Colorado, United States CPC Clinical Research Full time

    Job SummaryCPC Clinical Research is seeking a highly experienced Clinical Trial Manager to lead and manage clinical trials from start to finish. As a key member of our team, you will be responsible for ensuring the successful execution of clinical trials, from site initiation to close-out.Key ResponsibilitiesDevelop and implement clinical trial strategies to...

  • Research Assistant I

    3 hours ago

    Aurora, Colorado, United States CPC Clinical Research Full time

    Job SummaryWe are seeking a highly organized and detail-oriented Research Assistant I to support our clinical research team.Key ResponsibilitiesProvide administrative support for clinical trials, including data management, document preparation, and communication with investigational sites.Assist in the preparation of study materials, including protocols,...

  • Research Assistant I

    1 week ago

    Aurora, Colorado, United States CPC Clinical Research Full time

    Job SummaryWe are seeking a highly organized and detail-oriented Research Assistant I to support our clinical research team.Key ResponsibilitiesProvide administrative support for clinical trials, including data management, document preparation, and communication with investigational sites.Assist in the preparation of study materials, including protocols,...

  • Research Assistant II

    1 week ago

    Aurora, Colorado, United States CPC Clinical Research Full time

    Job SummaryWe are seeking a highly organized and detail-oriented Research Assistant II to support our clinical research team. The successful candidate will have a strong understanding of Good Clinical Practice guidelines and applicable regulations, as well as excellent communication and organizational skills.Key ResponsibilitiesProvide administrative support...

  • Clinical Operations Manager

    7 days ago

    Aurora, Colorado, United States CPC Clinical Research Full time

    Job SummaryWe are seeking an experienced Clinical Operations Manager to join our team at CPC Clinical Research. The successful candidate will be responsible for managing clinical trials from initiation to close-out, ensuring compliance with regulatory requirements and company policies.Key ResponsibilitiesManage site identification, evaluation, initiation,...

  • Clinical Trial Master File Specialist

    4 weeks ago

    Aurora, Colorado, United States CPC Clinical Research Full time

    Position Overview We are looking for a dedicated Trial Master File Associate to become a vital part of our organization.Key Responsibilities:Assist in the creation and oversight of Trial Master File systems for clinical studiesManage the uploading of study documentation into electronic TMF platformsGuarantee the prompt and precise organization of essential...

  • TMF Management Associate

    1 month ago

    Aurora, Colorado, United States CPC Clinical Research Full time

    Job Overview We are looking for a dedicated Trial Master File Associate to become a vital part of our organization.Key Responsibilities:Assist in the creation and oversight of Trial Master File systems for clinical studiesUpload essential study documentation into electronic TMF platformsGuarantee the prompt and precise organization of critical documentsWork...

  • Clinical Operations Manager II

    7 days ago

    Aurora, Colorado, United States CPC Clinical Research Full time

    Job SummaryCPC Clinical Research is seeking an experienced Clinical Operations Manager II to oversee clinical operations management activities, define and monitor project scope, timelines, and deliverables, and provide expert advice in the design, writing, and review of project-related essential documents.Key ResponsibilitiesOversee clinical operations...

  • Senior Clinical Operations Manager

    4 days ago

    Aurora, Colorado, United States CPC Clinical Research Full time

    Job Title: Senior Clinical Operations ManagerWe are seeking a highly experienced Senior Clinical Operations Manager to join our team at CPC Clinical Research. As a key member of our clinical operations team, you will be responsible for managing clinical trials from initiation to close-out, ensuring compliance with regulatory requirements and company...

  • Clinical Trial Supply Chain Specialist

    4 weeks ago

    Aurora, Colorado, United States CPC Clinical Research Full time

    Job OverviewCPC Clinical Research is looking for a dedicated professional to fill the role of Clinical Trial Drug Supply Specialist.The Clinical Trial Drug Supply Specialist will oversee regulatory and investigational product management to facilitate our clinical studies. This role involves supervising both internal protocols and external partners, including...

  • Clinical Trial Supply Chain Specialist

    1 month ago

    Aurora, Colorado, United States CPC Clinical Research Full time

    Job OverviewCPC Clinical Research is looking for a dedicated professional to fill the role of Clinical Trial Drug Supply Specialist.The Clinical Trial Drug Supply Specialist will oversee the management of regulatory and investigational product activities essential for our clinical studies. This role involves supervising both internal processes and external...

  • Clinical Trial Supply Chain Manager

    1 month ago

    Aurora, Colorado, United States CPC Clinical Research Full time

    Job OverviewCPC Clinical Research is looking for a dedicated professional to fill the role of Clinical Trial Drug Supply Specialist.The Clinical Trial Drug Supply Specialist will play a crucial role in overseeing regulatory and investigational product functions essential for our clinical studies. This position entails managing both internal workflows and...

  • Clinical Trial Manager I

    3 weeks ago

    Aurora, Colorado, United States CPC Clinical Research Full time

    Job DescriptionJob Summary:CPC Clinical Research is seeking a highly skilled Clinical Trial Manager I to serve as the primary point of contact for clinical trials site operations. As a key member of our team, you will be responsible for ensuring the smooth execution of clinical trials at our partner sites.Key Responsibilities:Site Operations Management:...

  • Clinical Operations Manager I

    6 days ago

    Aurora, Colorado, United States CPC Clinical Research Full time

    Job Title: Clinical Operations Manager IWe are seeking a highly skilled Clinical Operations Manager I to join our team at CPC Clinical Research. This role is ideal for an individual who can motivate teams to do great work collaboratively in order to produce the best quality outcomes possible.Key Responsibilities:Manage site identification and evaluation to...

  • Clinical Research Associate

    5 days ago

    Aurora, Colorado, United States University of Colorado Full time

    Clinical Research Coordinator Job SummaryWe are seeking a highly motivated and detail-oriented Clinical Research Coordinator to join our team at the University of Colorado Anschutz Medical Campus. As a Clinical Research Coordinator, you will play a critical role in the day-to-day operations of clinical trials and studies, ensuring the smooth execution of...