Current jobs related to Clinical Trial Document Specialist - Raleigh, North Carolina - AA2IT

  • Clinical Trial Operations Specialist

    3 weeks ago

    Raleigh, North Carolina, United States Advanced Recruiting Partners Full time

    **Clinical Trial Operations Specialist**At Advanced Recruiting Partners, we are seeking a highly skilled Clinical Trial Operations Specialist to join our team. As a key member of our clinical operations team, you will be responsible for ensuring the smooth execution of clinical trials.Main Responsibilities:Develop TMF Plans and conduct ongoing and final QC...

  • Clinical Trial Educator

    1 month ago

    Raleigh, North Carolina, United States IQVIA Full time

    At IQVIA, we are seeking a Clinical Trial Educator to join our team. As a Clinical Trial Educator, you will provide information and education on clinical trial inclusion and exclusion criteria to trial coordinators and healthcare providers. You will also provide in-service presentations to increase patient enrollment and work in partnership with CRAs and...

  • Clinical Trial Associate II

    4 weeks ago

    Raleigh, North Carolina, United States Allen Spolden Full time

    Job Title: Clinical Trial Associate IIJob Summary:We are seeking a highly motivated and detail-oriented Clinical Trial Associate II to join our team at Allen Spolden. As a Clinical Trial Associate II, you will play a critical role in supporting the operational strategy and execution of clinical studies.Key Responsibilities:* Provide support for essential...

  • Product Owner Clinical Trial Enablement Specialist

    4 weeks ago

    Raleigh, North Carolina, United States LabCorp Full time

    Job DescriptionThe Product Owner will support the Real World Data Product Strategy team in developing clinical trial enablement products that leverage Labcorp's vast clinical and diagnostic data to optimize clinical trial design and recruitment.Key ResponsibilitiesServes as a liaison between business stakeholders and the technical team, facilitating...

  • Senior Director of Decentralized Clinical Trials

    4 weeks ago

    Raleigh, North Carolina, United States IQVIA Full time

    Job OverviewIQVIA is seeking an experienced and dynamic Senior Director to drive the growth of our Decentralized Clinical Trials solutions. This includes creating a sales strategy, advocating for the use of DCT in the industry, interacting with executives at sponsors, and representing IQVIA at industry conferences.The ideal candidate will have a proven track...

  • Senior Director of Decentralized Clinical Trials

    4 weeks ago

    Raleigh, North Carolina, United States 5PY US Quintiles, Inc. Full time

    Job OverviewIQVIA is seeking an experienced and dynamic Senior Director to drive the growth of our Decentralized Clinical Trials solutions. This includes creating a sales strategy, advocating for the use of DCT in the industry, interacting with executives at sponsors around the value of DCT and hybrid DCT trials, and representing IQVIA at industry...

  • Clinical Project Manager

    1 month ago

    Raleigh, North Carolina, United States Advanced Recruiting Partners Full time

    Advanced Recruiting Partners is seeking a seasoned Clinical Project Manager to lead global clinical trials in the respiratory space. The ideal candidate will have a strong background in clinical research and experience managing projects from start-up to close-out.Key Responsibilities:Lead global clinical trials from start-up to close-outOversee and manage...

  • Senior Director of Decentralized Clinical Trials Strategy

    2 days ago

    Raleigh, North Carolina, United States IQVIA Full time

    Job OverviewIQVIA is seeking an experienced Senior Director to drive the growth of our Decentralized Clinical Trials solutions. This includes creating sales strategies, advocating for the use of DCT in the industry, and representing IQVIA at industry conferences to promote our solutions.Key ResponsibilitiesLead sales pursuits for opportunities that include...

  • Senior Clinical Project Manager

    1 month ago

    Raleigh, North Carolina, United States Catalyst Clinical Research LLC Full time

    Job OverviewCatalyst Clinical Research LLC is seeking a highly skilled Senior Clinical Project Manager - Oncology to lead the coordination and management of clinical trials from start-up through close-out activities.Key Responsibilities:Develop and implement project plans, monitoring plans, and regulatory plans.Facilitate team training and direct project...

  • Senior Clinical Research Associate

    4 weeks ago

    Raleigh, North Carolina, United States Catalyst Clinical Research LLC Full time

    Job OverviewCatalyst Clinical Research LLC is seeking a highly skilled Senior Clinical Research Associate to join our team. As a key member of our clinical research team, you will be responsible for monitoring clinical trial programs and managing regional clinical trial sites.Key Responsibilities:Monitor clinical trials according to monitoring plans to...

  • Global Decentralized Clinical Trials Sales Director

    7 days ago

    Raleigh, North Carolina, United States IQVIA Full time

    Job OverviewIQVIA is seeking an experienced Senior Director to drive the growth of our Decentralized Clinical Trials solutions. This includes creating sales strategies, advocating for the use of DCT, interacting with executives to promote our solutions, and representing IQVIA at industry conferences to establish thought leadership.Key...

  • Clinical Research Nurse Specialist

    4 weeks ago

    Raleigh, North Carolina, United States UNC HEALTH Full time

    Job Summary:We are seeking a highly skilled Clinical Research Nurse Specialist to join our team at UNC Health. As a key member of our research team, you will play a critical role in ensuring the success of our clinical trials.Key Responsibilities:Provide education and communication on clinical research activities to patients, families, and healthcare...

  • Senior Clinical Data Specialist

    4 weeks ago

    Raleigh, North Carolina, United States Biodata Partners, Inc. Full time

    Job Summary:At Biodata Partners, Inc., we are seeking a highly skilled Senior Medical Coder to join our team. As a Senior Medical Coder, you will be responsible for performing dictionary coding in accordance with study specific coding conventions using MedDRA and WHO Drug within various coding systems. You will manage end-to-end delivery of clinical data...

  • Clinical Care Specialist

    4 weeks ago

    Raleigh, North Carolina, United States Zachary Piper Solutions Full time

    Piper Clinical Solutions is seeking a skilled Clinical Care Specialist to join a community-based team delivering mental health resources in Wake County, North Carolina. The specialist will be a member of a multidisciplinary team of healthcare professionals providing clinical support to patients in inpatient/outpatient facilities, and in their homes. This...

  • Clinical Research Director

    4 weeks ago

    Raleigh, North Carolina, United States Piper Companies Full time

    Job Title: Clinical Research DirectorPiper Companies is seeking a highly experienced Board-Certified Hepatologist to lead clinical development and execution of hepatology and gastroenterology clinical trials as a part-time Principal Investigator. This role is part-time, with hours expected per week, and can be completed onsite in Raleigh, NC based on the...

  • Civil Construction Document Specialist

    3 weeks ago

    Raleigh, North Carolina, United States Hamilton-Ryker Full time

    At Hamilton-Ryker, we pride ourselves on our commitment to quality and our small company feel, despite having over 5,000 employees in 90 offices. Our core values and purpose are the foundation of a culture that has yielded success since 1967.We have been recognized 15 times as one of the top companies to work for. Our firm provides a wide range of...

  • Clinical Research Dermatologist

    2 weeks ago

    Raleigh, North Carolina, United States M3 Full time

    Mission StatementMission of the Role:M3 seeks a clinical research dermatologist to provide clinical mentorship and leadership for clinical development and clinical trials conduct within our organization. As a Clinical Research Physician/Dermatologist, you will operate in a wide range of aspects in clinical and pharmaceutical medicine and with patients,...

  • Clinical Research Nurse

    4 weeks ago

    Raleigh, North Carolina, United States UNC Health Care Full time

    Clinical Research Nurse Job SummaryWe are seeking a skilled Clinical Research Nurse to join our team at UNC Health Care. As a Clinical Research Nurse, you will play a critical role in ensuring the success of our clinical trials by providing education and communication on research activities and ensuring compliance with protocols and procedures.Key...

  • Clinical Research Nurse

    4 weeks ago

    Raleigh, North Carolina, United States UNC Health Care Full time

    Clinical Research Nurse Job SummaryUNC Health Care is seeking a skilled Clinical Research Nurse to join our team. As a Clinical Research Nurse, you will play a vital role in ensuring the success of our clinical trials by providing education and communication on research activities and ensuring compliance with protocols and procedures.Key...

  • Medical Documentation Specialist

    1 month ago

    Raleigh, North Carolina, United States Scribe-X Full time

    Job OverviewScribe-X offers a unique opportunity for individuals to gain clinical experience and preparation for a career in medicine. As a Medical Scribe, you will work alongside healthcare providers to document patient encounters in real-time, developing essential skills and knowledge in EMR systems and patient documentation procedures.Key...

Clinical Trial Document Specialist

4 weeks ago

Raleigh, North Carolina, United States AA2IT Full time
Job Summary

AA2IT is seeking a highly organized and detail-oriented Clinical Trial Document Specialist to oversee the handling of clinical trial documents in the Trial Master File (TMF). The ideal candidate will ensure adherence to quality standards, regulatory requirements, and Standard Operating Procedures (SOPs).

Responsibilities
  • Maintain and foster working relationships and open communication between departments
  • Prepare and inventory files for off-site storage, if applicable
  • Participate in TMF audits including preparation and follow-up
  • Prepare inventories, assist with quality checks and reconciliation of files during the study and at study closure
  • Ensure the security and compliance of all documents related to active and archived projects
  • Receive and inventory applicable project documents in the TMF
  • Process, scan, index, route and maintain applicable project documents for the TMF in accordance with quality standards and relevant SOPs
  • Draft project specific TMF Plan and structure at the beginning of the trial as well as maintain and update TMF plan throughout the trial
  • Provide ongoing training/feedback to the team on topics related to Good Documentation Practices (GDP), ICH-GCP, pertaining to TMF and document management per study team requirements
  • Provide study team reports or updates regarding status of TMF on a regular basis
Qualifications
  • Education in life sciences or medical health or other comparable professional qualifications
  • Bachelor's degree in life science or medical health preferred
  • Experience in document management
  • Experience in electronic trial master file (eTMF)
  • Knowledge in clinical research and in the conduct of clinical trials
  • Knowledge in relevant regulations (ICH GCP, EU CTR, MDR, FDA, etc.)
  • Knowledge of Good Documentation Practices (GDP)
  • Knowledge of the preparation and processing of documents for clinical trials
  • Excellent keyboard skills, with experience using Microsoft Office (Word, Excel, Power Point, Outlook) applications to prepare charts, tables, forms, reports
  • Flexibility and ability to support various clinical trials and teams in parallel