Aktuelle Jobs im Zusammenhang mit Clinical Research Data Specialist I - Ingelheim am Rhein, Rheinland-Pfalz - Georgetown University in Qatar


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  • Ingelheim am Rhein, Rheinland-Pfalz, Deutschland Georgetown University in Qatar Vollzeit

    Job SummaryWe are seeking a highly skilled Clinical Research Nurse I to join our team at Georgetown University's Lombardi Comprehensive Cancer Center. The successful candidate will be responsible for managing the overall coordination of assigned clinical trials throughout the trial lifecycle.Key ResponsibilitiesCollaborate with investigators and senior study...


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  • Ingelheim am Rhein, Rheinland-Pfalz, Deutschland Georgetown University in Qatar Vollzeit

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  • Ingelheim am Rhein, Rheinland-Pfalz, Deutschland Georgetown University in Qatar Vollzeit

    Georgetown University in Qatar seeks a highly skilled Research Data Coordinator I to join its team in the Lombardi Comprehensive Cancer Center. The successful candidate will be responsible for data management for phase I, II, and III oncology clinical trials, including collection of data from source documents and medical records, completion of case report...


  • Ingelheim am Rhein, Rheinland-Pfalz, Deutschland Georgetown University in Qatar Vollzeit

    Georgetown University Medical Center is seeking a highly skilled Research Data Coordinator I to join our team in the Lombardi Comprehensive Cancer Center.Job OverviewThe Research Data Coordinator I will be responsible for managing data for phase I, II, and III oncology clinical trials. This will include collecting data from source documents and medical...

Clinical Research Data Specialist I

vor 2 Monaten


Ingelheim am Rhein, Rheinland-Pfalz, Deutschland Georgetown University in Qatar Vollzeit

Position Overview

Located in a vibrant academic environment, Georgetown University in Qatar is dedicated to advancing knowledge and fostering a commitment to social responsibility. Our institution thrives on collaboration among exceptional individuals who are passionate about research and making a meaningful impact.

Role Summary

The Research Data Coordinator I plays a crucial role in managing data for oncology clinical trials conducted at the Lombardi Comprehensive Cancer Center. Responsibilities include:

  • Facilitating all facets of clinical research data management for trials within the Clinical Research Management Office (CRMO), encompassing data collection from primary documents and medical records, and ensuring completion of case report forms as per sponsor specifications.
  • Overseeing trials of varying complexities and disease indications.
  • Collaborating effectively with trial stakeholders and internal study teams, including physicians, regulatory personnel, study coordinators, nursing staff, laboratory technicians, and pharmacy teams.
  • Reviewing and analyzing medical records to extract pertinent data for all assigned research protocols, including industry-sponsored, national, and investigator-initiated studies.
  • Accurately documenting data in electronic or paper Case Report Forms (eCRFs/CRFs) while adhering to contractual timelines and site Standard Operating Procedures (SOPs).
  • Ensuring timely query resolution with appropriate oversight from physicians and clinical study teams.
  • Requesting and uploading radiological images into sponsor-designated imaging platforms in accordance with study protocols.
  • Resolving imaging-related queries with the support of the clinical study team.
  • Collecting and organizing source documents in both electronic and paper formats in line with site policies.
  • Maintaining accuracy of data entered in the Clinical Trials Management System (CTMS) with patient information and key dates, while interfacing with study team members to address discrepancies.
  • Coordinating sponsor monitoring and study close-out visits.
  • Providing assistance during internal and external monitoring and auditing preparations, including supporting data deficiency corrections and developing corrective action plans post-audit.
  • Communicating effectively with pharmaceutical sponsors, study monitors, auditors, physicians, and study team members.
  • Working closely with physicians and study coordinators to uphold protocol integrity.
  • Participating in protocol-related training and completing all required study training within designated timeframes.
  • Preparing for and engaging in site initiation visits.
  • Ensuring ongoing compliance with all departmental, institutional, and federal regulations.
  • Maintaining controls to guarantee the accuracy, completeness, and confidentiality of research data.
  • Upholding confidentiality standards for all potential and enrolled study participants, in compliance with federal Health Insurance Portability and Accountability Act (HIPAA) regulations.

Work Interactions

  • Clinical Research Manager
  • Disease Group members: Principal Investigators, Physicians, Clinicians
  • CRMO members: Clinical Research Nurses, Clinical Research Coordinators, Data Managers, Regulatory Coordinators, Laboratory Technicians
  • External department clinicians and staff: Infusion Nurses, Oncology Pharmacists, hospital staff
  • Clinical trial sponsors, auditors, and study monitors

Qualifications

  • High School diploma or equivalent certification.
  • Up to 2 years of relevant experience.
  • Ideal candidates demonstrate the ability to work independently and collaboratively within a team, possess strong attention to detail, and exhibit reliability with the capacity to prioritize competing responsibilities.

Compensation

The anticipated salary for this position is approximately $26.03 per hour. Compensation is influenced by various factors, including individual qualifications, experience, education, skills, and certifications, as well as the institution's business needs.

Benefits

Georgetown University offers a comprehensive benefits package that includes medical, dental, vision, disability and life insurance, retirement savings, tuition assistance, work-life balance benefits, employee discounts, and various voluntary insurance options.