Clinical Research Data Coordinator Jobs

2-3 years of experience in clinical research data entry

Strong organization and communication skills

Ensure data is correctly input into the system and quality of clinical research is maintained

Prepared for and participates in internal and external audits and action plans needed from these results.

Utilizes Query Trackers to reconcile, clarify, and complete data issues

Direct others with interpretations of rules and regulations

Experience with MDM (Master Data Management).

Data & Analytics leader with 15+ years of industry experience.

At least 5 years of experience with clinical trial domain experience is required.

Experience with modern cloud analytics platforms such as Snowflake and/or Databricks is required.

Some MDM experience will be highly desirable.

Experience with ADF (Azure Data Factory) will be desirable.

Minimum 3-5 years of experience in a pharmaceutical/CRO setting with at least 3-4 years of experience in Data Management.

Liaise closely with the Lead Data Manager to report study progress and any issues outstanding.

Assist the Lead Data Manager with the preparation of study documentation.

Assist the Lead Data Manager with the creation and validation of Manual and SAS checks.

Proficient knowledge of CDISC CDASH and SDTM terminology

Attend study update meetings or calls with the study sponsor as needed.

Maintains patient tracking spreadsheets to ensure data entry requirements are met.

Responsible for prompt and accurate data entry for protocols, including Serious Adverse Events.

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Assists in the coordination of initiation, site evaluation, monitoring visits, and audits required by the sponsor.

Works with research team in managing the visits of active and follow up subjects on research protocols.

Processes study specific data collection documents into case report forms.

Minimum of 1+ years of work experience in research and/or data analysis and management required

Demonstrated experience with large data sets and data management

Support in efforts related to the ATLAS data system and databases. Collaborate with technical staff on effective, long-term data management processes.

Support in the tracking and resolution of any data management issues as needed.

Knowledge of data visualization software Power BI preferred but not required

Strong oral and written communication skills

Background Check and Live Scan

Legal Right to work in the United States

California Child Abuse and Neglect Reporting Act

$32.12 - $52.92 (Hourly Rate)

May require travel to satellite sites.

- Exp with Clinical research trial documentation and clinical data management.

- Experience with clinical research trials in med devices.

- Experience using any kind of online eTMF(Electronic Trial Master File).

- Working knowledge of Microsoft office tools - Excel, word, outlook.

- Knowledge knowledge on using statistics.

- SAS experience is nice to have (running the program).

Experience using EMR and strong computer skills preferred.

You will maintain working knowledge of protocols and eCRF completion guidelines for assigned projects.

You will regularly review protocol, amendments or clarifications, and revisions for eDC data entry.

You will support non-treatment studies. You will abstract and analyze data from necessary sources to complete the EDC and resolve queries.

A strong understanding of research protocols and implementation.

Attention to details and accuracy

Administration and management of EDCs, including creation of eCRFs, study configuration, and UAT

Creation and interpretation of study management reports

Familiarity with Electronic Data Capture systems and data management

Solid skills in data entry, monitoring /QA and data analysis/statistics

Manage user accounts and provide support to sites

Minimum 3years’ experience in a related healthcare position

Demonstrates excellent oral and written communication skills when communicating by phone, computer-generated reports and/or face to face interactions.

Proactively communicates with ancillary collaborators involved in the research projects.

Provides regular status reports of all projects and database activities, including accrual trends and patients in screening.

Consults with principal investigators and other department personnel regarding the status of ongoing projects.

Follow up with patients during follow up visits for adverse event notation and collection of Patient Reported Outcomes (PRO's).

Generate patient orders in electronic medical records, while following up with patients for scheduling/re-scheduling of appointments.

Coordinates and reviews new and existing protocols for data management requirements.

Performs other duties related to data management as needed.

Maintains current knowledge on EPIC tools for research queries and data extraction.

Employment Status: Part-Time Benefits Eligible

Work Location: Remote (within Texas only)

**This is a part-time 20 hour benefit eligible position**

Maintain to Caris and Site requirements for source document management and request for information.

Experience in both small and large scale project planning and reporting with strong communication and presentation skills.

Position requires 3-5 years of experience in data collection activities within a GCP/clinical research regulatory environment.

Knowledgeable in critical elements for success in clinical trials. GCPs, ICH, and Code of Federal Regulations.

Clinical study experience in the field of Oncology.

Experience in providing training for both internal and external staff with a mentorship approach for less experienced colleagues.

Provide data coordination and data management support for Nelson Lab research studies.

Comfortable representing data-related, data management interests in team-wide conversations

Experience providing educational support and training to research investigators and staff

Interface with the Principal Investigators, project managers and staff, and external collaborators on a routine basis.

Excellent computer skills, including expertise in Microsoft Office software (e.g., Excel), R and/or Python, SPSS, and familiarity with SAS and STATA

Experience in formatting and exporting data for statistical analyses