Clinical Research Coordinator II

DALLAS VA RESEARCH CORPORATION; Dallas (TX); On-site; USD 60,000 - 95,000; Full time

Job summary

DALLAS VA RESEARCH CORPORATION is seeking a Research Coordinator to support one or more studies under light supervision. The role involves conducting procedures, maintaining patient consent, and ensuring compliance with regulatory standards while delivering high-quality data and care for veterans.

The Coordinator may supervise junior staff, manage data entry, and coordinate with investigators to meet study goals.

Qualifications

• More than 4 years of research experience; or
• 3+ years of research experience with a Bachelor Degree in a relevant area; or
• 3+ years of research experience with an LVN; or
• Greater than 1 year of research experience with a Masters or Ph.D. in a relevant area.

Responsibilities

• The Coordinator conducts procedures for one or more research studies under light supervision.
• May supervise less-experienced Coordinators or Research Assistants.
• Maintain protection of human subjects while meeting research goals and ensuring superior customer service to veterans.
• Interviews study participants and family members to gather research information
• Reviews eligibility criteria with Principal Investigator or Senior Coordinator
• Performs consent process with patients and handles data entry and enrollment notes
• Coordinates regulatory requirements and safety reports with higher grade staff
• Prepares statistical reports and annual federal/state/local agency reports
• Manages data collection and coordination of samples, lab data, and protocols
• Serves as liaison for annual reports to agencies and IRB amendments

Skills

Research experience

Microsoft Office

Research databases

Education

Bachelor Degree in a relevant area

Masters or PhD in a relevant area

LVN

Tools

Microsoft Office

Research databases

Job description

Education and Experience Requirements:

• Must be eligible to work in the U.S.; H1b visa holders are ineligible
• More than 4 years of research experience; or
• 3+ years of research experience and a Bachelor Degree in a relevant area; or
• 3+ years of research experience and an LVN; or
• Greater than 1 year of research experience and a Masters Degree or Ph.D. in a relevant area; or

SoCRA or ACRP Certification

Highly desirable and counts as one year of experience

Software Requirements

Experience with Microsoft Office and research database products

Responsibilities

The position works under light supervision of the Principal Investigator or more experienced coordinator. The Coordinator is responsible for conducting procedures for one or more research studies. The Coordinator may supervise less-experienced Coordinators or Research Assistants. They will maintain the protection of human subjects while meeting the research goals of each project. Will consistently exhibit behavior and communication skills that demonstrate DVARC’s commitment to superior customer service and dedication to the care of our veterans.

Supervisors

VANTHCS Principal Investigator, DVARC Coordinator Manager and/or Senior Coordinators

Duties:

1. Assists in the design of research survey forms to capture required participant information
2. Interviews study participants and/or family members to gather research information
3. Reviews exclusion/inclusion criteria with the Principal Investigator or Senior Coordinator to ensure subject eligibility
4. Conducts interviews to confirm study eligibility and willingness to follow and complete study procedures and visits
5. Performs consent process with patients, ensuring inclusion and exclusion criteria are met, taking responsibility for all aspects of research completeness, enrollment notes, administrative duties and data entry
6. Develops, coordinates and reviews research study procedures to ensure receipt, completeness and accuracy of study data
7. Coordinates, with the assistance of higher grade staff, all regulatory requirements such as preparing safety reports, adverse event paperwork, FDA compliance, sponsor monitoring and logs, laboratory standards, and maintenance of databases related to regulatory requirements
8. May assist with the study budget and negotiation of participant payments
9. Monitors budget, prepares reimbursement requests, approves expenditures and reconciles study accounts
10. Prepares and submits information in the Case Report Form and submits a billing matrix for funding source and submits to DVARC
11. Prepares statistical reports, charts and graphs as required
12. Assists in preparation of annual reports for federal, state, and local agencies
13. Informs IRB of amendments to research studies
14. Coordinates collection and data management of national research studies from multiple projects by interacting with internal and external research data managers, patients, and physicians for coordination of tissue samples, lab data and protocols, and other statistical information concerning research study subjects
15. Serves as primary liaison and prepares annual reports for federal, state, and/or local agencies.
16. Informs Institutional Review Board of amendments to research studies, and prepares protocols and detailed summaries in lay terms of any new research study
17. May provide full supervision to personnel of lower grades
18. May perform lower risk, less complicated procedures in studies, if directed by Principal Investigator