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Position Summary

The Clinical Research Coordinator functions as an integral part of the Research Team in clinical trial management at Oncology Consultants. The Clinical Research Coordinator is involved in multiple aspects of the research process under the general supervision of the Clinical Research Manager and the Research Director.

Key Performance Areas

KPA 1 – Study Start-Up, Regulatory & Site Initiation

Responsible for supporting study feasibility, regulatory submissions, and study initiation activities to ensure compliance with protocols, regulatory requirements, and institutional policies.

• Applies knowledge of study design to evaluate protocol feasibility at the site.

• Assists Regulatory staff in preparing and submitting documents to Institutional Review Board (IRB).

• Participates in study site initiation activities.

• Attends and participates in investigator meetings and clinical trial conferences as directed.

• Documents protocol deviations and exemptions.

• Prepares for and participates in FDA inspections.

• Communicates effectively with IRBs, sponsors, investigators, and research team members.

KPA 2 – Patient Recruitment, Screening & Enrollment

Responsible for patient recruitment, screening, eligibility verification, and enrollment activities in accordance with study protocols.

• Participates in subject/patient recruitment and evaluation of eligibility.

• Reviews and verifies required source documents to confirm study eligibility.

• Reviews inclusion/exclusion criteria with investigator to assure subject eligibility.

• Conducts interviews to assess subject ability and willingness to complete study procedures.

• Maintains patient screening and enrollment logs.

• Reviews protocol requirements, informed consent, and follow-up procedures with potential study subjects.

• Follows randomization procedures per protocol.

• Demonstrates commitment to superior customer service and patient-centered communication.

KPA 3 – Clinical Trial Coordination & Patient Care Activities

Responsible for coordinating study visits, performing clinical procedures, and ensuring protocol compliance throughout the research process.

• Ensures study drugs are dispensed per protocol and maintains drug accountability records.

• Reviews returned drugs for compliance and documents findings.

• Provides direct care in study compliance throughout the research experience.

• Performs peripheral venipuncture per organizational standards.

• Ensures proper specimen collection, batching, processing, and shipping per protocol.

• Works collaboratively with site staff to process specimens.

• Prepares and ships study-required specimens per protocol manual.

• Obtains test results and reports to the physician investigator.

• Attends clinic visits with the investigator and assists in following study guidelines.

KPA 4 – Data Management, Documentation & Monitoring Support

Responsible for maintaining accurate study documentation, source documentation, and supporting sponsor monitoring and audit activities.

• Obtains and reviews original source documents (recordings, scans, test results, procedure reports).

• Abstracts data from medical records and other documentation to study forms and flow sheets.

• Completes and maintains study documentation and case report forms.

• Resolves data queries.

• Schedules sponsor monitoring visits.

• Prepares case report forms and source documents for sponsor and audit review.

• Assists with audit preparation and monitoring visits.

KPA 5 – Research Program Support, Education & Administrative Support

Responsible for supporting research department operations, education, budgeting support, and departmental coordination activities.

• Participates in educational and training activities and continuing education.

• Supports and assists management team with department projects.

• Assists in maintenance of budgetary data for each clinical trial.

• Assists in planning department coverage for clinic visits, data management, and meetings.

• Maintains professional communication with internal and external customers.

• Demonstrates strong verbal and written communication skills.

Position Qualifications

Education

• Degree in the life sciences or health sciences such as Registered Nurse (R.N.), Doctor in Philosophy (Ph.D.), Medical Doctorate (M.D.), or other related degree.

Minimum Relevant Experience

• 2 or more years of clinical research experience.

Certifications/Licenses

• Continuing education participation is expected, and research certification through a recognized national organization (SOCRA, ACRP) is encouraged.

• NIH protection of Human subjects online course will be required annually.

• IATA training will be required every 2 years.

Travel: 0 - 25%

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