Clinical Research Coordinator

American Oncology Partners, PA; United States; On-site; USD 44,000 - 74,000; Full time

Job summary

Oncology Consultants is seeking a Clinical Research Coordinator to support trial management at our Medical Center. The role involves study start-up, regulatory submissions, patient recruitment, and coordinating study visits under supervision of the Clinical Research Manager and Research Director.

Responsibilities include data management, source documentation, drug accountability, and collaboration with IRBs, sponsors, and investigators to ensure protocol compliance.

Qualifications

• Minimum 2+ years of clinical research experience.
• SOCRA/ACRP certification encouraged; NIH protection course annually.
• IATA training required every 2 years; travel 0-25%.
• Educational background in life sciences or health sciences.

Responsibilities

• Support study start-up, regulatory submissions and site initiation.
• Recruit, screen and enroll subjects per protocol; verify eligibility.
• Coordinate study visits and drug accountability; assist in data collection.
• Maintain study documentation, source docs, and sponsor monitoring support.
• Provide education and administrative support to the research department.

Skills

Regulatory submissions

IRB coordination

Study start-up

Clinical research coordination

Education

Life sciences degree

Job description

Location: Oncology Consultants - Medical Center CCO Office Hiring Range: $43,680.00 - $73,920.00

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%

AON Overview

American Oncology Network AON is an alliance of physicians and veteran healthcare leaders dedicated to ensuring the long-term success and viability of oncology diagnosis and treatment in community-based settings. It is the fastest growing national network of community oncology practices delivering local access to exceptional cancer care. AON serves its expanding network of partner practices by providing proven practice management expertise. Our employees across the country work together to empower physicians to make cancer care better. By driving integrated, collaborative care, we are proudly helping community oncologists deliver the highest quality care to every patient. Cancer touches everyone. Being able to make a difference in the lives of those fighting this disease is something our employees at AON cherish and never take for granted. A career in oncology offers all sorts of rewards. But working at AON offers employees more than most. As a fast-growing national company, the opportunity to join a national workforce with flexible work options is available. We offer competitive compensation packages that include comprehensive health insurance with a robust provider network. Our 401k, which offers a 100% match and investment options, is available to full-time and part-time staff members, and we feature a generous Paid Time Off (PTO) program. At AON, we offer you more than a job, we offer you a career. As a network of independent oncology practices working together as one, we host annual summits each year, providing our employees a chance to collaborate with AON peers from across the country. Promoting from within is a priority ́s Team and we support our team members continued growth through professional development programs and tuition assistance.