Job Summary

This position provides coordination of investigational and research protocols. Coordinates operational aspects of research projects including project preparation, subject recruitment, protocol execution, data collection, and coordination and database entry.

Essential Functions

• Promotes research study initiation and review. Acts as the project representative and professional resource for coordination of staff, sponsors, research institutions, contract research organizations, regulatory agencies, and involved institutional departments. Reads and evaluates clinical research protocols. Attends departmental, committee, and sponsor meetings for the purpose of gathering new or revised information concerning existing or potential clinical research projects.

• Ensures that the clinical research staff and/or students conduct the clinical aspects of the projects appropriately and adhere to the clinical trial schedule, which may include: maintaining, dispensing and recording drug and medical device supplies according to regulations; assisting in obtaining informed consent from project participants; assisting in the development and implementation of case report forms; instructing volunteers on protocol requirements and explaining procedures and consent forms; performing research patient registration; ensuring that clinical research staff conduct the clinical aspects of the projects appropriately and adhere to the schedule of the clinical trials; serving as an advocate for the research participant, assisting them through the research process; and/or, performing other related activities.

• Develops and maintains regulatory and legal documents per guidelines and regulations of the research/study sponsor and the participating institution per IRB, FDA, PHA and other applicable regulatory agencies. Assists in annual reporting to Federal agencies as required.

• Performs accurate data collection and reporting according to protocol requirements and completes applicable forms and/or other required reports in a timely manner. Facilitates and conducts site reviews with sponsors and other related agencies for the purpose of evaluating the accuracy and quality of the collected data. Develops and implements patient tracking and follow-up systems. Coordinates with participating physicians offices and staff for patient follow-up.

• Assists in educating patients about research studies and in obtaining informed consent from project participants. Develops and maintains educational tools, educates research team members and assists staff in the conduct of the investigational therapy. Performs medical record reviews. Assists with patient recruitment, screening, diagnostics, treatment and education. Utilizes clinical knowledge and assessment skills necessary to evaluate, report and record accurate medical information, including responses to therapy.

• Assists in the development and maintenance of budget and/or contract agreements. Follows policy requirements for reporting patient enrollment in an effort to ensure compliance with billing. Assists in the development of accounting reports and in coordination of billing systems.

• Coordinates and safely implements research activities through interactions with research staff, internal and external investigators, study sponsors and Institutional Review Board (IRB).

• Participates in the development of clinical research protocols. Performs accurate and timely data collection and reporting according to protocol requirements. Facilitates and conducts site reviews by sponsors and other related agencies for the purpose of monitoring the accuracy and quality of the collected data. May hire, train, conduct performance reviews, and direct the workflow for the department staff.

Minimum Qualifications

Must possess a thorough knowledge of nursing and healthcare as normally demonstrated through the completion of a Bachelors Degree in Nursing.

Requires a current Registered Nurse (R.N.) license. Possession of or ability to obtain a Clinical Research Coordinator Certification (CRCC) within a reasonable timeframe.

Experience typically gained through five years clinical research experience, including three years of experience related to clinical area in which research study is based. Regulatory knowledge regarding the conduct of clinical research or health care operations required. Previous relevant experience working in a clinical research setting. Knowledge of medical and clinical terminology. Excellent organizational and task management skills and the ability to maintain confidentiality of patient and study information. Ability to maintain knowledge of Federal and State regulations governing practice as well as Institute policies and procedures related to medical and nursing practice. Excellent human relations, organizational and communication skills.

Ability to conduct computer-based literature searches is required.

Preferred Qualifications

Masters Degree or advanced certificate degrees preferred.

Additional related education and/or experience preferred.