CLINICAL RESEARCH COORDINATOR II (7)

General Responsibilities

To serve as coordinator for studies and provide support to other team members within the confines of the protocol as directed.

To support screening and participant eligibility determination, working with more senior team members to ensure compliance.

To conduct activities in accordance with the protocol, regulations and Good Clinical Practice (GCP).

To assist with the study life cycle from start-up to closure, i.e., collecting and recording data, recruiting and performing follow-up with participants, scheduling visits and assisting in coordination of lab and fieldwork.

Key Duties & Responsibilities

• Serves as a liaison with medical staff, University Departments, ancillary departments, and/or satellite facilities.
• Organizes patient enrollment planning.
• Conducts quality assurance activities.
• May compile and analyze data.
• Develops and implements procedures, maintains records, tracks progress, and conducts quality assurance on data collected.
• Affords support in the recruitment of participants through screening efforts, including the conduction of the consent process according to regulatory guidelines.
• Carefully coordinates care and/or follow-up functions of the study, including planning and developing related activities.
• Arranges access to study medications, as needed, including authorization for prescriptions.
• Employs strategies to maintain recruitment and retention rates.
• Involves in the study feasibility process and may assist in budget development and billing procedures.
• Prepares and submits multiple levels of research documentation (i.e., IRB, IND, or FDA submissions, educational materials, reports, grant renewal reports, and study forms).
• May manage investigational products (IP), including it’s administration to participants.
• Employs the required system (including personnel) for handling, dispensing, and documenting IP for sponsored protocols.
• In conjunction with Investigators, plans and implements the clinical protocol's goals and objectives.
• Compiles, edits, and proofs written reports for both internal and external administrative offices.
• Provides data for the creation of study budgets as needed.
• Completes Case Report Forms (CRF) according to protocol.
• Documents Adverse Events (AEs) and Serious Adverse Events (SAEs) as required by protocol and regulatory guidance.
• Assists with the development of standard operating procedures (SOPs) for data quality assurance.
• Performs vendor analysis and equipment configuration as needed.
• May perform a variety of medical procedures and assist in developing orders in the Electronic Medical Record (EMR).
• Under the oversight of the Investigator, develops protocols, identifies efficiencies, and improves processes.
• Serves as a mentor and guides junior staff, including student assistants.
• Maintains compliance with federal, state, and accrediting agencies (sponsors).
• Maintains any required documentation.
• Has a working knowledge of institutional and departmental policies and processes.
• Processes and maintains lab specimens.
• Manages site supplies and performs administrative duties in support of research conduction as needed.
• Attends study, departmental, and institutional trainings and meetings as required.
• Performs other duties as assigned.

Qualifications

• Bachelor's degree in a related field and three (3) years of related experience required.
• Work experience may substitute for education requirement.
• Priorities Clinical research experience.
• Ability to lead others in the coordination of research activities involved in conducting Oncology clinical trials.
• Knowledge of clinical research regulatory/compliance affairs.
• Problem-solving skills.
• Working knowledge of related scientific and clinical terminology.
• Leadership skills.
• Presentation skills.
• Prioritization skills.
• Organizational skills.
• Written and verbal communication skills.
• Ability to work as part of a team.
• Ability to walk minimally one mile a day and lift up to 15 pounds a daily.

Benefits

The benefits package includes health insurance, retirement savings plan, paid time off, and more.

Pay

Annual Salary Range: $50,050 - $81,330

Schedule

Day/1st Shift Work Arrangement (final schedule to be determined by the department/hiring manager)