Phase I Oncology Clinical Research Coordinator

PURPOSE: Responsible for performing diverse clinical and administrative tasks that requires a sound analysis, judgment and a high level of knowledge of specific study protocols, GCP guidelines and FDA regulations. This position is also responsible for coordination and management of clinical study activities in a clinical study and directly reports to the Manager of Clinical Research and the Principal Investigator.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Conduct all clinical studies according to FDA regulations and guidelines.
• Obtain detailed knowledge of all components of study protocol through independent analysis and review of study to complete all study activities correctly and completely.
• Maintain Investigator Site files ensuring all appropriate regulatory documents are completed, updated/revised as necessary and filed appropriately.
• Review with all members of the research team study procedures prior to initiation date to ensure an understanding and acceptance of roles and responsibilities for proper performance during the study.
• Perform a variety of activities to assist the investigator in conducting a clinical trial (i.e. vital signs, patient specimen processing, data entry).
• Identification and screening of potential patients for specified clinical trials accurately, on a timely basis, and within the recruitment period.
• Schedule all patient visits and procedures to meet protocol requirements. Provide instructions and dates to patients to ensure proper protocol compliance.
• Ensure that protocol activities performed by research staff (including the Investigator) and the patient meet protocol requirements.
• Ensure that all laboratory samples are collected properly, and tests are performed by the designated laboratory facility accurately and on a timely basis.
• Distribute study medication according to the protocol requirements and maintain accurate and complete records.
• Serve as liaison between caregivers and patients.
• Complete all necessary source documentation required by the protocol. All documentation must be entered timely and accurately.
• Complete CRF entries in a timely manner, ensuring that all queries are addressed and resolved as appropriate.
• Report any and all adverse events experienced by patients appropriately and according to what are required by the protocol.
• Strict patient confidentiality is to be maintained.

COMPETENCIES:

To perform the job successfully, an individual should demonstrate the following competencies:

• Planning/Organizing:
• Prioritize and plan work activities.
• Use time efficiently.
• Set realistic goals and objectives.
• Problem Solving:
• Identify and resolve problems in a timely manner.
• Gather and analyze information skillfully.
• Develop alternative solutions.
• Judgment:
• Includes appropriate people in decision making process.
• Exhibits sound and accurate judgment.
• Make timely decisions.
• Multi-tasking:
• Handle a number of different tasks simultaneously.
• Quality:
• Demonstrate accuracy and thoroughness.
• Monitor own work to ensure quality.
• Service Orientation:
• Respond promptly to patients’ needs.
• Interact with patients, sponsor companies and others on a regular basis.
• Adaptability:
• Able to deal with frequent change, delays, or unexpected events.
• Dependability:
• Commit to long hours of work necessary to reach goals.
• Complete tasks on time or notifies appropriate person with an alternate plan.
• Teamwork:
• Balance team and individual responsibilities.
• Contribute to building a positive team spirit.
• Put success of team above own interests.
• Quality Management:
• Look for ways to improve and promote quality.
• Demonstrate accuracy and thoroughness.
• Safety and Security:
• Observes safety and security procedures.

EXPERIENCE (must meet one of the following):

• At least 1 year of research coordination preferred
• ACRP certification preferred

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Education:

• Bachelor's (Preferred)

Experience:

• Clinical Research: 1 year (Preferred)

Ability to Commute:

• Huntersville, NC 28078 (Required)

Work Location: In person