Phase I Oncology Clinical Research Coordinator

Benefits

Qualifications

• •To perform the job successfully, an individual should demonstrate the following competencies:
• •Set realistic goals and objectives
• •Able to deal with frequent change, delays, or unexpected events
• •Dependability:
• •Commit to long hours of work necessary to reach goals
• •Put success of team above own interests
• •Huntersville, NC 28078 (Required)
• •4 more items(s)

Responsibilities

• •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
• •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
• •Prioritize and plan work activities
• •Use time efficiently
• •Problem Solving:
• •Identify and resolve problems in a timely manner
• •Gather and analyze information skillfully
• •Develop alternative solutions
• •Includes appropriate people in decision making process
• •Exhibits sound and accurate judgment
• •Make timely decisions
• •Multi-tasking:
• •Handle a number of different tasks simultaneously
• •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
• •Complete tasks on time or notifies appropriate person with an alternate plan
• •Balance team and individual responsibilities
• •Contribute to building a positive team spirit
• •Look for ways to improve and promote quality
• •Demonstrate accuracy and thoroughness
• •Observes safety and security procedures
• •38 more items(s)