Under direction of assigned Principal Investigator (PI) and Project Manager (PM), the Senior CRC will independently coordinate and be accountable for the overall administration of clinical research efforts for a variety of advanced research projects and clinical trials. The incumbent will provide leadership to lower level clinical research coordinators and/or other support personnel. The incumbent will be responsible for coordinating and monitoring clinical trials including providing all aspects of protocol oversight, including but not limited to screening for patient eligibility, consent review, data collection and analysis, ensuring protocol compliance, adverse drug/therapy reaction reports, monitoring patient treatment and toxicities, laboratory and specimen collection, processing, submission, and maintenance of accurate and complete clinical research files.

Coordinate development of cooperative group affiliation including credentialing, data entry support, and coordination of training. Assist the regulatory department with Human subjects' submissions, renewals, and safety reports. Oversee research protocol writing, start-up procedures, implementation, recruitment, and close out procedures. Directly communicate with assigned physicians and disease groups, including attending weekly meetings and tumor boards as assigned. Provide direct assistance to the Research Director in reviewing and verifying research account statements, professional fee statements, and invoicing. Coordinate research efforts with the Moores Cancer Center team through close communication and collaboration with the Associate Administrative Director and Administrative Director.

Act as a liaison with other departments and community clinics or agencies for the purpose of implementation of studies. Assure compliance with state and federal regulatory guidelines. Oversee the quality of the medical and clinical research data. Provide direction and guidance to investigators. Provide education and information to the general public concerning the ongoing clinical trials. Assist PIs with proposals, progress reports and manuscripts. Work closely with federal and state regulatory officials.

The incumbent will work with leadership on developing, improving, and implementing study protocols, offering insight at the regulatory, operational, clinical, and technical levels. Incumbent will oversee the conduct of Clinical Trials by ensuring protocol compliance, filing adverse drug reaction reports, monitoring patient treatment and toxicities, laboratory and specimen submission, and maintenance of accurate and complete clinical research files. Other duties assigned as needed.

• Seven years of related experience, education/training, OR a Bachelor's degree in related area plus three years of related experience/training.

• Clinical Trial Professional certification from a professional society within one year in position.

• Demonstrated experience in research protocol start-up procedures, including: study feasibility, study activation and IRB processes, and qualification procedures. Demonstrated experience in clinical trials research including budget negotiations and invoicing per clinical trial agreement.

• Demonstrated experience with research protocol in order to screen patients for eligibility, initiate treatment plan, collect, process, and ship specimens, and orient participating physicians.

• Experience in medical assessment and patient interviewing to determine toxicities related to protocol management. Experience with laboratory procedures and values and experience in interpreting them to determine patient eligibility and potential toxicities.

• Experience interpreting medical charts and abstracting data from medical records.

• Thorough knowledge of experimental protocols, data gathering, protocol design and evaluation.

• Strong knowledge of investigational protocols especially with radiation oncology protocols (data management, query resolution, protocol design, protocol writing, evaluation, and protocol implementation). Working knowledge of medical and scientific terminology.

• Significant experience completing clinical trials case report forms via hard copy and online.

• Significant clinical trials research experience.

• Proven ability to find creative and innovative solutions to adjusting needs of the center. Ability to be resourceful and to understand the overall nature of work/responsibilities to establish useful resources and University contacts.

• Ability to discern items that can be handled independently and those which require attention of supervisor, including ability to quickly determine subject matter of material and necessary action to be taken in a timely manner.

• Experience working with FDA policies regulating clinical trials.

• Proven ability to problem solve and resolve conflict.

• Meticulous attention to detail.

• Excellent ability to organize/prioritize workload effectively to meet deadlines in an environment with multiple interruptions and changing priorities.

• Excellent interpersonal, as well as written and verbal communication skills (using grammatically correct written English and accurate typing) to interact with a variety of personalities at all levels of the organization, exercising tact, mature judgment, diplomacy, and flexibility to promote positive working relationships and job effectiveness. Skill at negotiating with various personalities and developing internal and external network of contacts. Excellent phone etiquette skills.

• Computer proficiency, including working knowledge of word processing, spreadsheet software (Microsoft Office) and internet browser applications. Experience in conducting searches on the internet.

• Demonstrated administrative experience, skill to coordinate complex activities and to use independent judgment to organize and prioritize office functions.

• Knowledge of National Institute of Health (NIH), Good Clinical Practice (GCP), Injury and Illness Prevention Program (IIPP), Human Resource Protection Program (HRPP), IATA Shipping of Blood Specimens, and Bloodborne Pathogens.

• Knowledge of cost accounting as applied to both University and Medical Center functions. Demonstrated knowledge of medical billing and collections guidelines and procedures.

• Knowledge of hematology/oncology or radiation oncology. Ability to differentiate various cancers by stage, histology, and site to determine patient eligibility for protocols and assure accurate randomization.

• Employment is subject to a criminal background check and pre-employment physical.

• Must be able to work various hours and locations based on business needs.