Major Responsibilities:Performs clinical and administrative coordination of sponsored clinical trials, research protocol/projects, and biospecimen collection studies as applicable. Provides guidance to physicians, clinical staff and research team members. Acts as subject matter expert.Coordinates assigned research studies in collaboration with other team members and key stakeholders, including but not limited to; study start-up, review of study CTA/budget/CTMS, IRB submissions, recruitment, screening, and enrollment of research subjects, development of mechanisms to maximize subject adherence to the research protocol, maintain source documentation, data collection (i.e. development, completion and submission of case report forms (EDC), study drug/device accountability, monitoring of subjects, AE/SAE reporting, study close out, and facilitates quality assurance inspections and audits. Acts as a liaison between sponsor and investigators and as the primary protocol/project contact for team members and clinical staff.Plans, develops and implements educational plans to disseminate protocol/project information with research staff, investigators and clinical staff. Reviews protocol amendments and updates, research related orders (in collaboration with Investigational Drug Services), and study-specific workflows.Ensures that laboratory requirements are being met for specimen procurement, proper collection, processing and shipment of specimens.Serves as Primary Research Coordinator on studies across multiple sites guiding research team members involved in the study and coordinates research activities across sites acting as a preceptor in all areas of AARI.Coaches and mentors Research Coordinators, team members, and other personnel.Assists in the creation, development and implementation of educational training programs, including onboarding activities, orientation, continuing education, and remedial training for team members, as necessary.Develops expertise in research computer applications and assists in the training of applications to other research staff and serve as a subject matter expert. Proactively monitors/evaluates the effectiveness of applications and systems. Attends and participates in educational programs, meetings, and assigned committees.Licensed nurses will utilize advanced assessment skills to identify patient care problems, provide professional nursing care to research patients and support Research Coordinators in performing nursing activities as needed.
Licensure, Registration, and/or Certification Required:Clinical Research Coordinator (CCRC) certification issued by the Association of Clinical Research Professionals (ACRP) when eligible needs to be obtained within 1 year, or Clinical Research Professional (CCRP) certification issued by the Society of Clinical Research Associates (SOCRA) needs to be obtained within 1 year.
Education Required:Bachelor's Degree in Biology, or Bachelor's Degree in Health Science, or Bachelor's Degree (or equivalent knowledge) in Nursing or related field.
Experience Required:Typically requires 5 years of experience in Clinical Research enrolling subjects, conducting subject study visits, maintaining source documents and entering data in multiple electronic data systems.
Knowledge, Skills & Abilities Required:Knowledge of Good Clinical Practices, International Conference of Harmonization, FDA Guidance documents, Department of Health and Human Services regulations, standard operating procedures.Ability to successfully conduct and manage a research study.Ability to provide effective leadership, motivate others and work as a member of a diverse team. Ability to mentor staff and to prepare training plans. Excellent verbal and written communication skills, organizational and time management skills with ability to work under pressure and meet deadlines. Ability to problem solve and work independently with a high degree of accuracy and attention to detail.Must be able to establish a good rapport with patients, investigators and sponsors.Competency in using Electronic Medical Record (EMR), Microsoft Office Suite, and other computerized programs
Physical Requirements and Working Conditions:Must be able to sit, stand, walk, lift, squat, bend, reach above shoulders and twist throughout shift.Must have functional sight and hearing.Ability to function in a latex environment.May be exposed to mechanical, electrical, chemical, and radiation hazards as well as blood and body fluids on a continuous basis; therefore, protective clothing (i.e., gown, mask, goggles, gloves, etc.) must be worn as necessary.Exposed to a normal office environment.Operates all equipment necessary to perform the job.Position may require travel among sites and therefore there is exposure to road and weather conditions.
This job description indicates the general nature and level of work expected of the incumbent. It is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities required of the incumbent. Incumbent may be required to perform other related duties.