Clinical Research Coordinator I

The Clinical Research Coordinator will be assigned to pharmaceutical studies, device clinical trials, and/or investigator-initiated research projects. This position works under the supervision of Principal Investigator(s) and Director, Clinical Research Operations whose research activities are conducted under good clinical practice (GCP) guidelines. This is an onsite position. Work hours will need to be flexible to meet individual project needs. Evening, weekend, and overnight hours may be required. Attendance at departmental and weekly general staff meetings is expected. Responsibilities Responsible for the integrity and overall quality of assigned clinical research trials Responsible for organizing and leading assigned studies Communicates with the sponsor’s site monitors, Clinical Research Associates (CRAs), and local and/or central Institutional Review Boards (IRBs) Prepares, schedules, and leads and/or participates in study visits with monitors, sponsors, and auditors Follows GCP regulations, state and local laws, and study protocols Participates in the Informed Consent process, potentially including drafting, amending, and conducting Informed Consent visits with study subjects Reviews protocols to ensure each study fits with the SDRI mission statement and that we can actively recruit the required subject population and conduct the study successfully Create and maintain source documents Completes Case Report Forms (CRFs) for assigned studies and enters electronic data as required by the study CRFs will be completed and up-to-date prior to site monitor visits Changes or corrections noted by the monitors will be completed before the next scheduled monitor visit date or as specified by the sponsor’s deadline Completes and submits Adverse Event (AE) forms per protocol and regulatory guidelines and Serious Adverse Events (SAE) forms to the sponsor and the IRB within 24 hours of SAE occurrence Supervises recruitment process for assigned studies, screens potential subjects, and conducts subject visits Establishes and maintains relationships with study subjects and participates in subject education regarding the clinical trial process, and provides specific trial information to each subject/volunteer Completes regulatory documents for assigned studies, including submission for IRB initial approval and applicable renewals Attends Investigator Meetings as assigned Maintains drug and device accountability and dispensing logs for assigned studies Clinical duties include, but are not limited to: Completion of comprehensive medical history for study subjects Measure vital signs, weight, and height of study subjects per protocol and reports any abnormal results to the Principal Investigator or sub-Investigator Phlebotomy and blood sample processing according to universal bloodborne pathogen precautions Recording 12-lead ECGs per protocol Providing ongoing patient education Ordering outside laboratory tests and/or procedures on an as-needed basis Laboratory duties include: Centrifugation of blood samples Processing and packaging of body fluid samples (including but not limited to blood, urine, and saliva) Proper sample storage Proper shipment of samples, including contacting the appropriate courier Maintains cleanliness and order in all of the designated areas during studies. Complies with Safety Committee policies and recommendations Assists with medical writing as appropriate and assigned, including protocols, scientific papers, and grant writing Other duties as assigned by superiors Qualifications Basic knowledge of accepted clinical research practices, including universal precautions, human subjects research protocols, and HIPAA requirements Knowledge of drug development process, ICH guidelines, and FDA CFRs Ability to lead studies independently Ability to handle 3 or more studies simultaneously Ability to work independently and with careful attention to detail as well as in collaboration with other staff members Basic knowledge of office practices and office equipment Basic knowledge of computer systems for word processing, electronic mail, data entry, and electronic data transfer Basic typing skills Excellent multi-tasking, prioritization, communication, and organizational skills and ability to work under stress Ability to transfer and record data accurately, in the required format, and in a timely manner Must be able to establish rapport and communicate with subjects of diverse cultural and educational backgrounds Interpersonal skills, public speaking, and report writing abilities Ability to understand and carry out instructions in written, oral, or diagram form Proven ability to deal with problems with several variables and ability to prioritize tasks and activities in a manner consistent with direction from supervisor Ability to think and reason critically Education and Experience Experience working in a medical setting At least two years of experience working in clinical research High school diploma and Bachelor’s degree or equivalent experience Scientific or nursing education desirable Phlebotomy skills desired ACRP CCRC certification highly desirable Language Skills The ability to read, write and speak English clearly is required. The ability to interpret documents such as safety rules, SOPs, and procedures is critical and an understanding of and ability to communicate in scientific language is desired. Spanish proficiency and/or fluency desired. Physical Demands The incumbent is regularly required to sit, talk, hear, and climb stairs. The incumbent frequently is required to use hands to finger, handle or feel equipment, paper, or files. The incumbent is required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 10-20 pounds. Specific vision abilities required by this job include close vision. This position requires manual dexterity, skill level and adequate vision to record data onto data sheets and adequate hearing and verbal communication skills to converse with study subjects. Standing for extended periods of time as well as light lifting is necessary. The incumbent must be in sufficient overall health to report for work consistently and reliably and work through a standard day with appropriate breaks. Work Environment The work environment would be generally described as an office setting with clinical facilities adjacent to the primary work area and laboratory facilities on a different floor. The ability to move within all three of these areas may be required in the execution of the employee’s functional activities. The noise level in the work environment is usually moderate and the illumination of the work area is primarily with fluorescent artificial lighting. This position is associated with exposure to biohazardous materials and communicable disease requiring the use of universal precautions at all times as well as other conditions common to a medical clinic and research facility. This job description is intended to describe the general requirements of the performance of the job. It is not a complete list of duties, responsibilities or requirements. Other duties not listed here may be assigned as needed. #J-18808-Ljbffr