Job Description

We are seeking a Sr. Research Coordinator II  who will work as part of the Division of Clinical Pharmacology Drug Development Unit and will support clinical studies sponsored by pharmaceutical companies, government agencies, and Johns Hopkins investigators. Subject populations involved in the studies include healthy adults and various populations with diseases.

The person in this position will

• Work on multiple complex clinical studies which require a high level of knowledge, coordination, and data abstraction
• Maintain detailed knowledge of all assigned protocols, adhere to all protocol requirements to ensure the validity of the clinical research data, and transmit/distribute protocol information as needed
• Interact with faculty, fellows, and staff of various divisions/departments of the Johns Hopkins School of Medicine.

Specific Duties & Responsibilities

• Assist investigators in defining information and plans required to accomplish the goals of the clinical trials.
• Prepare essential documents and maintain a binder and database of IRB submissions for protocol initiations, annual renewals, further study actions, adverse events, and progress reports according to IRB and sponsor requirements.
• Develop and maintain a protocol database and spreadsheets for tracking patient activity, financial management, and data analysis.
• Prepare and maintain study-specific database and documents for research charts e.g. source documents and case report forms when these are not supplied by a sponsor.
• Perform subject recruitment; develop advertising and recruitment materials, post flyers, and place advertisements in newspapers, websites, or other venues as determined by the study team.
• Complete and maintain up-to-date documentation of human subjects, research training required by the JHMIRB, DDU, and protocol Sponsors including but not limited to JHM Research Compliance, HIPAA, Bloodborne Pathogens, and CPR.
• Inform potential study subjects about research studies, procedures, and protocol requirements.
• Explain the informed consent process to subjects, obtain, and document subject informed consent.
• Conduct screening interviews and administer screening questionnaires.
• Collect study-required data from patients, charts, electronic databases, clinical and research laboratories, imaging services, and other sources.
• Assess eligibility of potential study subjects comparing patient history and clinical laboratory results with study-specific inclusion and exclusion criteria.
• Enroll eligible subjects into studies and provide eligibility source documentation for all patients enrolled in the study.
• Maintain study subject rosters to track and document the status of subjects and complete screening, enrollment, completion, dropout, and termination information reports.
• Provide patient education as needed to enhance subject safety and compliance with the study.
• Prepare orders and perform protocol-specific in-service training for nursing staff and scheduled admissions in the inpatient Clinical Research Unit (CRU Osler 5).
• Order and inventory clinical supplies necessary for the performance of studies.
• Assemble PK kits and admission documentation to be supplied for inpatient CRU study visits.
• Schedule subjects for admissions, appointments, tests, and follow-up visits at the appropriate time to ensure completion of protocol requirements.
• Coordinate and complete subject study visits according to study protocol including vital signs, ECGs, phlebotomy, obtaining clinical samples, and performing health assessments.
• Design and compile materials that aid physicians and other staff in complying with protocol requirements for these visits and tests.
• Collect, compile, and maintain data in a research chart for each patient from a variety of sources.
• Organize and enter subject and protocol data into DDU Volunteer, study roster, and other databases.
• Communicate with laboratories or investigators regarding laboratory findings.
• Record adverse event and side effect data and confer with investigators regarding the reporting of events to oversight agencies.
• Monitor to confirm the accuracy and timeliness of protocol procedures and data entries so that data information may be used for presentations and publication.
• Prepare for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.

• Bachelor's Degree in a related discipline. Related Master's preferred.
• Five years related experience.
• Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.

• Demonstrated supervisory or lead responsibilities.
• Proven experience and successful work history in a comparable clinical trials research environment.
• Knowledgeable of and compliant with the Code of Federal Regulations Title 21-Good Clinical Practice Parts,11, 50, 54, 56, and 312; with the International Conference on Harmonization Good Clinical Practice Guideline (E6); and with the policies and guidelines of the Johns Hopkins Medicine IRB, and SOPs of the DDU and clinical trial sponsors.
• Demonstrated organizational and time management skills with a high degree of attention to detail.
• Ability to manage multiple and competing priorities.
• Proficiency in working with computers and various software applications, especially Microsoft Excel and Microsoft Word, the World Wide Web, and electronic mail.
• Phlebotomy experience.
• Certification as a SOCRA or ACRP Clinical Research Coordinator preferred.

Physical Requirements

• Work produced is subject to precise measures of quantity and quality.
• Near vision to see objects clearly within 20 inches.
• Sharp focus to adjust vision when doing close work that changes in distance from eyes.
• Full spectrum vision to identify and distinguish color.
• Finger dexterity required to manipulate objects with fingers rather than with whole hand(s) or arm(s), for example, using a keyboard.
• Handling by seizing, holding, grasping, turning, or otherwise working with the hand or hands, but without finger dexterity.
• Occasionally lifting and carrying objects weighing 20 lbs. or less.
• Occasionally pushing or pulling objects weighing 20 lbs. or less.
• Ability to move about without restriction.

Classified Title: Sr. Research Program Coordinator II 
Role/Level/Range: ACRP/04/MC  
Starting Salary Range: $48,000 - $84,100 Annually ($66,000 targeted; Commensurate with experience) 
Employee group: Full Time 
Schedule: Monday-Friday; 8:30am-5:00pm 
Exempt Status: Exempt 
Location: School of Medicine Campus 
Department name: ​​​​​​​SOM DOM Clinical Pharmacology 
Personnel area: School of Medicine 

About Johns Hopkins University

Johns Hopkins University remains committed to its founding principle, that education for all students should be grounded in exploration and discovery. Hopkins students are challenged not just to learn but also to advance learning itself. Critical thinking, problem solving, creativity, and entrepreneurship are all encouraged and nourished in this unique educational environment. After more than 130 years, Johns Hopkins remains a world leader in both teaching and research. Faculty members and their research colleagues at the university's Applied Physics Laboratory have each year since 1979 won Johns Hopkins more federal research and development funding than any other university. The university has nine academic divisions and campuses throughout the Baltimore-Washington area. The Krieger School of Arts and Sciences, the Whiting School of Engineering, the School of Education and the Carey Business School are based at the Homewood campus in northern Baltimore. The schools of Medicine, Public Health, and Nursing share a campus in east Baltimore with The Johns Hopkins Hospital. The Peabody Institute, a leading professional school of music, is located on Mount Vernon Place in downtown Bal ... timore. The Paul H. Nitze School of Advanced International Studies is located in Washington's Dupont Circle area.

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