We are seeking a Sr. Research Program Coordinator II (Sr. RPC II) who will work as part of the Division of Clinical Pharmacology Drug Development Unit (DDU) and support clinical studies sponsored by pharmaceutical companies, government agencies and Johns Hopkins investigators. The DDU conducts a variety of studies. This position will coordinate the HPTN network study, prepare and initiate an NIH Transgender study, as well as support ongoing departmental studies. Subject populations involved in the studies include healthy adults and various populations with diseases. The work on multiple complex clinical studies requires a high level of knowledge, coordination, and data abstraction. The Sr. RPC II must 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. Will interact with faculty, fellows, and staff of various divisions/departments of the Johns Hopkins School of Medicine and with external sponsors.

Specific Duties & Responsibilities

• Collaborate with investigators to define information and plans to accomplish the goals of the clinical trials.
• Oversee the administrative and scientific implementation of the assigned DDU research protocols
• Prepare essential documents, e.g. IRB submissions for protocol initiations, annual renewals, further study actions, adverse events, and progress reports according to IRB and sponsor requirements.
• Oversee subject recruitment in collaboration with the study team.
• Conduct screening interviews and administer screening questionnaires.
• Collect and organize data from patients, charts, electronic databases, clinical and research laboratories imaging services, and other sources.
• Assess eligibility of potential study subjects based on patient history and clinical laboratory results and study-specific inclusion and exclusion criteria.
• Enroll eligible subjects; track and document the status of subjects, track patient activity and complete all required information reports.
• Provide patient education to enhance subject safety and compliance with the study.
• Track and schedule patients and ensure compliance with protocol requirements.
• Coordinate and complete study visits according to study protocol including recording vital signs and performing phlebotomy as needed to obtain clinical samples
• Design and compile materials to aid physicians and other staff in complying with protocol requirements for subject visits and tests.
• Document adverse event and side effect data and confer with investigators regarding the reporting of events to oversight agencies.
• Prepare orders and perform protocol-specific in-service training for nursing staff and scheduled admissions in the inpatient Clinical Research Unit (CRU Osler 5).
• Design and maintain study-specific database and documents for research charts as needed
• Collect, compile, and maintain data in a research char for each patient from a variety of sources.
• Organize and enter subject and protocol data into DDU Volunteer, study roster, and other databases.
• Conduct data analysis and prepare results for presentations and publication.
• 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.
• Communicate with laboratories or investigators regarding laboratory findings.
• Prepare and participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.
• Complete and maintain up-to-date documentation of all required training

Additional Knowledge, Skills, and Abilities

• Knowledgeable of 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)
• 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.

• Bachelor's degree in related discipline.
  

• Five years related experience
  

• Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula

• Related Master's degree.
  

• Supervisory or lead responsibilities.
  

• Phlebotomy experience.
  

• Certification as a SOCRA or ACRP Clinical Research Coordinator preferred
  

• Familiarity with policies and guidelines of IRBs, DDU and clinical trial sponsors.

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-5pm 
Exempt Status: Exempt 
Location: School of Medicine Campus 
Department name: ​​​​​​​SOM DOM Clinical Pharmacology  
Personnel area: School of Medicine