The Johns Hopkins University Department of Genetics is seeking a Research Program Coordinator who will be responsible for the administrative and implementation of multiple complex clinical research studies in the clinical trials unit. For clinical trials, this includes preparing and managing IRB applications, ensuring compliance with all regulatory requirements, and preparing amendments to the protocols with the IRB. Responsible for developing the clinical trial budget with representatives from the CRO, sponsor and JHU Office of Research Administration; interacting directly with research subjects to schedule visits and carry out study activities. The coordinator will enter study data and meet with study monitors. For investigator-initiated trials, this includes similar IRB, budget and contracting responsibilities plus data entry, management and reporting and other clinical research activities as required for study execution.

Specific Duties and Responsibilities

• Assist Principal Investigator (PI) in managing a $1M+ clinical research study including site initiation, ongoing site visits, recruitment, training, education, and data management.
• Responsible for the accurate collection and record maintenance of research data, control data quality and maintenance of databases and IRB documents. Extracting clinical data for the population into multiple investigator-initiated databases (i.e. dysplasias, cleft, craniofacial, HPP) on a weekly basis. Organize, review and edit raw data, with study’s Principal Investigator to make appropriate data revisions. Work with biostatistician for data transfer.
• Developing clinical trial budgets for contract submission and interacting with the Office of Research Administration to execute the same.
• Tracking all clinical trial expenses over study execution and reporting these data to the study sponsor for quarterly invoicing.
• Manage complex databases for research studies such as REDCap, Access, STATA and Qaltrics surveys.
• Monitor accuracy of study personnel listed on each of the IRB protocols.
• Ensure all Human Subjects Research Training is up to date for all personnel, collaborators, residents and staff listed on the protocols.
• Participate in development, testing and evaluation of manuals, questionnaires, and coding structures, for the efficient collection of data.
• Assist with writing manuscripts and abstracts for medical journals and meetings, presentation of projects/data at medical meetings, protocol development of sub-studies.
• Conduct literature searches to provide background information.
• Abstract and index information based on knowledge of subject matter.
• Perform regulatory audits for all clinical trials.
• Update continuing review and study progress to PI, Research Team, collaborators, and department administration.
• Collaborate with the PI and study team to ensure smooth and efficient implementation and execution of developed research protocols.
• Coordinate patient visits (i.e. meeting and transportation of patients), verify patient eligibility, consent research participants, and maintain research integrity.
• Communicate with multiple research departments to facilitate study logistics and completion.
• Maintains good working knowledge of all assigned protocols, maintains regulatory documentation for each assigned protocol, reviews data accuracy with PI regularly and updates on overall progress.
• Coordinate serious adverse events reporting with clinicians and investigators to ensure prompt reporting to Johns Hopkins Medicine Institutional Review Board (JHMIRB) and study sponsors.
• Other duties as needed and assigned by the PI as related to clinical research in the division.

Physical Requirements

• Sitting for extended periods of time.
• Reaching by extending hand(s) or arm(s) in any direction.
• Finger dexterity to manipulate objects with fingers rather than with whole hand or arm, for example, using a keyboard.
• Communication skills using the spoken word.
• Ability to see and hear within normal parameters and move about workspace.

Knowledge, Skills, and Abilities

• Ability to work in MS Excel, MS Access, and MS Word required.
• Attention to detail required, as well as the ability to work independently.

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

• Clinical trial and/or research experience, including IRB application and maintenance process.

Classified Title: Research Program Coordinator 
Role/Level/Range: ACRO40/E/03/CD  
Starting Salary Range: $17.20 - $30.30 HRLY ($49,400 targeted; Commensurate with experience) 
Employee group: Full Time 
Schedule: M-F, 8:30 to 5pm 
Exempt Status: Non-Exempt 
Location: School of Medicine Campus 
Department name: ​​​​​​​SOM Genetics Greenberg Ctr Skel Dysplasi  
Personnel area: School of Medicine