Sr. Clinical Research Coordinator (Neurology)

Johns Hopkins University; Baltimore (MD); On-site; USD 42,000 - 74,000; Full time

Job summary

Johns Hopkins University is seeking a Sr. Clinical Research Coordinator to oversee day-to-day activities of interventional studies investigating ALS. You will lead regulatory and data processes, develop recruitment strategies, and collaborate with sponsors and investigators to ensure protocol adherence.

The role requires preparing SOPs, consent forms, and IRB materials, while managing budgets and data systems. This is a full-time position in the School of Medicine Campus with exempt status.

Qualifications

• Bachelor's degree in a related field.
• Three years of related experience required; additional education may substitute for experience.
• Master's degree in a related field preferred.

Responsibilities

• Assist PI and senior staff to ensure feasibility of protocol/design.
• Develop SOPs and data collection forms from protocols.
• Create consent forms for clinical trials.
• Prepare IRB submissions and regulatory documents.
• Collaborate with sponsors to assess resources and costs.
• Ensure compliance with protocols and regulations.
• Contribute to study budget development.
• Develop participant recruitment strategies and data capture systems.
• Setup data collection systems and ensure data quality.
• Audit study data and participate in meetings to propose protocol improvements.
• Conduct literature searches and index information for studies.

Skills

Budget Management

Clinical Research Recruitment

Clinical Study Design

Clinical Trial Management System

Data Management

Data Collection

Good Clinical Practices

Interpersonal Skills

Project Management

Regulatory Compliance

Report Writing

Education

Bachelor's Degree in a related field

Three years of related experience

Master's Degree preferred

Job description

Johns Hopkins, founded in 1876, is America's first research university and home to nine world-class academic divisions working together as one university.

The Department of Neurology is seeking a Sr. Clinical Research Coordinator to assist and support clinical research studies investigating Amyotrophic Lateral Sclerosis. Researchers at Johns Hopkins University conduct clinical trials and clinical studies to discover new ways to prevent and treat diseases and other health problems. The Sr. Clinical Research Coordinator oversees the day-to-day activities of multiple complex interventional studies. Assists in goal setting and creating implementation plans. Contributes to budget formulation, communications, and data systems.

Specific Duties & Responsibilities

• Assist Principal Investigator or more senior research staff to ensure operational feasibility of proposed protocol/study design.
• Develop standard operating procedures and data collection forms from protocol(s).
• Develop consent form(s) for clinical trials based on protocol(s).
• Prepare materials for submission to IRB.
• Contribute to work with commercial and/or government agency sponsors and recommend which group can commit to considering patient population, available resources, and cost of providing services.
• Ensure compliance with all protocols, procedures, and applicable regulations.
• Participate in developing the study budget.
• Develop and oversee the implementation of recruitment strategy for participants for one or more assigned studies.
• Set up a data collection system and ensure the validity of study data.
• Organize and quality control study data
• Perform self-audits and/or audit other sites.
• Participate in study meetings and provide status updates and recommend changes to protocol operations based on results and goals.
• Conduct literature searches to provide background information.
• Abstract and index information based on knowledge of subject matter.
• Other duties as assigned.

In addition to the duties above:

• Independently execute all protocol-related activities, including study visit scheduling, pending study drug orders to providers, procuring study drug from Investigational Drug Service, patient assessments, sample processing and shipping and data collection
• Manage all regulatory documentation
• Enter study data into Electronic Data Capture Systems.

Minimum Qualifications

• Bachelor's Degree in a related field.
• Three years of related experience.
• Additional education may substitute for required experience and additional related experience may substitute for required education beyond a high school diploma/graduation equivalent, to the extent permitted by the JHU equivalency formula.

Preferred Qualifications

• Master's Degree in a related field.

The core technical skills listed are most essential; additional technical skills may be required based on specific division or department needs.

Technical Skills & Expected Level of Proficiency

• Budget Management - Developing
• Clinical Research Participant Recruitment - Developing
• Clinical Study Design - Developing
• Clinical Trial Management System - Developing
• Data Management and Analysis - Developing
• Data Collection and Reporting - Developing
• Good Clinical Practices - Developing
• Interpersonal Skills - Developing
• Project Management - Developing
• Regulatory Compliance - Developing
• Report Writing - Developing

Classified Title: Sr. Clinical Research Coordinator
Role/Level/Range: ACRP/03/MB
Starting Salary Range: $42,330 - $74,110 Annually ($58,220Targeted; Commensurate w/exp.)
Employee group: Full Time
Schedule: M-F 8:30 am - 5:00 pm
FLSA Status: Exempt
Location: School of Medicine Campus
Department name: SOM Neuro Neuromuscular
Personnel area: School of Medicine

The successful candidate(s) for this position will be subject to a pre-employment background check.

The following additional provisions may apply depending on which campus you will work. Your recruiter will advise accordingly.

During the Influenza ("the flu") season, as a condition of employment, The Johns Hopkins Institutions require all employees who provide ongoing services to patients or work in patient care or clinical care areas to have an annual influenza vaccination or possess an approved medical or religious exception. Failure to meet this requirement may result in termination of employment.

The pre-employment physical for positions in clinical areas, laboratories, working with research subjects, or involving community contact requires documentation of immune status against Rubella (German measles), Rubeola (Measles), Mumps, Varicella (chickenpox), Hepatitis B and documentation of having received the Tdap (Tetanus, diphtheria, pertussis) vaccination. This may include documentation of having two (2) MMR vaccines; two (2) Varicella vaccines; or antibody status to these diseases from laboratory testing. Blood tests for immunities to these diseases are ordinarily included in the pre-employment physical exam except for those employees who provide results of blood tests or immunization documentation from their own health care providers. Any vaccinations required for these diseases will be given at no cost in our Occupational Health office.

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