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The Department of Neurology is seeking a sIRB Research Navigator for the BIOS Clinical Trials Coordinating Center’s (CTCC) who will deliver and organize work plans with 20+ collaborating clinical sites across the country. In this position, there are opportunities to work with a high functioning, cutting edge team that will study, understand and improve multi-site translational research. This position requires a person with clinical trial design expertise and regulatory experience in working with IRBs and master/standard agreements. Autonomy, creativity, and critical thinking skills are strongly encouraged and welcomed.

The sIRB Research Navigator will work with site investigators to help them meet targets and milestones (ensure timely and accurate submission to IRBs, sponsors and master agreements). The sIRB Research Navigator will execute project management processes and methodologies to ensure projects are delivered on-time and within the budget, adhere to high quality standards, and benefit the investigative teams by ensuring smooth implementation of new trials from conception through study activation. The successful candidate will be expected to stay current with a constantly changing clinical research technology and embrace the adoption of innovations to modernize, disseminate, renovate and remodel.

This individual will serve as a knowledgeable liaison between BIOS CTCC leadership and the CTSA communities and other consortiums.

Specific Duties & Responsibilities

• Prepare regulatory documents for single (sIRB) review for studies seeking sIRB coordination resources.

• Work with participating sites to compile local context information for initial review, continuing review, protocol event reports and applicable changes in research to facilitate submission to the JHM sIRB.

• Assist the JHM IRB in contacting participating sites to address inquiries related to IRB review.

• Train participating site leads on sIRB expectations/procedures.

• Coordinate with JHM sIRB leads to enhance sIRB processes for BIOS-supported studies.

• Develop work plans to achieve assigned project goals and organize all activities in support of project goals.

• Complete and maintain professional documentation for projects and deliverables.

• Obtain all required documents for new grant and protocol submissions.

• Track each protocol through the IRB/subcommittee approval process, evaluate for recurrent problems, develop and implement systems to decrease delays in the approval process.

• Draft consents.

• Use professional judgment in handling information based on the situation and be sensitive to individual and organizational concerns.

• Ensure smooth implementation of new trials from conception through study activation.

• Work closely with the study teams and cores to ensure all documents are complete prior to study/trial activation.

• Develop SOPs as needed.

• Collaborate with other institutions.

• Serve as liaison and facilitate meetings between project stakeholders and BIOS CTCC leadership and complete and maintain professional documentation for projects and deliverables, develop SOPs as needed, and assist coordinating center personnel in the auditing and monitoring of studies.

• Assemble project plans, team and work assignments, directing and monitoring work efforts on a daily basis, identifying resource needs, performing quality review, and escalating functional, quality and timeline issues appropriately.

• Manage BIOS CTCC investigator relationships.

• Handle information and be sensitive to project team, individual and all levels of organizational concerns; make use of data, statistical and quantitative analysis, explanatory and predictive modeling and fact-based management to drive decision making; and help investigators develop new insights and understanding of performance-based data.

• Build and maintain strong, trusting relationships.

• Present to investigative teams, end-users (faculty and staff), and subject-matter experts and must possess excellent negotiation, facilitation, consensus-building, and diplomacy skills and exhibit a strong helpline orientation.

• Oversee and coordinate the work of teams in other institutions.

Additional Knowledge, Skills & Abilities

• Advanced knowledge and experience with GCP/ICH and local regulations.

• Proficient in web-based data collection applications.

• Ability to prioritize own work and work of others as needed.

• Strong organizational skills, analytical and problem-solving abilities, and attention to detail.

• Ability to work with flexibility on several tasks simultaneously and to meet various concurrent deadlines.

• Proficient in Microsoft Office Suite: Outlook, Word, Excel, PowerPoint, and Teams.

• Proficient with SharePoint, collaborating and co-authoring of documents.

• Ability to learn new software programs such as electronic data capture software, eIRB, Redcap, and project management software, which will be taught on the job.

• Ability to make independent judgments, act on decisions on a daily basis, work for long periods of time without direction and work with flexibility on several tasks simultaneously and to meet various concurrent deadlines.

• Strong organizational skills, analytical and problem-solving abilities, and attention to detail.

• Ability to coordinate projects independently and work constructively as part of a team.

• Ability to maintain confidentiality.

• Strong interpersonal and communication skills, both oral and written.

Minimum Qualifications

• Bachelor's Degree with course work in science or health care administration required.

• Minimum of five year's experience in clinical trials/ medical research comparable to overseeing the administrative and scientific implementation of research protocol(s) for complex and/or multiple research studies.

• Clinical trial design expertise and regulatory experience in working with IRBs and master/standard agreements.

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

Preferred Qualifications

• Master's Degree in related discipline.

• Certification as a Clinical Research Professional.

• Experience in clinical research at an academic, government, or pharmaceutical industry environment preferred.

Classified Title: Research Navigator

Job Posting Title (Working Title): sIRB Research Navigator

Role/Level/Range: ACRP/04/ME

Starting Salary Range: $64,000 - $112,200 Annually (Commensurate with experience)

Employee group: Full Time

Schedule: M-F 8:30 am - 5:00 pm

Exempt Status: Exempt

Location: Remote

Department name: SOM Neuro BIOS

Personnel area: School of Medicine

Equal Opportunity Employer:

Johns Hopkins University is an equal opportunity employer and does not discriminate on the basis of race, color, gender, religion, age, sexual orientation, national or ethnic origin, disability, marital status, veteran status, or any other occupationally irrelevant criteria. The university promotes affirmative action for minorities, women, disabled persons, and veterans.