Clinical Research Site Manager (Neurology)
The Johns Hopkins University · Baltimore, MD · 1 mo ago
Analyst$57k–$100k/yrFull-time
We need to output HTML fragment with sections: headings for sections like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections that have real specific content. We must not repeat job title as heading. Must not include Job ID etc. Must preserve all substantive info. Remove boilerplate.
We need to parse the posting.
Key info:
- Department of Neurology seeking Clinical Research Site Manager for BIOS Division in School of Medicine.
- Role description: oversees site-level execution of large multicenter clinical trials by leading site startup, driving enrollment performance, managing investigator relationships, ensuring consistent protocol implementation across national network of collaborating clinical sites.
- Requires high degree of independence, operational leadership, performance-driven site management.
- Specific Duties & Responsibilities: long list.
- Then there are subheadings: MultiSite StartUp & Activation Leadership, Enrollment Performance Management & Remediation, Investigator & Site Relationship Management, Operational Oversight of Trial Execution, Audit, Quality Review & Continuous Improvement.
- Minimum Qualifications: Bachelor’s Degree in a related field. Five years of related experience delivering effective clinical research management solutions. 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: Prior clinical research experience.
- Technical Skills & Expected Level Of Proficiency: list of skills with Intermediate.
- The core technical skills listed are most essential; additional technical skills may be required based on specific division or department needs.
- Classified Title: Clinical Research Site Manager Role/Level/Range: ACRP/04/MD Starting Salary Range: $57,195 - $100,040 Annually ($78,620 targeted; Commensurate w/exp.) Employee group: Full Time Schedule: M-F 8:30 am - 5:00 pm FLSA Status: Exempt Location: Remote Department name: SOM Neuro BIOS Personnel area: School of Medicine
We need to include sections only if they have real specific content.
We have:
- About the role: we can include a paragraph summarizing the role description (first paragraph). That is substantive.
- Responsibilities: we have a long list of duties. Should be under
for sections like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections that have real specific content. We must not repeat job title as heading. Must not include Job ID etc. Must preserve all substantive info. Remove boilerplate.
We need to parse the posting.
Key info:
- Department of Neurology seeking Clinical Research Site Manager for BIOS Division in School of Medicine.
- Role description: oversees site-level execution of large multicenter clinical trials by leading site startup, driving enrollment performance, managing investigator relationships, ensuring consistent protocol implementation across national network of collaborating clinical sites.
- Requires high degree of independence, operational leadership, performance-driven site management.
- Specific Duties & Responsibilities: long list.
- Then there are subheadings: MultiSite StartUp & Activation Leadership, Enrollment Performance Management & Remediation, Investigator & Site Relationship Management, Operational Oversight of Trial Execution, Audit, Quality Review & Continuous Improvement.
- Minimum Qualifications: Bachelor’s Degree in a related field. Five years of related experience delivering effective clinical research management solutions. 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: Prior clinical research experience.
- Technical Skills & Expected Level Of Proficiency: list of skills with Intermediate.
- The core technical skills listed are most essential; additional technical skills may be required based on specific division or department needs.
- Classified Title: Clinical Research Site Manager Role/Level/Range: ACRP/04/MD Starting Salary Range: $57,195 - $100,040 Annually ($78,620 targeted; Commensurate w/exp.) Employee group: Full Time Schedule: M-F 8:30 am - 5:00 pm FLSA Status: Exempt Location: Remote Department name: SOM Neuro BIOS Personnel area: School of Medicine
We need to include sections only if they have real specific content.
We have:
- About the role: we can include a paragraph summarizing the role description (first paragraph). That is substantive.
- Responsibilities: we have a long list of duties. Should be under Responsibilities
with - items.
- Requirements: Minimum Qualifications (Bachelor's degree, 5 years experience, etc.) Could be under Requirements.
- Qualifications: Preferred Qualifications (Prior clinical research experience). Could be under Qualifications.
- Skills: Technical Skills list. Could be under Skills.
- Pay: Starting Salary Range: $57,195 - $100,040 Annually ($78,620 targeted; Commensurate w/exp.) This is specific. So we can include Pay section.
- Schedule: Employee group: Full Time Schedule: M-F 8:30 am - 5:00 pm. So we can include Schedule.
- Benefits: Not mentioned. So omit Benefits.
- Also location: Remote. Could be included maybe under About the role or a separate section? Not required headings list includes Benefits, Pay, Schedule. Location not in list; we could incorporate location into About the role paragraph or maybe a separate
but not a heading. Since we must not invent sections not in list, but we can add other headings? The instruction: "use
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule)." It says e.g., implying those are examples but we could use others? Safer to stick to those headings only. So we should not add a heading for Location. We can include location info in a paragraph under About the role or maybe under Responsibilities? Probably About the role.
We must not repeat job title as heading. So no Clinical Research Site Manager
.
We must not put Job ID/requisition numbers as headings; none present.
We must remove boilerplate: cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, application instructions. None present.
We must preserve ALL substantive information; do not invent or summarize away detail. So we need to keep all details from the posting. That includes many duty bullet points. We must not omit any duty. Must keep all details.
We need to convert duties into list items. Ensure we capture each bullet.
Let's extract duties from the text:
Specific Duties & Responsibilities (the paragraph after that heading). Then list:
- Oversee and coordinate the work of teams in other institutions.
- Establish early lines of communication with the clinical teams as they are identified, selected, and prepared for activation.
- Propel accelerated timelines during the trial start-up cycle and during subject accrual, assuring that monthly enrollment goals are met each month across all clinical sites.
- Assist with site feasibility evaluations, detailing the availability of critical local resources necessary to be successful at activating trials and enrollment and protocol performance once a trial begins.
- Assist sites in central IRB onboarding, ensure timely and accurate submission to IRBs, sponsors, and master agreements, local IRB/ethics committee review/approvals, and assist with the collection of all necessary regulatory documents needed before site activation for study subject enrollment.
- Oversee site compliance with investigational products, reporting or safety events and contracting.
- During trial implementation, oversee site performance, assist with subject eligibility and randomization, identify local recruitment problems, personalize remediation programs with site teams, and ensure that site investigators quickly implement local solutions to keep the recruitment goal on track for trial completion.
- Conduct weekly (or more frequent) teleconferences and manage monthly training broadcasts with the clinical teams and individually mentor new coordinators and investigators.
- Keep enrollments on track and clinical teams on schedule with established performance expectations.
- Provide support to quality assurance monitors in all facets of work related to communications with, and management of, the enrolling center clinical teams.
- Manage site investigator relationships and execute site start-up and performance plans, assign tasks and deadlines to site clinical teams, direct and monitor clinical site work efforts daily, identify resource needs, perform quality reviews, and escalate functional, quality and timeline issues appropriately.
- Execute lean management processes and methodologies to ensure sites deliver on-time and within the budget, adhere to high-quality standards, and benefit the investigative effort by ensuring smooth implementation of trial policies and goals from site launch through study activation and completion of the trial at the local levels.
- Perform self-audits and audit performance of clinical sites; recommend changes to protocol operations based on audit results and revised goals.
- Track proposals and other documentation through signature/approval processes and through collaboration with contracts personnel and IRB Navigators.
- Use professional judgment in handling information and be sensitive to the project team, individual, and all levels of organizational concerns
- Use data, statistical and quantitative analysis, explanatory and predictive modeling, and fact-based management to drive decision making
- Help investigators develop new insights and understanding of performance-based data.
- Serve as liaison and facilitate meetings between project stakeholders and leadership
- Complete and maintain professional documentation for projects and deliverables
- Develop SOPs and assist in the auditing and monitoring of study sites.
- Build and maintain strong, trusting relationships.
- Remain current with a constantly changing clinical research technology and embrace the adoption of innovations to modernize, disseminate, renovate and remodel.
- Serve as a knowledgeable liaison between leadership and the research communities.
- Other duties as assigned.
Then after "In addition to the duties above" there are subheadings with more detailed duties:
MultiSite StartUp & Activation Leadership
- Lead site startup activities across numerous external clinical sites, including feasibility assessments, resource readiness evaluations, activation timelines, and onboarding to centralized IRB and master agreement processes.
Enrollment Performance Management & Remediation
- Actively track sitelevel enrollment metrics, identify underperforming sites, and design customized remediation strategies to address recruitment barriers and keep trials on pace for completion.
Investigator & Site Relationship Management
- Serve as the primary operational liaison for site investigators and coordinators, building trust, setting expectations, assigning deliverables, and holding sites accountable for performance, quality, and timelines.
Operational Oversight of Trial Execution
- Direct and monitor daily site activities related to subject eligibility, randomization, protocol adherence, safety reporting, and investigational product compliance, escalating risks and issues as necessary.
Audit, Quality Review & Continuous Improvement
- Oversee site performance reviews; recommend operational or protocollevel improvements based on performance data and evolving trial needs.
We need to include all these as list items under Responsibilities. Could also separate into subheadings but not required. We'll just list all duties as
- items.
Now Minimum Qualifications:
- Bachelor’s Degree in a related field.
- Five years of related experience delivering effective clinical research management solutions.
- 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:
- Prior clinical research experience.
Technical Skills & Expected Level Of Proficiency list:
- Analytical Skills - Intermediate
- Attention to Detail - Intermediate
- Clinical Study Design - Intermediate
- Clinical Trials - Intermediate
- Forecasting - Intermediate
- Interpersonal Skills - Intermediate
- Oral and Written Communications - Intermediate
- Process Improvement - Intermediate
- Project Management - Intermediate
- Regulatory Compliance - Intermediate
Also note: "The core technical skills listed are most essential; additional technical skills may be required based on specific division or department needs." This is substantive; we should include as a sentence maybe in Skills section.
Pay:
- Starting Salary Range: $57,195 - $100,040 Annually ($78,620 targeted; Commensurate w/exp.)
Schedule:
- Employee group: Full Time Schedule: M-F 8:30 am - 5:00 pm
- FLSA Status: Exempt
- Location: Remote
- Department name: SOM Neuro BIOS
- Personnel area: School of Medicine
We may include location and department info in About the role paragraph.
We must not include Benefits section because not mentioned.
Now craft HTML.
Structure:
About the role
... paragraph containing role overview, location, department, etc.
Responsibilities
- ... each duty
Requirements
- ... minimum qualifications
Qualifications
- ... preferred qualifications
Skills
- ... technical skills
The core technical skills listed are most essential; additional technical skills may be required based on specific division or department needs.
Pay
Starting Salary Range: $57,195 - $100,040 Annually ($78,620 targeted; Commensurate w/exp.)
Schedule
Employee group: Full Time; Schedule: M-F 8:30 am - 5:00 pm; FLSA Status: Exempt; Location: Remote; Department: SOM Neuro BIOS; Personnel area: School of Medicine
We need to ensure we don't repeat job title as heading. Good.
Check for any duplicated lines: we must avoid duplication. Ensure each duty appears once.
Now produce HTML fragment only.
Let's craft the About the role paragraph: combine the initial description: "The Department of Neurology is seeking a Clinical Research Site Manager for the BIOS Division in the School of Medicine. The Clinical Research Site Manager oversees site-level execution of large, multicenter clinical trials by leading site startup, driving enrollment performance, managing investigator relationships, and ensuring consistent protocol implementation across a national network of collaborating clinical sites. The role requires a high degree of independence, operational leadership, and performance-driven site management." Also include location remote and department maybe.
We'll include location remote and department name SOM Neuro BIOS and Personnel area
but not a heading. Since we must not invent sections not in list, but we can add other headings? The instruction: "use
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule)." It says e.g., implying those are examples but we could use others? Safer to stick to those headings only. So we should not add a heading for Location. We can include location info in a paragraph under About the role or maybe under Responsibilities? Probably About the role.
We must not repeat job title as heading. So no Clinical Research Site Manager
.
We must not put Job ID/requisition numbers as headings; none present.
We must remove boilerplate: cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, application instructions. None present.
We must preserve ALL substantive information; do not invent or summarize away detail. So we need to keep all details from the posting. That includes many duty bullet points. We must not omit any duty. Must keep all details.
We need to convert duties into list items. Ensure we capture each bullet.
Let's extract duties from the text:
Specific Duties & Responsibilities (the paragraph after that heading). Then list:
- Oversee and coordinate the work of teams in other institutions.
- Establish early lines of communication with the clinical teams as they are identified, selected, and prepared for activation.
- Propel accelerated timelines during the trial start-up cycle and during subject accrual, assuring that monthly enrollment goals are met each month across all clinical sites.
- Assist with site feasibility evaluations, detailing the availability of critical local resources necessary to be successful at activating trials and enrollment and protocol performance once a trial begins.
- Assist sites in central IRB onboarding, ensure timely and accurate submission to IRBs, sponsors, and master agreements, local IRB/ethics committee review/approvals, and assist with the collection of all necessary regulatory documents needed before site activation for study subject enrollment.
- Oversee site compliance with investigational products, reporting or safety events and contracting.
- During trial implementation, oversee site performance, assist with subject eligibility and randomization, identify local recruitment problems, personalize remediation programs with site teams, and ensure that site investigators quickly implement local solutions to keep the recruitment goal on track for trial completion.
- Conduct weekly (or more frequent) teleconferences and manage monthly training broadcasts with the clinical teams and individually mentor new coordinators and investigators.
- Keep enrollments on track and clinical teams on schedule with established performance expectations.
- Provide support to quality assurance monitors in all facets of work related to communications with, and management of, the enrolling center clinical teams.
- Manage site investigator relationships and execute site start-up and performance plans, assign tasks and deadlines to site clinical teams, direct and monitor clinical site work efforts daily, identify resource needs, perform quality reviews, and escalate functional, quality and timeline issues appropriately.
- Execute lean management processes and methodologies to ensure sites deliver on-time and within the budget, adhere to high-quality standards, and benefit the investigative effort by ensuring smooth implementation of trial policies and goals from site launch through study activation and completion of the trial at the local levels.
- Perform self-audits and audit performance of clinical sites; recommend changes to protocol operations based on audit results and revised goals.
- Track proposals and other documentation through signature/approval processes and through collaboration with contracts personnel and IRB Navigators.
- Use professional judgment in handling information and be sensitive to the project team, individual, and all levels of organizational concerns
- Use data, statistical and quantitative analysis, explanatory and predictive modeling, and fact-based management to drive decision making
- Help investigators develop new insights and understanding of performance-based data.
- Serve as liaison and facilitate meetings between project stakeholders and leadership
- Complete and maintain professional documentation for projects and deliverables
- Develop SOPs and assist in the auditing and monitoring of study sites.
- Build and maintain strong, trusting relationships.
- Remain current with a constantly changing clinical research technology and embrace the adoption of innovations to modernize, disseminate, renovate and remodel.
- Serve as a knowledgeable liaison between leadership and the research communities.
- Other duties as assigned.
Then after "In addition to the duties above" there are subheadings with more detailed duties:
MultiSite StartUp & Activation Leadership
- Lead site startup activities across numerous external clinical sites, including feasibility assessments, resource readiness evaluations, activation timelines, and onboarding to centralized IRB and master agreement processes.
Enrollment Performance Management & Remediation
- Actively track sitelevel enrollment metrics, identify underperforming sites, and design customized remediation strategies to address recruitment barriers and keep trials on pace for completion.
Investigator & Site Relationship Management
- Serve as the primary operational liaison for site investigators and coordinators, building trust, setting expectations, assigning deliverables, and holding sites accountable for performance, quality, and timelines.
Operational Oversight of Trial Execution
- Direct and monitor daily site activities related to subject eligibility, randomization, protocol adherence, safety reporting, and investigational product compliance, escalating risks and issues as necessary.
Audit, Quality Review & Continuous Improvement
- Oversee site performance reviews; recommend operational or protocollevel improvements based on performance data and evolving trial needs.
We need to include all these as list items under Responsibilities. Could also separate into subheadings but not required. We'll just list all duties as
About the role
... paragraph containing role overview, location, department, etc.
Responsibilities
- ... each duty
Requirements
- ... minimum qualifications
Qualifications
- ... preferred qualifications
Skills
- ... technical skills
The core technical skills listed are most essential; additional technical skills may be required based on specific division or department needs.
Pay
Starting Salary Range: $57,195 - $100,040 Annually ($78,620 targeted; Commensurate w/exp.)
Schedule
Employee group: Full Time; Schedule: M-F 8:30 am - 5:00 pm; FLSA Status: Exempt; Location: Remote; Department: SOM Neuro BIOS; Personnel area: School of Medicine
We need to ensure we don't repeat job title as heading. Good. Check for any duplicated lines: we must avoid duplication. Ensure each duty appears once. Now produce HTML fragment only. Let's craft the About the role paragraph: combine the initial description: "The Department of Neurology is seeking a Clinical Research Site Manager for the BIOS Division in the School of Medicine. The Clinical Research Site Manager oversees site-level execution of large, multicenter clinical trials by leading site startup, driving enrollment performance, managing investigator relationships, and ensuring consistent protocol implementation across a national network of collaborating clinical sites. The role requires a high degree of independence, operational leadership, and performance-driven site management." Also include location remote and department maybe. We'll include location remote and department name SOM Neuro BIOS and Personnel area