Top 8 Clinical research specialist Jobs in Baltimore Md

Regulatory Specialist II (Office of Clinical Trials)
Johns Hopkins University —Baltimore, MD
- $41,300 - $72,300 a year
- Full-time
- Background check
- Mid-level
- Bachelor's degree
Regulatory Specialist II (Oncology)
Johns Hopkins University —Baltimore, MD
- $41,300 - $72,300 a year
- 8 hour shift
- Hybrid work
- Background check
- Mid-level
- University
Regulatory Specialist II (Cardiology)
Johns Hopkins University —Baltimore, MD
- $41,300 - $72,300 a year
- Full-time
- Background check
- Mid-level
- University
10d
Local Enrollment Specialist (Clinical Trial Patient Recruitment)
American Clinical Research Services Opco LLC —Linthicum Heights, MD
- $50,000 - $70,000 a year
- Full-time
- Spanish
- Microsoft Outlook
- Sales
Quick Apply
3d
Patient Recruitment Specialist
Flourish Research —Bowie, MD
- $26 - $28 a year
- Weekends as needed
- Writing skills
- HIPAA
- Mid-level
- Paid holidays
- Disability insurance
Quick Apply
Oncology Data Specialist
University of Maryland Medical System —Towson, MD
- Full-time
- Hybrid work
- Microsoft Word
- Microsoft Excel
- Mid-level
Supervisor, Clinical Data Specialists
Johns Hopkins Health System —Baltimore, MD
- Full-time
- Nursing
- Hospital
- 5 years
9d
Clinical Sales Specialist, Structural Heart, TAVI (Baltimore, MD)
Abbott Laboratories —Baltimore, MD
- $68,000 - $136,000 a year
- Full-time
- 6 years
- Up to 50% travel
- RN License
- Health insurance
- Tuition reimbursement

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Regulatory Specialist II (Office of Clinical Trials)

Johns Hopkins University -
Baltimore, MD

Apply Now

Job Details

Full-time
$41,300 - $72,300 a year

Qualifications

Document compliance management
Filing
Mid-level
Bachelor's degree
Contract drafting
Research compliance clinical trial records management
Contracts
Research administration
Communication with regulatory authorities for clinical trials
Contract management support tasks
Budgeting
1 year
Ethical review application preparation
Research compliance quality assurance records management

Full Job Description

Affiliated Office Address

Baltimore, MD, United States

Requisition ID

121462

Date Created

June 03, 2026

Job Family

Research

Job Subfamily

Research Administration

Job Function

Clerical/Administrative Support

Exempt Status

Exempt

Shift Type

Full Time

Schedule

M-F/37.5

Worksite

04-MD:School of Medicine Campus

Work Modality

Remote: Not on-site or < 10% of hours worked on-site

Under the supervision of the Accelerated Study Start-Up Program Manager, we are seeking a Regulatory Specialist II who will serve as a central resource for faculty conducting clinical research. The Regulatory Specialist II will be assigned to a dedicated portfolio of clinical divisions and their investigators working to facilitate study startup and maintenance of commercially sponsored clinical trials. Startup activities include coordination of internal partners (study teams, central research administrative teams) and external partners (commercial sponsors, CROs), feasibility surveys, coordination and initiation of contract and budget activities, and initial applications to the IRB and other regulatory agencies. Maintenance activities include regulatory activities over the duration of the study such as creating IRB submissions such as change in research, continuing review, protocol event report, etc., and managing required documents in the electronic regulatory binder ensuring they are accurate and up to date.

Specific Duties and Responsibilities

Facilitate accelerated study startup activities including feasibility surveys, coordination and initiation of contract and budget activities, initial applications to the IRB and other regulatory agencies, etc.
Ensure smooth implementation of new trials from conception through study activation.
Monitor, track, and report critical study start-up milestones e.g., IRB activities, processing and finalization of contracts, drafting of a complete budget, etc.
Communicate with, and track activities led by, internal and/or external research team members and collaborators.
Proactively monitor progress and remove barriers to study site activation Serve as liaison between study teams and central research administrative teams.
Anticipate and mitigate risks to study start up.
Assess feasibility and operational needs of new studies.
Attend study startup meetings.
Complete IRB submissions for new studies, obtaining documents from the sponsor or creating all required documents as needed.
Track each protocol through the IRB and subcommittee approval process, evaluate for recurrent problems, develop and implement systems to decrease delays in the approval process.
Collect all required documents prior to study site activation including investigator and personnel medical licenses, CVs, and training documentation.
Produce and maintain an electronic regulatory binder using Advarra eReg to manage all required documents for the entire duration of the study, ensuring they are accurate and up to date.
Create IRB submissions such as change in research, continuing review, protocol event report, etc., as needed for the duration of the study.

Minimum Qualifications

Bachelor's Degree.
Two years of experience in academic, government, or industry-based clinical research.

Familiarity with NIH, GCP, OHRP, and federal regulations for human subject participation in clinical research.
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

One year of experience in a role responsible for study startup activities in interventional clinical trials.

Classified Title: Regulatory Specialist II
Job Posting Title (Working Title): Regulatory Specialist II (Office of Clinical Trials)
Role/Level/Range: ACRP/03/MB
Starting Salary Range: $41,300 - $72,300 Annually ($60,000 targeted; Commensurate w/exp.)
Employee group: Full Time
Schedule: M-F/37.5
FLSA Status: Exempt
Location: Remote
Department name: SOM Admin Res Clinical Research Contract
Personnel area: School of Medicine

Total Rewards
The referenced base salary range represents the low and high end of Johns Hopkins University’s salary range for this position. Not all candidates will be eligible for the upper end of the salary range. Exact salary will ultimately depend on multiple factors, which may include the successful candidate's geographic location, skills, work experience, market conditions, education/training and other qualifications. Johns Hopkins offers a total rewards package that supports our employees' health, life, career and retirement. More information can be found here: https://hr.jhu.edu/benefits-worklife/.

Education and Experience Equivalency
Please refer to the job description above to see which forms of equivalency are permitted for this position. If permitted, equivalencies will follow these guidelines: JHU Equivalency Formula: 30 undergraduate degree credits (semester hours) or 18 graduate degree credits may substitute for one year of experience. Additional related experience may substitute for required education on the same basis. For jobs where equivalency is permitted, up to two years of non-related college course work may be applied towards the total minimum education/experience required for the respective job.

Applicants Completing Studies
Applicants who do not meet the posted requirements but are completing their final academic semester/quarter will be considered eligible for employment and may be asked to provide additional information confirming their academic completion date.

Background Checks
The successful candidate(s) for this position will be subject to a pre-employment background check. Johns Hopkins is committed to hiring individuals with a justice-involved background, consistent with applicable policies and current practice. A prior criminal history does not automatically preclude candidates from employment at Johns Hopkins University. In accordance with applicable law, the university will review, on an individual basis, the date of a candidate's conviction, the nature of the conviction and how the conviction relates to an essential job-related qualification or function.

Diversity and Inclusion
The Johns Hopkins University values diversity, equity and inclusion and advances these through our key strategic framework, the JHU Roadmap on Diversity and Inclusion.

Equal Opportunity Employer
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

EEO is the Law
https://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12ScreenRdr.pdf

Accommodation Information
If you are interested in applying for employment with The Johns Hopkins University and require special assistance or accommodation during any part of the pre-employment process, please contact the Talent Acquisition Office at [email protected]. For TTY users, call via Maryland Relay or dial 711. For more information about workplace accommodations or accessibility at Johns Hopkins University, please visit: https://accessibility.jhu.edu/.

Vaccine Requirements
Johns Hopkins University requires all faculty, staff, and students to receive the seasonal flu vaccine. Exceptions to the flu vaccine requirements may be provided to individuals for religious beliefs or medical reasons. Requests for an exception must be submitted to the JHU vaccination registry.

The following additional provisions may apply, depending upon campus. Your recruiter will advise accordingly.
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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Refine Your Search

clinical research specialist jobs in baltimore md

Regulatory Specialist II (Office of Clinical Trials)

Regulatory Specialist II (Oncology)

Regulatory Specialist II (Cardiology)

Local Enrollment Specialist (Clinical Trial Patient Recruitment)

Patient Recruitment Specialist

Oncology Data Specialist

Supervisor, Clinical Data Specialists

Clinical Sales Specialist, Structural Heart, TAVI (Baltimore, MD)

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