Clinical Research Compliance Specialist

Location
Maryland, United States
Salary
Salary Not Specified
Posted
Apr 21, 2021
Employment Type
Full Time

General summary/purpose:

Clinical research trials are required to be registered and reported in a publically-accessible database under Section 801 of the Food and Drug Administration Amendments Act (FDAAA). This database is called ClinicalTrials.gov. This position within the Institute for Clinical and Translational Research (ICTR) will administer the program to ensure adherence to the Federal regulation relating to the registration and reporting of clinical research across the Johns Hopkins University, School of Medicine.

This individual will report to and work closely with the Director of the Johns Hopkins University ClinicalTrials.gov Program (Program) to develop mechanisms that will ensure ethical standards, scientific integrity and regulatory compliance with ClinicalTrials.gov. This work will involve survey tools, databases, writing Standard Operating Procedures (SOPs), writing training manuals and substantial communication with research program coordinators, research nurses, and/or Principal Investigators (PI) to register, update and report results for all research studies deemed applicable clinical trials.

Specific duties & responsibilities:

Uses survey data to ensure compliance with registration and results disclosure requirements, and escalates to applicable Research Compliance and/or Institutional Officials as outlined by the Program.

Provide survey training and troubleshooting assistance to investigators and stud teams. Responds to feedback to maximize user satisfaction.

Monitors survey performance and conducts quality improvement and quality assurance of survey instruments to enhance collection methods and/or increase response rate.

Using knowledge of applicable laws and regulations, this individual provides guidance on interpretation for clinical trials registration requirements, including those of FDAAA, International Committee of Medical Journal Editors (ICMJE), Center for Medicare and Medicaid Services (CMS), and National Institutes of Health (NIH).

Works with the Office of Human Subjects Research – Institutional Review Boards (IRB) to ensure that all applicable clinical research trials are identified and registered. It includes receiving and responding to notifications as well as generating reports.

Provides guidance and support to the research community regarding the registration and reporting requirements for all clinical research.

Manage access and maintenance of ClinicalTrials.gov system for JHU SOM. This includes ensuring that individuals have access to only trials that they are working, and lose access as appropriate.

Develops and conducts educational training programs related to Clinical Trials transparency to investigators, study teams, and institutional leadership on an ongoing basis.

Prepares data for reports to keep institutional leadership updated via reporting of compliance rates and activities. Analyzes survey data and prepares data for reports and presentations inside and outside the institution.

Manages and updates the Program’s institutional website to ensure it has the latest information on regulatory requirements, links to recent trainings, and links to relevant publications and websites.

Provides one-on-one assistance for investigator initiated trials requiring results reporting. Works with investigators to enter information into ClincalTrials.gov.

Researches and brings retrospective studies into compliance where investigators are no longer available.

Actively participates and engages in the National Clinical Trials Registration Taskforce – a monthly meeting of clinical trial registration experts at Academic Medical Centers (AMC) focusing on clinical trials registration and results reporting issues that affect AMCs. Over time, may take on leadership roles in this group.

Initiates and participates in collaborations with key stakeholders within JHU and at other academic research institutions relating to best practices, quality improvement projects, SOPs, work processes, and knowledge and experiences.

Writes and/or presents abstracts and posters for publications including creation of appropriate tables, graphs and figures.

Performs literature reviews, and keeps current on national and international policies that may affect the Program.

Develop and maintain a database to track interactions for specific research studies so that information is available to everyone working in the office.

Oversees and participates in special event planning for Program activities.

Performs other duties as required.

Minimum qualifications:

Bachelor’s degree in Biological Sciences, Psychology, Public Health or other related discipline required.

Requires a minimum of three years of experience doing clinical research, including work with comparative statistical analysis and exposure to a variety of study designs.

Or:

Requires a minimum of a Master’s degree in Public Health or equivalent. Requires a wide range of knowledge of human anatomy, multiple organ systems, and disease states. Requires a minimum of one year of experience doing clinical research, with emphasis in clinical research design, conduct, and analysis, including work with comparative statistical analysis and exposure to a variety of study designs.

Preferred Qualifications

Experience importing, analyzing and exporting data in statistical software tools (i.e., STATA, SAS, SPSS) is preferred.

Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC) preferred.

Special knowledge, skills, and abilities:

Requires a wide range of knowledge of human anatomy, multiple organ systems, and disease states.

Proficiency with MS Word, Excel and Access is required.

Proficiency with creating, managing and troubleshooting relational databases is desired but on-site training can be done.

Excellent organizational skills and attention to detail skills required.

Must have excellent time management skills including the ability to prioritize time-sensitive tasks.

Must have excellent oral and written communication skills.

Must be able to communicate specific research-focused material to Program Coordinators and/or PIs.

Supervisory responsibility: May supervise one or more as program expands.

Physical requirements for the job:

Sitting in a normal seated position in office setting

Standing and/or walking for extended periods of time

Lifting and/or assisting patients during evaluations within crowded clinical environment

Reaching by extending hand(s) or arm(s) in any direction

Finger dexterity required to manipulate objects with fingers rather than with whole hand(s) or arm(s), for example, using a keyboard

Communication skills using the spoken word

Ability to see within normal parameters

Ability to hear within normal range

Ability to move about

Classified Title:Clinical Research Compliance Specialist
Working Title: Clinical Research Compliance Specialist
Role/Level/Range: ATP/04/PC
Starting Salary Range:$45,195 - $62,225; Commensurate with Experience
Employee group: Full Time
Schedule: Monday-Friday; 8:30am-5:00pm, UP to 37.5 hrs/week
Exempt Status: Exempt
Location: 33-MD:Johns Hopkins Bayview
Department name: 10003311-SOM ICTR Inst Clin Translational Resrch
Personnel area: School of Medicine

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

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 HR Business Services Office atjhurecruitment@jhu.edu. For TTY users, call via Maryland Relay or dial 711.

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.

Equal Opportunity Employer
Note: Job Postings are updated daily and remain online until filled.

EEO is the Law
Learn more:
https://www.eeoc.gov/sites/default/files/migrated_files/employers/poster_screen_reader_optimized.pdf

Johns Hopkins Bayview


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

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 HR Business Services Office at jhurecruitment@jhu.edu. For TTY users, call via Maryland Relay or dial 711.

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.

Equal Opportunity Employer
Note: Job Postings are updated daily and remain online until filled.

EEO is the Law
Learn more:
https://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.pdf
Important legal information
http://hrnt.jhu.edu/legal.cfm

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