The Oncology Clinical Research Office is seeking a Clinical Research Program Manager. This role involves rigorous development of investigator-initiated protocols, and meticulous preparation of related IND/IDE submissions support the reduction of time-to-approval for clinical trials. The IND and Protocol Development Manager, as part of the centralized Clinical Research Office (CRO), will submit and maintain IND/IDE applications, and be responsible for the overall management of the IND/IDE portfolio in the Cancer Center. This position will also provide guidance and hands-on support for investigators in developing and writing protocols, collaborate with the study team through regulatory start-up and study activation, and conduct pertinent trainings.

Specific Duties & Responsibilities:

• Responsible for preparing initial IND/IDE submissions, as well as various maintenance applications such as amendments, annual reports, and safety reports.
• Provide IND/IDE regulatory advice to new investigators, fellows, and Cancer Center sponsor-investigators.  Work to identify any potential problems, inconsistencies, or risks, and make corrections accordingly.  Explain and interpret FDA regulations and guidance.  Act as FDA liaison for Cancer Center investigators and study teams.
• Assist the Compliance Manager and study team with any FDA audit-related questions or concerns.
• Using CRMS, track detailed information for each IND/IDE, providing reports as necessary for submission to leadership, and for billing.
• Develop a comprehensive education package for new and existing investigators, including in-person or video classes as well as printed materials to be posted on the CRO website.  These will include the basic procedures involved in requesting an IND, maintenance of the IND/IDE, and required reporting to the FDA.
• As a member of the Clinical Research Review Subcommittee (CRCS), review and comment on investigator-initiated protocols, as well as IND/IDEs for compliance with FDA requirements.
• Work with the IRB compliance team when IND/IDE questions arise related to Cancer Center protocols.
• Collaborate with group Program Managers and study staff to develop best practices for requesting, servicing, and tracking INDs/IDEs
• Participate in or lead complex projects involving FDA or federal agency-related regulatory issues, whether clinical or basic laboratory research, providing guidance and strategic oversight to ensure minimal risk for investigators, SKCCC, Johns Hopkins, and patients.
• Provide comprehensive assistance in the development of investigator-initiated protocols, including review, editing, wordsmithing, and guidance on composition and configuration.
• Establish communications with investigators, Clinical Research Groups, Program Managers, and study teams to facilitate timely approval and activation of clinical research projects.  Attend group meetings when appropriate, and organize meetings with investigators study teams for specific developing trials.
• Attend professional development meetings hosted by appropriate agencies and organizations such as the FDA, NIH, NCI, and others, to maintain or enhance expertise in the protocol development area.

Supervision of Others:

• Possible.

Equipment, Machine, or Tool Requirements:

• General computer skills, with experience with Microsoft Office.

Minimum Qualifications (Mandatory):

• BA/BS Degree in Biological/Social Sciences or other appropriate discipline required.
• Master's Degree, Ph.D., or J.D. preferred. 

• Minimum 5 years' experience in research at an academic, government, or pharmaceutical industry regulatory environment.
• Extensive experience with clinical trials, clinical research sciences, and/or regulatory affairs.
• Extensive experience with various aspects of federal and institutional regulatory laws and policy.
• Extensive experience with protocol review.
• Proficiency in the use of software applications, databases, spreadsheets, and word processing required.
• Prior experience managing staff preferred.
• Additional education (graduate level) may substitute for required experience and additional experience may substitute for required education to the extent permitted by the JHU Equivalency Formula.*

* JHU Equivalency Formula: 18 graduate degree credits may substitute for one year of experience.   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 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. 

Licensure, Certification, Registration:

• Certification as a Clinical Research Professional or Regulatory professional is preferred.

Special Knowledge, Skills, or Abilities:

• Excellent organizational skills required.
• Excellent attention to detail skills required.
• Knowledge of medical terminology required.
• Ability to manage multiple and competing priorities.
• Knowledge of research practices and principles required.
• Must have excellent time management skills.
• Must have excellent oral and written communication skills.
• Ability to work in a team and demonstrated interpersonal skills.

Specific Requirements:

• Must adhere to guidelines regarding honest reporting of sensitive and confidential patient information
• Understands the importance/impact of data integrity in terms of patients, study results, costs, quality of service and scientific research in general
• Regular contact with physicians, other health care personnel and occasionally, patients, requires the use of good judgment, tact and sensitivity.
• This description is a general statement of required major duties and responsibilities performed on a regular and consistent basis by the incumbent(s). 
• It should not be held to exclude other duties not mentioned that are similar in nature and level of difficulty.

Classified Title: Clinical Research Program Manager
Role/Level/Range: ACRP/04/MD 
Starting Salary Range: $53,020 - $72,935 annually (commensurate with experience)
Employee group: Full Time 
Schedule: M-F 8am- 3:30pm 
Exempt Status: Exempt 
Location: ​​​​​​​Hybrid/School of Medicine Campus
Department name: ​​​​​​​SOM Onc Clinical Research Office
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 at jhurecruitment@jhu.edu. For TTY users, call via Maryland Relay or dial 711.

Johns Hopkins has mandated COVID-19 and influenza vaccines, as applicable. Exceptions to the COVID and 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. For additional information, applicants for SOM positions should visit https://www.hopkinsmedicine.org/coronavirus/covid-19-vaccine/ and all other JHU applicants should visit https://covidinfo.jhu.edu/health-safety/covid-vaccination-information/.

The following additional provisions may apply, depending on 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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