Clinical Research Manager (Department of Neurosurgery)

Johns Hopkins, founded in 1876, is America's first research
university and home to nine world-class academic divisions working
together as one university.

The Department of Neurosurgery is seeking a Clinical
Research Manager who will work under the general
supervision of a PI(s) to manage the administrative and scientific
implementation of a complex clinical protocol or multiple studies
and/or multiple sites. As part of a study team, the Clinical
Research Manager will collaborate with faculty, develop protocols,
develop SOPs, and supervise study-related activities for one or
more studies. Has accountability for grant submission and
administration and regulatory compliance. Supervise or oversee
other exempt level research staff; may oversee staff at local or
multi-center sites.

Specific Duties & Responsibilities

• Partner with investigator(s) and exercise independent judgement

in managing the conduct of the research on behalf of the PI.

• Participate in scientific discussions with collaborators, PI's,

and funding organizations.

• Collaborate with PI to ensure operational feasibility of

proposed protocol/study design.

• Develop, or oversee the development of standard operating

procedures and data collection forms from protocol(s).

• Develop or oversee the development of consent form(s) for

clinical trials based on protocol(s).

• Oversee preparation and submissions to IRB and act as primary

liaison for regulatory compliance issues on behalf of the PI.

• Train and provide oversight of research data management and

regulatory issues.

• Work with commercial and/or government agency sponsors to

determine what group can commit to considering patient population,
available resources, and cost of providing services.

• Collaborate with the finance team to develop study budget(s)

and ensure that all study costs are included in the budget.

• Ensure clinical research protocol has a completed Prospective

Reimbursement Analysis (PRA) and processes/systems are in place to
ensure the PRA is followed when required.

• Ensure adequate system for tracking and reporting clinical

research milestones for financial invoicing.

• Monitor activities, systems, and processes to increase

referrals and increase accruals to clinical trials.

• Ensure the development, testing, and evaluation of manuals,

questionnaires, and coding structures, for the efficient collection
of data.

• Oversee data collection at a single site or at multiple sites

of a multi-centered clinical trial.

• Lead study meetings to examine data, determine next steps,

implement changes to protocol operations based on results and
goals, and initiate sub-studies.

• Contribute to presentations and manuscripts.
• Hire, supervise and manage the performance of other

exempt-level research staff.

• Other duties as assigned.

Minimum Qualifications

• Bachelor's Degree in a related field.
• Five years of related experience in clinical research in an

academic, government, or pharmaceutical industry environment.

• Demonstrated supervisory or lead responsibilities.
• 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

• Master's Degree in a related field.
• Certification as a Clinical Research Professional.

Classified Title: Clinical Research 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 8:30-5

FLSA Status: Exempt

Location: Hybrid/School of Medicine Campus

Department name: NUS Pain Institute

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.

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

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