Neurology Clinical Research Project Manager
Company: Cleveland Clinic
Location: Cleveland
Posted on: May 28, 2023
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Job Description:
Join Cleveland Clinic's Main Campus where research and surgery
are advanced, technology is leading-edge, patient care is
world-class, and caregivers are family. Cleveland Clinic earned the
No. 1 hospital ranking in Ohio, the No. 4 hospital ranking in the
country, and was ranked nationally in 13 specialties, according to
the U.S. News & World Report. At Cleveland Clinic, you will work
alongside passionate and dedicated caregivers, receive endless
support and appreciation, and build a rewarding career with one of
the most respected healthcare organizations in the world.
Cleveland Clinic provides what matters most: career growth,
delivering world-class care to our patients, continuous learning,
exceptional benefits and working for an organization that offers
many long-term career paths. Join us and experience a culture where
opportunities to advance and the support to get there go
hand-in-hand.
Oversees the administrative functions of single and/or
multi-institutional research trials. Coordinates/Manages daily
organization and operational issues/activities related to Phase
I-IV clinical research trials. Facilitates key trial communications
for academic coordination, provides clinical perspective to the
design and conduct of clinical trials.
Responsibilities:
Manages and coordinates a clinical trials team (external industry
team members, statisticians, database programmers and researchers)
responsible for data accumulation, input and analysis.
Interacts with the Finance and Legal departments to facilitate
clinical trial budget, site budget and contract execution.
Maintains professional relationships with Sponsor including
frequent, open communication and associated documentation.
Coordinates development, preparation, review and approval of
research protocols, case report forms and regulatory documents for
the conduct of research required by Institutional Review Board
(IRB), Sponsor and FDA. Collect and review regulatory documents
from sites.
Communicates with institutional and central IRBs, FDA and other
parties regarding protocol subject and safety issues.
Organizes, coordinates, attends and participates in Investigator
Meetings and training programs.
Develops and maintains planned communication with sites (i.e.,
newsletters, study progress updates, telephone communication,
supportive reinforcement of Sponsor communication, etc.).
Analyzes site strengths and weaknesses related to intended protocol
and selection of qualified investigators and sites.
Assesses investigator and site performance.
Lead initiative to improve quality and makes recommendation to
discontinue site if necessary.
May assist with the development, implementation and evaluation of
research subject recruitment strategies, including marketing
strategies, to maximize enrollment and retention.
Performs other duties as assigned.
Education:
Certifications:
Complexity of Work:
Requires excellent interpersonal, organizational and project
management skills.
Substantial scientific and medical knowledge across relevant
therapeutic areas.
Demonstrated ability to work with multiple software
technologies.
Knowledge of FDA regulations, GCPs, and internal SOPs.
Knowledge of Code of Federal Regulations, ICH and GCP guidelines
and their applications to clinical research trials.
Within 90 days of hire, must successfully complete training in
Human Subjects Research (HSR) as required by the Responsible
Conduct of Research guidelines adopted by the Cleveland Clinic.
Supervisor experience desirable.
Demonstrated background/ability or working with clinical studies
and clinical research team members at all levels.
Work Experience:
Minimum three years clinical research experience as a Study
Coordinator, Project Manager, Contract Research Associate or
equivalent management experience in a related field.
Offset: Associate's degree and five years of experience.
Offset: Master's degree and two years of experience.
Preferred Qualifications:
Physical Requirements:
Requires full range of motion, manual and finger dexterity and
eye-hand coordination.
Requires standing and walking for extensive periods of time.
Requires normal or corrected hearing and vision to normal
range.
Personal Protective Equipment:
Keywords: Clinical Research Project Manager, Neuro, Grants,
Funding, Human Subject Research
Cleveland Clinic Health System is pleased to be an equal employment
employer: Women / Minorities / Veterans / Individuals with
Disabilities
Keywords: Cleveland Clinic, Cleveland , Neurology Clinical Research Project Manager, Executive , Cleveland, Ohio
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