Description
The Senior Clinical Research Coordinator (Senior CRC)
contributes to the overall operational management of clinical
research/trial/study activities from design, set up, conduct, through closeout.
The position has responsibility for the implementation of research activities
for one or more studies. The Senior CRC recognizes and performs necessary tasks
to manage projects and prioritizes work to meet necessary deadlines. They are
responsible for planning and organizing necessary tasks to ensure adherence to
the study protocol and applicable regulations, such as institutional policy and
procedures, FDA Code of Federal Regulations (CFR), and ICH Good Clinical
Practice (GCP). The Senior CRC collaborates with the Principal Investigator
(PI), ancillary departments, central research infrastructure teams, sponsors,
institutions, and other entities as needed to support the administration of all
aspects of studies, including, but not limited to, compliant conduct, financial
management, and adequate personnel support.. Performance of duties and tasks
will vary based on the department operations, the type of study and scope of
service.
Salary Range: $93,927.51 - 151,099.73 Annually
Qualifications
Required:
- Minimum of 4+ years of experience in a clinical research
setting.
- Interpersonal skills to
effectively communicate information in a timely, professional manner and
establish and maintain cooperative and effective working relationships with
students, staff, faculty, external collaborators and administration and to work as a member of a team.
- Ability to effectively
communicate and interact with patients in
a compassionate and kind manner.
- Ability to set
priorities and complete ongoing tasks
with competing deadlines, with frequent interruptions, to meet the
programmatic and department needs, while complying with applicable University
policies and federal and state regulations.
- Analytical skills to
assess clinical research protocols and regulatory requirements, define
problems, formulate logical solutions, develop alternative solutions, make
recommendations, and initiate corrective actions.
- Close attention
to detail to ensure accuracy in
a fast-paced, fluctuating workload environment.
- Organization skills to
create and maintain administrative and regulatory files effectively as well as
independently balance the various tasks to ensure deadlines are met.
- Demonstrated proficiency with Adobe
and Microsoft suite software, especially Excel, to perform daily tasks efficiently and accurately.
- A learning and
professional growth mentality so that new software tools, systems, and
processes can be adopted quickly and efficiently.
- Knowledge of and experience with a variety
of local and external IRBs, scientific review and other research committees,
national cooperative group sponsors, industry sponsors, federal and foundation
funding organizations, etc.
- Strong verbal and written
communication skills to effectively establish rapport, building
collaborative relationships, and communicate complex concepts and ideas in an
easy-to-understand manner.
- Ability to adapt to
changing job demands and priorities, remain flexible including working flexible hours to accommodate research
deadlines.
- Ability to handle confidential
information with judgement and discretion.
- High degree of concentration
and focus in a work environment
that contains distracting stimuli, competing deadlines, and work delegated by
more than one individual.
- Availability to work in more than one environment, travelling to various clinic sites,
meetings, conferences, etc.
- Strong knowledge of and experience working with a variety
of local and external IRBs, scientific review and other research committees,
national cooperative group sponsors, industry sponsors, federal and foundation
funding organizations, etc.
- Strong knowledge of clinical research concepts, policies
and procedures, and human safety protection regulations and laws.
- Ability to think creatively to develop solutions affecting
the full team.
- Experience with FDA processes and procedures.
- Sufficient experience and knowledge of clinical trials
budgeting processes to manage the preparation of clinical trials budgets
Preferred:
- Bachelor's Degree in related area and/or equivalent
combination of education and experience. Advanced degree.