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CLINICAL RESEARCH COORDINATOR

Job description


diversity employer



CLINICAL RESEARCH COORDINATOR
Medicine-Pulmonary

Occ Summary


Participate in or lead day-to-day operations of clinical research
studies conducted by principal
investigator(s) atDuke Medicine; perform a variety of duties involved
in the collection, compilation,
documentation, and analysis of clinical research data. May oversee the
work of junior staff.


Work Performed


1.Clinical research operations. Screen, schedule, consent, and
collect adverse events (AE) information for participants in a variety
of studies. Maintain subject
level documentation, including documentation of consent in the
electronic medical record. Prepare
documents, equipment, or supplies for research visits. Conduct and
document visits and protocol-
specific testing/interviews according to study protocol, operational
plans of clinical departments,
and Standard Operating Procedures (SOPs) for all types of studies
independently. Employ
strategies to maintain recruitment and retention rates,and to assist
participants with individual
needs. Evaluate processes to identify issues related to recruitment and
retention rates. May
provide training to personnel.


Collect, prepare, process, ship, and maintain inventory of research
specimens and train others in
these tasks; improve systems related to specimen handling.


Prepare for study monitoring or study audit visits. Assist with
addressing and correcting findings.


Develop or provide input for IRB documents. Maintain, or collaborateto
maintain, appropriate
study-level documentation.


Assist with management of Investigational Products (IP). Employ the
required system for
handling, dispensing and documentation of IP for sponsored protocols.
May be responsible for
determining the best methods for handling IP for Investigator-initiated
protocols, or coordinating
with investigational pharmacies as necessary. Maintain appropriate
documentation. Track IP
compliance at the protocol-and subject level.


2.Ethical and participant safety considerations. Maintain
familiarity with the ethical conduct of research and safeguards needed
when conducting research.
Train junior staff in the ethical conduct of research. May help in the
design of studies so they
include specific safeguards to ensure ethical conduct and protect
vulnerable populations.
May develop, or assist with the development of, documents related to
safety and security.


Communicate to research participants the difference between clinical
activities and research
activities, and the risks and benefits of study participation.


3.Data management and informatics. Use and train others in
Electronic DataCapture (EDC) systems, technologies, and software
necessary for study
operations. Score tests, enter data, and complete Case Report Forms
accurately and according to
protocol. Assist with the development of, or develop, data collection
documents and instruments.
Detect issues related to data capture, collection or management;
suggest solutions.


Investigate incomplete, inaccurate, or missing data/documents to ensure
accuracy and
completeness of data; follow and develop, or assist with development
of, SOPs for dataquality
assurance. Adhere to processes and run queries, summaries, and reports
to monitor the quality of
data. May develop QA processes and oversee the creation and use of
queries, summaries, and
reports for quality assurance purposes. May be responsible for
recognizing trends related to data
quality and escalating as appropriate.


Use required processes, policies, and systems to ensure data security
and data provenance.
Recognize and report vulnerabilities related to security of physical
and electronic data; suggest
and implement solutions to vulnerabilities related to security of data
and data
provenance.


4.Scientific concepts and research design. Understand and train others
in the basic concepts of
study design. Independently conduct literature reviews.Assist with the
development of, or develop,
proposals or protocols; identify shortcomings of proposals and
protocols.


Identify various stakeholders (statistical, operational, etc.) to
ensure adequate design,
implementation, and testing of study aims. May determine
operational/statistical elements needed
for conduct of clinical and translational studies.


5.Leadership and professionalism. Assist research colleagues in
identifying efficiencies and
improving process. Successfully take part in or lead a committee or
task force. Actively seek out
continuing education opportunities for self and study team members.
Participate in or lead
scientific presentations and publications.


Assign, review, and train others in various work responsibilities.
Serve as a mentor to junior staff,
including other CRCs. Employ escalation and performance plans as
needed.


Recognize and employ the professional guidelines and code of ethics
related to the conduct of
clinical research; summarize and clarify for study teams. May be
responsible for identifying
potential problems and risks to the participants, study, and
institution.


6.Study and site management. Participate in sponsor-required
training. Obtain information for or coordinate operational plans for
multiple research studies.
Develop protocol-specific systems and documents including process
flows, training manuals,
SOPs, and CRFs.


Ensure participant care expenses have appropriate financial routing.
Monitor financial study
milestones and report appropriately. Coordinate with financial teams,
PRMO, etc. Assist with
study budgets.


Prepare for, take part in, and potentially lead site initiation,
monitoring, closeout visits, and
document storage activities.


Collect information to determine feasibility, recruitment and retention
strategies. May make
recommendations to investigators and oversight
organization(s).


Maintain compliance with institutional requirements and policies.
Oversee maintenance of
Delegation of Authority Logs and training of KP on study specific
duties.


7.Communication and team science. Prepare for and lead team
meetings. Take an active role in including others in decision-making,
and escalate issues
appropriately.


Communicate with sponsors, subcontractors, or vendors. May be
responsible for taking action
when communication has stalled with sites, CROs, sponsors.


Maintain Duke and project specific training requirements. Develop
solutions to proactively ensure
study team members' compliance with training requirements.


Evaluate the need for cultural diversity and cultural competency in the
design and conduct of
clinical research. Make recommendations toinvestigative team.


Knowledge, Skills and Abilities


Can easily use computing software and web-based applications (e.g.,
Microsoft Office products
and internet browsers).

Requisition Number
401489655

Location
Durham

Duke Entity
MEDICAL CENTER

Job Code
1201 CLINICAL RESEARCH COORDINATOR

Job Family Level
52

Exempt/Non-Exempt
Exempt

Full Time / Part Time
FULL TIME

Regular / Temporary
Regular

Shift
First/Day

Minimum Qualifications
Duke University is an Affirmative Action/Equal Opportunity Employer
committed to providing employment opportunity without regard to an
individual's age, color, disability, gender, gender expression, gender
identity, genetic information, national origin, race, religion, sex,
sexual orientation, or veteran status.

Duke aspires to create a community built on collaboration, innovation,
creativity, and belonging. Our collective success depends on the robust
exchange of ideas—an exchange that is best when the rich diversity of
our perspectives, backgrounds, and experiences flourishes. To achieve
this exchange, it is essential that all members of the community feel
secure and welcome, that the contributions of all individuals are
respected, and that all voices are heard. All members of our community
have a responsibility to uphold these values.

Essential Physical Job Functions:
Certain jobs at Duke University and Duke University Health System may
include essential job functions that require specific physical and/or
mental abilities. Additional information and provision for requests for
reasonable accommodation will be provided by each hiring department.


Education

1.Completion of a Bachelor's degree
2.Completion of an Associates degree plus a minimum of two years
relevant experience (e.g., research, clinical, interaction with study
population, program coordination)

Auto req ID

104827BR

Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, gender expression, gender identity, national origin, race, religion, sexual orientation, or veteran status.

Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.

PI105452052

 

 

 

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Job No:
Posted: 11/7/2018
Application Due: 1/6/2019
Work Type:
Salary: