CLINICAL RESEARCH COORDINATOR
Company: Global Pharma Tek
Location: Chapel Hill
Posted on: November 15, 2024
|
|
|
Job Description:
Title: Clinical Research Coordinator
Location: Chapel Hill, NC 27516 (Hybrid)
Duration: 3 Months
Required:
Nice to Have:
This position will serve as a Senior Clinical Research Coordinator
with the Better Tomorrow Network within the Institute for Trauma
Recovery (Department of Psychiatry).
The Senior Clinical Research Coordinator is responsible for the
planning, organization, conduct, and evaluation of multi-faceted
clinical research protocols, including study execution, developing
strategies and solutions to improve study processes and execution,
providing reviews of other team members' work product, and serving
as mentor and subject matter expert.
The BTN Coordinator will independently provide clinical research
administration and study coordination. The Coordinator will work
alongside the BTN Manager and PI to advance BTN's mission, and will
help manage research staff and student volunteers working on BTN
studies. This position will be responsible for a broad range of
duties related to planning, organizing, executing, and monitoring
the implementation of new and existing studies and other research
initiatives.
Duties will include supporting the PI and BTN Manager with
maintaining research methods, tracking patients in the study,
providing feedback and suggestions on the development/revision of
research protocols and regulatory correspondence, and maintaining
accurate and updated manuals of procedures for the studies. This
position will serve as lead coordinator on one or more BTN studies.
The Coordinator will also help oversee the network of partnering
sites and contribute to the identification, selection, and
negotiation of additional sites and studies, ensuring that
partnering sites have the skill level and availability necessary to
properly conduct the research. This position will also ensure that
BTN staff are adhering to the appropriate SOPs and achieving
excellence in patient/participant care.
Due to the nature of the research (sexual assault) and the
geographical spread of study sites across time zones, typical
encounters are after business hours and on the weekends, therefore
it is typical that the position will provide support, respond when
a potential research subject has been identified and make
decisions.
Knowledge - Professional - Professional knowledge and skill in
social/clinical research principles, methods and processes
(technical and/or theoretical) used to conduct a systematic and
objective inquiry including study design, methods of
data/information collection and analysis, and interpreting and
reporting results. Knowledge of statistics and related information
technology and database storage and management. Ability to keep
current with developments and trends in area(s) of expertise.
Project Design - Ability to plan and coordinate methods and
techniques to meet social/clinical research objectives, including
project resources, methods of data/information collection, and
quality control.
Project/Program Administration - Ability to manage (i.e., direct
the affairs or interests of) and administer social/clinical
research project(s)/program(s) tasks, activities, protocols, and
timelines. Ability to manage resources and monitor activities
associated with the progression of the project(s)/program(s).
Data/Information Analysis/Management - Ability to monitor, collect,
and maintain research data/information to assess its accuracy,
validity, and integrity. Ability to interpret and evaluate results.
Ability to prepare reports and/or presentations. Ability to conduct
trend and impact analysis. Ability to project probable outcomes.
Ability to create and maintain databases and apply criteria for
interaction of data.
Communication - Ability to convey clear and concise information
verbally and in written form. Ability to effectively present ideas
to individuals or groups to ensure that they understand the
information and message. Ability to present research results and
summaries and adhere to reporting requirements of research
project(s)/program(s). Ability to contribute to the writing of
publications, reports, and products.
Instruction - Ability to instruct and train staff, students,
faculty and/or other clients in the performance of procedures and
operation of equipment.
Principal Responsibilities
Supervision/Management:
Better Tomorrow Network Team Development and Training
Proactively identify areas for study team improvement related to
study execution (e.g., recruitment, retention, study visit flow,
etc.), develop and implement solutions.
Provide training in and oversee all areas of clinical research as
necessary.
Assist with the planning and development of training for junior
personnel.
Assist with the onboarding of new personnel.
Provides full supervision to research assistants and student
interns, including management of the performance review process and
disciplinary issues as needed. Set work schedules and approve leave
requests.
Research - Project Management
Study Coordination
The coordinator of a study will be the individual responsible for
tracking participants through the study, and for knowing what
procedures need to be done and when they need to be done. Depending
on the study, certain tasks of the study may be performed by RAs,
but the buck always stops with the coordinator. That is, the
coordinator is ultimately responsible for the completion of all
study-related tasks and the excellent overall conduct of the study.
The coordinator owns the study. The tasks of this work are too
numerous and varied to list, but examples of tasks that fall under
this work include:
Lead the coordination of study start-up activities and project
planning, including development of materials such as study
protocols and grant proposals.
Independently develop standard operating procedures to promote
quality assurance and standardized best practices, as
applicable.
Assist in overseeing site initiation, study start-up meetings, and
closeout for research studies. Lead meetings as applicable.
Assess the needs of various research studies and employ strategies
to optimize recruitment and retention rates. Oversee the
recruitment and screening of research participants.
Assess the needs of a project, employ strategies, and make changes
to optimize study visit flow.
Create complex source documentation, checklists, and/or other
resources to aid with compliant data collection.
Develop complex data management tools/systems.
Track and report study expenditures. Contribute to the development
of study budgets and assist with invoicing funders as
applicable.
Make recommendations in the area of the research project as
necessary.
Maintain up to date administrative and regulatory documents (e.g.,
IRB, CoC).
Ensure study records and extraction forms are completed in a timely
manner.
Develop and maintain updated and accurate Manuals Of Procedures for
studies. (This MOP is the master directions for the study, so that
anyone could pick up this manual and understand how to conduct the
study from beginning to end. MOPs are sometimes provided by
companies for industry-sponsored studies.)
Research Administration
Network Coordination
Perform the following, as requested:
Oversee current network of partnering sites.
Lead site engagement.
Lead the identification, selection, and negotiation of additional
studies and sites.
Design methods of successfully operationalizing studies.
Develop and maintain methods for identifying eligible patients,
consenting patients, and performing follow-up assessments.
Research Compliance
Regulatory and Compliance
Perform reviews of regulatory submissions and materials from study
staff; provide correction and feedback as necessary.
Ensure study staff follow best practices for regulatory
documentation.
Create and maintain administrative study documentation (e.g.,
delegation of authority logs, training records).
Develop and submit complex regulatory applications and/or study
materials (e.g., recruitment materials, informed consent
forms).
Identify, gather, and store required regulatory documentation.
Prepare for study monitoring, coordinate and participate in
monitoring visits, resolve queries and decide corrective action to
be taken, as applicable. Convey major points of monitoring reports
to the Principal Investigator and supervisory personnel. Track,
document, and report protocol deviations and adverse events. Lead
the conduct of root cause analyses (RCAs) and development of
corrective action plans (CAPAs).
Keywords: Global Pharma Tek, Durham , CLINICAL RESEARCH COORDINATOR, Healthcare , Chapel Hill, North Carolina
|
Click
here to apply!
|
