Icon hamburger
US
What job do you want?
Apply to this job.
Think you're the perfect candidate?
Apply Now
Thumsup

You’re being taken to an external site to apply.

Enter your email below to receive job recommendations for similar positions.
Default4

Clinical Research Manager / Clinical Trials Manager

Medix New Haven Full-Time
$35.00 - $40.00 / hour
Apply Now

Clinical Research Manager

The individual will function as administrator, coordinator, consultant, educator and
researcher in research trial management and will be involved in all aspects of clinical trials
research, including data collection, analysis, and/or monitoring. The Research Manager will
initiate the grant application process, complete all IRB requirements, develop strategic plans
for protocol implementation, enroll patients, manage protocols, supervise research support
personnel, analyze and interpret research data and provide management reports.

Responsibilities

● Manage research personnel
● Completion of GCP, HIPAA and applicable regulatory training
● Complete certification requirements for assigned protocols
● Screen designated schedules or patient lists for eligible subjects
● Approach and verify eligibility subjects
● Consent and enroll eligible subjects
● Complete research study visits as delineated in assigned protocol and manual of
operations set forth by sponsor and supervisor.
● Complete Telephone follow-up and telephone reminder calls for study participants,
during these phone calls the person will need to administer study questionnaire as
assigned
● Coordinate the collection of all research data points as assigned, whether through
research visits, chart abstraction or telephone.
● Scheduling of research visits
● Collection through veni-puncture of biological specimens
● Processing, transporting and shipping of biological specimens as assigned and
following of instructions as delineated in the protocol or manual of operations.
● Completion of study documents and files; some examples might include case report
forms, worksheets and medical record notes.
● Maintain confidentiality of documents and files such as HIPAA.
● Informing relevant clinical staff regarding subject protocol participation.
● Assist in other research related activities and projects as needed
● Regular collaboration with the PI and other research staff
● Lead CRC of project or network
● Develop and maintain procedures for organizing work and staff
● Attend investigator meetings as needed
● Carry out required staff training and provide the direct supervision for assigned staff

● Maintenance of study documents and files, such as regulatory binders and CVs etc.
● Preparation and completion of feasibility surveys
● Develop plans for protocol implementation, identify necessary resources and request
as appropriate. This includes instruments, equipment and staff.
● Determine recruitment objectives and develop systems to monitor and track
achievement
● Carry out required staff training and provide the direct supervision for clinical
research staff
● Develop all day to day plan and procedures for data collection as well as data
confidentiality and data security.
● Responsible for mechanisms and details of protocol adherence and for providing
administrative back-up to PI
● Preparation and submission of annual reports and regulatory information to funding
and regulatory agencies
● Develop local systems for secure storage of drugs and supplies and be the point of
contact for the research pharmacy
● Preparation of IRB applications
● Preparation and submission of regulatory documentation to the regulatory bodies as
relevant
● Assist investigators with validation and editing of collected data
● Analyze study data and assist in preparing manuscript
● Development of project budgets
● Work closely with central Research Administration team on post-award monitoring of
sponsored research expenditures

Minimum Qualifications

● Bachelor's degree or equivalent in education and experience, plus four years of
related experience.
● Experience in a clinical research setting, especially randomized controlled trials:
Industry sponsored research experience. Experience with budget maintenance,
government grants and contract and/or clinical trials management
● Experience interacting with of patients
● Experience with personnel management
● Capable of working on multiple studies and multi-tasking
● Knowledge of medical terminology
● Excellent interpersonal, written/oral communication, and organizational skills are
required

keywords: clinical research, clinical research manager, oncology research, regulatory, phlebotomy, management, CRC, CR Manager,

Minimum Qualifications ● Bachelor's degree or equivalent in education and experience, plus four years of related experience. ● Experience in a clinical research setting, especially randomized controlled trials: Industry sponsored research experience. Experience with budget maintenance, government grants and contract and/or clinical trials management ● Experience interacting with of patients ● Experience with personnel management ● Capable of working on multiple studies and multi-tasking ● Knowledge of medical terminology ● Excellent interpersonal, written/oral communication, and organizational skills are required

Location

About the company

Salary Details

Based on Job Title, Location and Skills
$37
Below Avg. Average Above Avg.
Apply to this job.
Think you're the perfect candidate?
Apply Now

Help us improve CareerBuilder by providing feedback about this job: Report this job

Report this Job

Once a job has been reported, we will investigate it further. If you require a response, submit your question or concern to our Trust and Site Security Team

Job ID: 86999

CAREERBUILDER TIP

For your privacy and protection, when applying to a job online, never give your social security number to a prospective employer, provide credit card or bank account information, or perform any sort of monetary transaction. Learn more.

By applying to a job using CareerBuilder you are agreeing to comply with and be subject to the CareerBuilder Terms and Conditions for use of our website. To use our website, you must agree with the Terms and Conditions and both meet and comply with their provisions.