Clinical Research Coordinator II-Hosp & RI Factor Program

Nationwide Children's Hospital; North Carolina; On-site; USD 52,000 - 76,000; Full time

Job summary

Nationwide Children's Hospital is seeking a Clinical Research Coordinator to manage elements of a clinical study under ICH/GCP guidelines, coordinate start-up, launch, day-to-day management, and study closure activities. Trains and mentors other CRCs to ensure consistency in study management activities.

Responsibilities include recruiting and enrolling subjects, ensuring protocol compliance, maintaining regulatory binders, and supporting publications and grant proposals.

Qualifications

• Eighteen months experience in clinical research or health care field.
• Associate’s degree or equivalent required; BA/BS preferred.
• CRA/CRC certification preferred.
• Understanding of medical terminology and clinical trials preferred.
• Excellent verbal and written communication skills.
• Strong organizational and interpersonal skills.
• Ability to manage complex projects independently.

Responsibilities

• Conducts clinical studies per protocol and adheres to ICH/GCP.
• Recruits, consents and enrolls subjects according to regulations; ensures rights and safety.
• Coordinates visits, manages protocol data, and conducts procedures per qualifications.
• Identifies issues and develops solutions to keep studies on track.
• Assists with recruitment plans and maintains study logs and CRFs.
• Creates source documents and supports data collection and record keeping.
• Supports study database development and regulatory binder maintenance.
• Educates staff on study responsibilities and documents training.
• Alerts investigators when safety, protocol deviations, or termination requests occur.
• Assists PI with publications and grant proposals.

Skills

Clinical trials

Medical terminology

Data management

Communication skills

Organizational skills

Team collaboration

Problem solving

Education

Associate degree

BA/BS preferred

Tools

Word processing

Data management software

PCs

Job description

Overview:

Job Description Summary:

Manages elements of a clinical study to meet protocol obligations while following ICH/GCP guidelines and departmental/institutional standard operating procedures. Coordinates start-up activities, launch activities, day-to-day management of a study, and study closure activities. Trains and mentors other CRC’s to ensure consistency in study management activities.

Job Description:

Essential Functions:

• Conducts clinical studies as outlined in the study protocol; discerns critical elements of the protocol to ensure subject safety throughout study; adheres to good clinical practices.
• Recruits, consents and enrolls subjects according to ICH/GCP regulations, and subjects’ rights through institutional IRB, federal and state regulations; Ensures the subject meets inclusion/exclusion criteria; answers questions related to the protocol procedure as applicable; acts as a patient/family advocate;
• Coordinates, and schedules subject study visits with other hospital services and the PI/sub-I; manages protocol required data; performs study procedures according to recognized skill level and certifications and within the local and federal regulations and guidelines; collects, processes and ships human specimens for use in research studies
• Identifies study implementation and/or study management issues and works with the study team to develop and implement solutions to ensure study progress and success
• Assists with the study recruitment plan and provides input into the study budget; manages all screening, enrollment and study participation logs; completes recruitment summary at study termination.
• Creates source documents that facilitate systematic data collection and/or aid in protocol execution and management and record keeping; and conducts accurate and timely subject data collection,
• Assists with study database development to maintain study data in de-identified format, according to recognized skill level; completes Case Report Forms (CRF’s) and ensures CRF’s are completed prior to monitor visits.
• Educates other study personnel with regards to study-specific responsibilities and keeps written documentation of this training.
• Alerts the investigator when the subject’s safety is in jeopardy, there is a protocol deviation, or when the subject requests premature study termination.
• Responsible for regulatory/IRB issues after a study has been initiated; maintains regulatory binder.
• Assists the principal investigator in the preparation of scientific publications and grant proposals.

Education Requirement:

• Associate’s degree or equivalent work-related experience, required.
• BA/BS, preferred.

Licensure Requirement:

(not specified)

Certifications:

CRA/CRC certification, preferred.

Skills:

• Understanding of medical terminology and clinical trials preferred.
• Working knowledge of PCs and word processing and data management software.
• Demonstrated analytical skills with accuracy and attention to detail.
• Excellent verbal and written communication skills.
• Goal-oriented and self-directive, ability to manage complex projects independently.
• Strong organizational and interpersonal skills.
• Ability to actively participate as a team player.

Experience:

Eighteen months experience in clinical research or health care field, required.

Physical Requirements:

OCCASIONALLY: Cold Temperatures, Driving motor vehicles (work required) *additional testing may be required, Fume /Gases /Vapors, Loud Noises, Reaching above shoulder, Squat/kneel

FREQUENTLY: Bend/twist, Biohazard waste, Blood and/or Bodily Fluids, Chemicals/Medications, Communicable Diseases and/or Pathogens, Lifting / Carrying: 0-10 lbs, Lifting / Carrying: 11-20 lbs, Lifting / Carrying: 21-40 lbs, Machinery, Patient Equipment, Pushing / Pulling: 0-25 lbs, Pushing / Pulling: 26-40 lbs, Pushing / Pulling: 41-60 lbs, Pushing / Pulling: 61-100 lbs, Sitting, Standing, Walking

CONTINUOUSLY: Audible speech, Computer skills, Decision Making, Depth perception, Flexing/extending of neck, Hand use: grasping, gripping, turning, Hearing acuity, Interpreting Data, Peripheral vision, Problem solving, Repetitive hand/arm use, Seeing – Far/near

Additional Physical Requirements performed but not listed above:

(not specified)

“The above list of duties is intended to describe the general nature and level of work performed by individuals assigned to this classification. It is not to be construed as an exhaustive list of duties performed by the individuals so classified, nor is it intended to limit or modify the right of any supervisor to assign, direct, and control the work of employees under their supervision. EOE M/F/Disability/Vet”