Clinical Research Coordinator II - RI Gene Therapy

• 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/subI; 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 and management and record keeping; and conducts accurate and timely subject data collection
• Assists with study database development to maintain study data in deidentified format according to recognized skill level; completes Case Report Forms (CRFs) and ensures CRFs are completed prior to monitor visits.
• Educates other study personnel with regards to studyspecific responsibilities and keeps written documentation of this training.
• Alerts the investigator when the subjects 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.

• Associates degree or equivalent workrelated experience required.
• BA/BS preferred.

(not specified)

CRA/CRC certification preferred.

• 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.
• Goaloriented and selfdirective ability to manage complex projects independently.
• Strong organizational and interpersonal skills.
• Ability to actively participate as a team player.

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

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: 010 lbs Lifting / Carrying: 1120 lbs Lifting / Carrying: 2140 lbs Machinery Patient Equipment Pushing / Pulling: 025 lbs Pushing / Pulling: 2640 lbs Pushing / Pulling: 4160 lbs Pushing / Pulling: 61100 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

(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