Manages elements of a clinical study in order to meet all protocol obligations while following ICH/GCP guidelines; and departmental/institutional standard operating procedures. These elements include but are not limited to; start-up activities, launch activities, day to day management of a study and study closure activities.
Essential Functions:
- Recruits, consents and enrolls subjects according to ICH/GCP regulations, and subjects’ rights through institutional IRB, federal and state regulations; answers questions related to the protocol procedure as applicable; acts as a patient/family advocate.
- Ensures that the subject meets inclusion/exclusion criteria; alerts the investigator when the subject’s safety is in jeopardy, there is a protocol deviation, or when the subject requests premature study termination.
- Collects and manages research data and subject information; and maintains accurate data collection of all study data; including laboratory analytical procedures.
- Prepares and processes human specimens for use in research studies. Collects blood, urine, and other samples as needed according to skill level and certifications. Performs CLIA waived laboratory assessments. Such activities may be performed independently and may require evening and weekend hours.
- Completes screening sheets and recruitment logs.
- 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.
- Collaborates, coordinates, and schedules subject study visits with other hospital services and the PI/sub-I.
- Adheres to departmental quality control guidelines.
- Completes Case Report Forms (CRFs) as instructed by the sponsor; ensures CRF’s are completed prior to monitoring visits.
- Maintains regulatory binder and documents.
Education Requirement:
- Associate's Degree, or equivalent certification or experience, required.
- Bachelor's Degree, preferred.
Certifications:
- CNA, PCA, LPN, MA, or equivalent education or experience, required.
- Clinical Research Associate (CRA) or Clinical Research Coordinator (CRC) certification after hire, required.
Skills:
- Understanding of medical terminology and clinical research 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
- Strong organizational and interpersonal skills.
- Ability to actively participate as a team player.
Experience:
Previous experience in clinical research or health care related field preferred.
Physical Requirements:
OCCASIONALLY: Cold Temperatures, 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
"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"
