Overview:
Job Description Summary:
Manages elements of a clinical study to meet all protocol obligations while following ICH/GCP guidelines and standard operating procedures. Includes elements such as start-up activities, launch activities, day-to-day management, and study closure activities.
Job Description:
Essential Functions:
- Recruits, consents, and enrolls according to regulations and subjects' rights through institutional IRB, federal, and state regulations, while adhering to quality control guidelines and institutional standards. Collaborates, coordinates, and schedules subject study visits and research activities with other hospital services, multidisciplinary teams, clinicians, statisticians, and community partners.
- Ensures inclusion and exclusion criteria. Alerts related to safety issues, protocol deviations, or premature study termination requests. Conducts research visits, interviews, surveys, behavioral assessments, or other study procedures. Answers questions related to protocol procedures as applicable and acts as an advocate. Assists with participant recruitment and retention strategies in clinical, hospital, or community settings.
- Collects, manages, and organizes research data through database entry, data quality checks, and preparation of datasets for analysis. Organizes subject information and creates source documents that facilitate systematic data collection that aid in protocol execution, management, and record keeping.
- Completes required study documentation, Case Report Forms (CRFs) or equivalent study documentation on time and maintains regulatory binders in accordance with institutional and sponsor requirements. Assists in drafting IRB materials, including protocols, consents, assents, and information sheets.
- Supports investigators with literature reviews, reference library management, and preparation of manuscripts, abstracts, and presentations. Disseminates research findings through reports, publications, and presentations.
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 or Clinical Research Coordinator certification, preferred.
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"