Clinical Research Coordinator

Clinical Research Coordinator Job Description

The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the direction of a Project Manager and Principal Investigator (PI) on multiple research studies. While the Principal Investigator is ultimately responsible for the clinical trial, the CRC is responsible for the facilitation and coordination of the daily clinical trial activities and plays a critical role in the conduct of the study, and is supported by a Project Manager. The CRC works collaboratively with the entire OMRC team, pharmaceutical sponsors, and site monitors to ensure productivity and timely completion of studies, and reports to the Project Manager.

Essential Functions:
Utilizing Good Clinical Practice (GCP), the CRC ensures assigned studies are conducted in accordance with the guidelines of the Food and Drug Administration (FDA) and Office for Human Research Protections (OHRP):

Clinical Research Functions:

• Ensures site compliance with research protocols by reviewing all regulatory requirements to confirm implementation of appropriate methods, practices, and procedures for all research activities
• Works with the PI to manage the day-to-day activities of the study including problem solving, communication and protocol management
• Develops accurate source materials and ensures compliance from site staff
• Provides accurate and timely data collection, documentation, entry, and reporting in both sponsor and OMRC databases
• Ensures appropriate credentialing and training of the entire OMRC team
• Supports the regulatory staff in the maintenance of regulatory documents in accordance with OMRC standard operating procedure and applicable regulations
• Completes study documentation and maintains study files in accordance with sponsor requirements and OMRC policies and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms
• Interfaces with research patients including supporting efforts of the clinical staff to determine eligibility, obtain informed consent, collect vitals signs and other data, photographs, disbursing investigational drug, administrating injections and teaching patient administration according to protocol
• Maintains effective and ongoing communication regarding specific study requirements with the research team, including internal and external parties, sponsor, monitors, PI, and study participants during the course of the study
• Ensures compliance with research protocols, by providing ongoing quality control audits, including maintaining ongoing investigational drug accountability
• If delegated, disburses investigational drug and provides patient teaching regarding administration, as necessary
• Collaborates with PI and institution to respond to any audit findings and implement approved recommendations

Other:

• Maintains knowledge of and employs OMRC’s Standard Operating Procedures
• Participates w/ PI and study team to identify and prioritize the development of systems and infrastructure to maintain research quality and compliance
• Completes and maintains training, and all activities for every study in which he/she is delegated
• Required occasional paid travel to attend out-of-state study training meetings
• No supervisory responsibilities
• Other duties as assigned
• CPR-certification required (can attain through OMRC)

Qualifications:

• Required: Bachelor’s Degree
• Preferred candidates will have one or more years of experience as a clinical research professional (Certification as a CCRC is desired)
• Knowledge of medical terminology, clinical medicine, clinical trials and GCP concepts
• Preferred candidates will be fluent in both English and Spanish (written and spoken)
• Detail oriented and meticulous in all aspects of work
• Strong follow through skills and ability to proactively identify and solve problems; demonstrated initiative is imperative
• Must have professional demeanor, strong communication skills with the public as well as physicians/researchers
• Ability to work well independently, as well as in team environment
• Strong interpersonal, customer service and multi-tasking skills are critical
• Must be proficient in Microsoft Office Word and Excel, electronic health systems and databases used in research environment, or have a willingness to learn and demonstrate proficiency within six months of hire
• Ability to be flexible, organized, detail oriented and tenacious in follow-through
• Possess the ability to work well under pressure, multi-task and manage deadlines
• Knowledge of GCP, federal, state, and local regulations, including HIPAA policies and procedures

Physical Requirements

• Physical Requirement - Feeling (sensing textures and temperatures) (Frequently)
• Physical Requirement - Fine Motor Skills (pinching, gripping, etc) (Frequently)
• Physical Requirement - Hearing (Frequently)
• Physical Requirement - Pushing/pulling (Occasionally)
• Physical Requirement - Reaching (Occasionally)
• Physical Requirement - Sitting (Frequently)
• Physical Requirement - Standing (Frequently)
• Physical Requirement - Stooping/crouching/kneeling/crawling (Occasionally)
• Physical Requirement - Talking (Frequently)
• Physical Requirement - Tasting/smelling (Occasionally)
• Physical Requirement - Walking (Frequently)
• Physical Requirement - Near Vision (Constantly)
• Physical Requirement - Color Discrimination (Occasionally)
• Physical Requirement - Use of keyboard, mouse and/or computer equipment (Constantly)
• Physical Requirement - Lift up to 35 pounds without assistance (Occasionally)
• Occupational Exposure/Risk Potential - Inside office environment (Applicable)
• Occupational Exposure/Risk Potential - Airborne communicable diseases (Applicable)
• Occupational Exposure/Risk Potential – Blood-borne pathogens or bodily fluid (Applicable)
• Occupational Exposure/Risk Potential - Fumes or airborne particles (Applicable)

Full-time position – 40 hours. Work days: Monday through Thursday, Hours: 7:00 am – 5:00 pm. Salary commensurate with experience.

Oregon Medical Research Center is an equal-opportunity employer.

Job Type: Full-time

Pay: $26.00 - $39.00 per hour

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Health savings account
• Paid time off
• Vision insurance

Application Question(s):

• This position is in-person in Portland, OR. Are you able to reliably commute into the office for this job?

Language:

• Spanish (Preferred)

Work Location: In person