Job Description
Responsibilities :
- Coordinate research studies, identify participants according the IRB approved recruitment plan and assist the PI with determining patient eligibility.
- Facilitate the informed consent process, communicate protocol requirements to the participant, provide participant education related to protocol requirements and the significance of protocol compliance.
- Manages patient registration, data and treatment assignment
- Facilitate the safe and accurate completion of protocol required procedures in accordance with FDA CFR, GCP, and institutional best practice.
- Maintain ultrasound machines, troubleshooting with service providers, and keeping the machines clean. Assist in labeling of musculoskeletal ultrasound images and storage of images
- Manage all patient data within the EDC system (entry, queues, maintenance, and etc.)
- Maintain regulatory and patient binders
- Work with the fund manager and purchaser on patient visit reimbursements and sponsor invoicing.
- Obtain medical and treatment records from outside sources as necessary.
- Working hours - 8a-5p(M-F), On-site ONLY.
- Bachelors Degree or 1-3 years of previous study coordination or Clinical Research coordination experience
- Strong verbal and written communication skills along with strong interpersonal skills to effectively establish rapport, and build collaborative relationships.
- Ability to handle confidential material information with judgement and discretion
- Strong organizational capabilities to organize multiple projects and competing deadlines for efficiency and cost-effectiveness.
- Ability to be flexible in handling work delegated by more than one individual
- Typing and computer skill/ability including word-processing, use of spreadsheets, email, data entry. Ability to navigate numerous software programs and applications
Preferred Skills:
- Working knowledge of the Clinical Research regulatory framework and institutional requirements.
- Mathematical skills Sufficient to prepare Clinical Research budgets, knowledge of math ability and knowledge of clinical trials research budgeting process to assist with the preparation of clinical trial budgets.
- Working knowledge of FDA Code of Federal Regulations (CFR) and ICH Good Clinical Practice (GC) for Clinical Research
SGA is a technology and resource solutions provider driven to stand out. We are a women-owned business. Our mission: to solve big IT problems with a more personal, boutique approach. Each year, we match consultants like you to more than 1,000 engagements. When we say let's work better together, we mean it. You'll join a diverse team built on these core values: customer service, employee development, and quality and integrity in everything we do. Be yourself, love what you do and find your passion at work. Please find us at https://sgainc.com/ .
SGA is an Equal Opportunity Employer and does not discriminate on the basis of Race, Color, Sex, Sexual Orientation, Gender Identity, Religion, National Origin, Disability, Veteran Status, Age, Marital Status, Pregnancy, Genetic Information, or Other Legally Protected Status. We are committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, and our services, programs, and activities. Please visit our company EEO page to request an accommodation or assistance regarding our policy.