Research Compliance Analyst

Software Guidance & Assistance, Inc., (SGA), is searching for a Research Compliance Analyst for a Contract assignment with one of our premier Healthcare clients in Los Angeles, CA .

Responsibilities :

• Applies research compliance professional concepts to review research protocols to ensure that all regulatory criteria are met as well as policies and / or regulations from the organization, the state and systemwide.
• Under general supervision, participates in pre-review and follow-up of full board committee protocols.
• Determines the appropriate level of review in triage.
• Under general supervision, issues formal communications to funding agencies and other regulatory organization units.
• Communicates with researchers and provides guidance on how to resolve particular issues of concern and meet requirements of external regulatory bodies and to properly document these actions in accordance with all applicable laws, regulations, policies and procedures.
• Generates and analyzes reports of review and approval activities.
• Communicates directly with investigators to resolve all concerns as identified during the review process.
• Participates in training of individuals and departments on relevant compliance processes, forms and policies.
• Participates in the development and revision of standard operating procedures and guidelines.

Required Skills:

• Bachelor's Degree with 2+ years of Clinical Research Regulatory experience
• Working knowledge of regulatory documents (DOA, financial disclosures, 1572s, inform consent documents, etc.)
• Experience submitting to local and external IRBs
• Experience working with industry sponsors and handling monitor visits
• Bachelor's degree in related area and / or equivalent experience / training
• Independence, planning and decision-making abilities to complete assigned duties
• Knowledge of relevant Federal and State regulations, and policies
• Ability to solve problems, issues; listen, interpret and confirm understanding of others' communications; and be objective
• Effective, efficient and tactful oral and written communication skills
• Time management skills and the flexibility to accommodate changing priorities in unit
• Ability to work in a team oriented setting, to prioritize work, and to follow through on routine assignments with minimal direction
• Proficiency with computers, including the ability to operate personal computer software with sophisticated retrieval, storage, and merging capabilities
• Excellent customer service skills, pleasant, helpful and patient

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 .

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 to request an accommodation or assistance regarding our policy.