Clinical Research Associate - Software Guidance & Assistance
Boston, MA
About the Job
Software Guidance & Assistance, Inc., (SGA), is searching for a Clinical Research Associate for a CONTRACT assignment with one of our premier Healthcare clients. This position is fully remote.
Responsibilities:
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.
Responsibilities:
- Ability to prioritize workload and manage multiple protocols
- Contribute to the identification of new sites for clinical trials
- Implement complete site management including monitoring visits and regulatory assessment
- Resolve technical and content issues to achieve timely database lock targets
- Negotiate investigator remuneration and prepare financial contracts
- Implement site close-out activities and generate site close-out report
- Verify adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff;
- Responsible for medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements;
- Must have 3+ years experience as a CRA from either a pharmaceutical or CRO background
- Minimum 3 years prior monitoring experience with global trials
- Minimum 2 years experience with direct interim monitoring experience including SDV (Source Document Verification), SDR (Source Data Review) and MRR (Medical Record Review) with respect to eligibility (in/ex) criteria. and preferably in a remote environment
- Must have an In-depth knowledge of FDA regulations and ICH/GCP guidelines
- Must be familiar and adept with managing fully decentralized studies
- Must be willing/able to travel 20% requiring travel to the CRO location to the extent on-site SDV is required. Travel will NOT be reimbursed. The only travel may be to perform quarterly drug accountability at the central receiving site
- CCRA or SOCRA certified - highly preferred
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.
Source : Software Guidance & Assistance