Temporary Clinical Research Associate
Manager: Sr. Manager, Clinical Oversight and Optimization
Department: Clinical Operations
Sangamo Therapeutics is a genomic medicine company building value with cutting-edge work across four distinct but complementary technology platforms – gene therapy, cell therapy, in vivo genome editing, and in vivo genome regulation. At Sangamo, we are passionate in developing genomic medicines to transform the lives of patients with serious diseases. We transform lives by building a robust, sustainable, differentiated, innovative, and high value genomic medicine pipeline that addresses patients with life-limiting conditions. Sangamo takes pride in being the first to edit endogenous human genes, first to treat patients with gene edited T cells, and first to treat patients with in vivo genome editing. Our top priority is to meet the needs of patients with commitment and compassion. Sangamo is a company where individuals can flourish, grow and develop their expertise.
We are seeking top talent to join our mission. Let’s build a better future together.
The Temporary Clinical Research Associate will support the Clinical Operations department with implementation of sponsor oversight initiatives, inspection readiness, and oversight of eTMF quality in accordance with study plans, Sangamo SOPs, and applicable regulatory requirements and guidelines.
- Ensure assigned aspects of clinical studies are managed and executed in accordance with ICH GCP, regulations, the protocol, and company SOPs.
- As assigned, assist study teams with the development and/or review of study specific plans or study level documents by providing sponsor oversight perspective.
- Perform routine periodic eTMF quality/inspection readiness checks of both in-house eTMFs and CRO managed eTMFs including completeness checks, logic checks, and document quality checks. Document, escalate and track deficiencies and assist as needed with resolution.
- As requested, work with study teams to assist with study risk assessments, identifying Key Risk Indicators (KRIs), and developing and tracking mitigation strategies.
- Perform periodic reviews of study-level and program-level KRI metrics, collate the data output and escalate key information to study teams as appropriate in a timely manner.
- Perform on-site and/or remote Sponsor Oversight Visits to assess CRA and site performance.
- Assist with the development of department level procedures, processes, templates, and tools.
- May conduct Veeva eTMF training for internal and CRO study staff as requested.
- Other duties as assigned.
EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:
- Bachelor’s degree in a scientific discipline or RN
- At least 2 years of clinical research experience (Sponsor experience a plus)
- Knowledge of pharmaceutical regulatory requirements
- Knowledge of ICH GCP guidelines and clinical study regulations
- Understands the concept of clinical study design and clinical study processes.
- Prior site experience (e.g., study coordinator) and/or field monitoring experience
- Prior experience with Veeva eTMF is preferred.
- Prior experience with CTMS implementation and use is a plus.
- Requires little instruction on routine work and general instruction on new assignments.
- Ability to multi-task and prioritize time to complete assigned work.
- Self-motivated, high attention to detail, and able to function independently or as part of a team.
- Effective communication and organizational skills
- Able to travel up to 25% with potential for international travel.
- Candidate can be remotely located anywhere in the United States
Sangamo is an equal opportunity employer
The above reflects management’s definition of essential functions for this position but does not restrict the tasks that may be assigned. The above duties are representative only; management may assign or reassign duties and responsibilities to this position at any time.