Assistant CRA, West & Central US

This is a fully remote position, open to applicants in Arizona, +4 more states.

📋 Description

• Execute study and site management tasks as outlined in the task matrix.

• Complete and document training specific to the study.

• Provide orientation and training on systems related to the study.

• Offer in-house support during pre-study assessments and waivers.

• Assist in the customization of Site Informed Consent Forms (ICFs) with site contact details.

• Conduct remote reviews of Electronic Medical Records (EMR) and Electronic Health Records (EHR) checklists.

• Confirm document collection and the status of Regulatory and Compliance Report (RCR) submissions; update site Essential Document List (EDL) and site information.

• Review materials intended for patients and their translations.

• Assist in vendor-related qualification processes for site personnel.

• Ensure that system access is requested, granted, and revoked for pertinent site staff.

• Follow up on training for site staff.

• Organize logistics for Investigator Meetings (IM) attendance.

• Maintain trackers for vendors.

• Manage study and site supply coordination.

• Support the collection, reviewing, and updating of Essential Documents within systems.

• Follow up on any missing study vendor data such as ECGs, lab samples, and electronic diaries.

• Aid in the ongoing remote review of centralized monitoring tools.

• Support site payment processes, system updates, reconciliations, and follow-up on invoices.

• Carry out reconciliation tasks on assigned trials, which include tracking Case Report Form (CRF) and query status, deviations, Serious Adverse Events (SAEs), and safety reports.

• Verify the status of document collection and take action on missing, incomplete, expired, or open documents.

• Execute other assigned site management responsibilities.

• Manage administrative tasks such as preparing expense reports and timesheets.

⛳️ Requirements

• A completed Bachelor's degree in a life science field or a related area, or a Registered Nursing certification, or equivalent relevant academic/vocational qualification.

• Prior experience ranging from 0 to 2 years; combinations of education, training, and directly related experience may also be considered.

• Preferably at least 6 months of exposure to clinical trials or clinical research.

• Must reside within 60 miles of a major airport.

• Basic understanding of medical or therapeutic areas and medical terminology.

• Working knowledge of ICH Good Clinical Practice (GCP), applicable regulations, and company procedural documents, or the ability to acquire and maintain such knowledge.

• Strong oral and written communication skills.

• Exceptional interpersonal and customer service abilities.

• Good organizational and time management skills with a keen attention to detail.

• Capability to manage multiple tasks efficiently and effectively.

• Flexibility and adaptability to changing situations.

• Ability to work independently as well as collaboratively within a team.

• Well-honed critical thinking, root cause analysis, and problem-solving skills.

• Proficient computer skills with a solid understanding of MS Office.

• Capacity to learn and utilize relevant software and extract information from study documents, electronic study data systems, Clinical Trial Management Systems (CTMS), and dashboards.

• Excellent proficiency in English language and grammar.

🏝️ Benefits

• Variable annual bonus based on performance results at the company, team, and/or individual level.

• Selection of national medical and dental insurance plans.

• National vision plan, including health incentive programs.

• Employee assistance and family support initiatives.

• Commuter benefits.

• Tuition reimbursement options.

• A minimum of 120 hours of paid time off (PTO).

• 10 paid holidays each year.

• Paid parental leave: 3 weeks for bonding and 8 weeks for caregiver leave.

• Accident and life insurance coverage.

• Short- and long-term disability benefits in accordance with company policy.

• Competitive 401(k) retirement savings plan in the U.S.

• Employee Stock Purchase Plan (ESPP), allowing eligible colleagues to purchase company stock at a discounted rate.

• Fully remote work arrangement.