Assistant CRA – Northeast/Southeast

This is a fully remote position, open to applicants in California.

📋 Description

• Conduct remote tasks on assigned projects in collaboration with the CRA and Clinical Lead for the study.

• Facilitate site readiness and oversee logistical monitoring processes.

• Assist with site management and remote monitoring in accordance with SOPs and regulatory standards.

• Engage in limited site contact tasks during study initiation, management, recruitment, and closure.

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

• Complete training and orientation specific to the study systems.

• Provide internal support for pre-study evaluations and waivers.

• Personalize site ICFs with relevant site contact information.

• Review EMR/EHR checklists from a remote location.

• Confirm document collection, RCR submission status, site EDL, and site details.

• Examine patient-facing materials and their translations.

• Assist in vendor qualification, system access, site staff training, IM attendance, vendor trackers, and study/site supplies.

• Aid in the collection, review, and updating of essential documents.

• Follow up on outstanding vendor information, including ECGs, lab samples, and e-diaries.

• Support remote evaluation of centralized monitoring tools.

• Assist with site payment processes, system updates, reconciliations, and invoice follow-ups.

• Conduct trial reconciliations regarding CRF/query status, deviations, SAEs, and safety reports.

• Take initiative on missing, incomplete, expired, or open documents.

• Perform administrative duties such as preparing expense reports and timesheets.

⛳️ Requirements

• Bachelor's degree in a life science discipline or a related field, or Registered Nursing certification, or an equivalent formal academic/vocational qualification.

• Prior experience ranging from 0 to 2 years is preferred.

• Equivalent experience may include appropriate education, training, and/or directly related work experience.

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

• Familiarity with ICH GCP, applicable regulations, and company procedural documentation.

• Competent computer skills with a strong knowledge of MS Office.

• Capacity to learn and utilize relevant software effectively.

• Ability to extract data from study documents, electronic study data systems, CTMS, and dashboards.

• Excellent proficiency in English language and grammar.

• Strong ability to manage multiple tasks efficiently and effectively.

• Occasional travel to clinics or hospitals may be necessary.

🏝️ Benefits

• Variable annual bonus based on company, team, and/or individual performance.

• National medical and dental plans.

• National vision plan.

• Health incentive programs.

• Employee assistance and family support programs.

• Commuter benefits.

• Tuition reimbursement.

• At least 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.

• Short- and long-term disability coverage.

• 401(k) U.S. retirement savings plan.

• Employees’ Stock Purchase Plan (ESPP) offering discounted company stock.

• Fully remote work arrangement.