Assistant CRA – Northeast, Southeast US

This is a fully remote position, open to applicants in New Jersey, +3 more states.

📋 Description

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

• Complete and record study-specific training while becoming familiar with study-specific systems.

• Offer internal support during pre-study assessments and waivers.

• Tailor site ICFs with the necessary site contact information.

• Conduct remote EMR/EHR checklist reviews and assist in assessments.

• Confirm the collection of documents and the status of RCR submissions; refresh site EDL and site details.

• Evaluate patient-facing materials and their translations.

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

• Ensure proper access to systems is requested, authorized, and revoked for relevant site staff.

• Follow up with site staff regarding training progress.

• Organize logistics for IM attendance and oversee vendor tracking.

• Manage study/site supply logistics.

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

• Pursue any missing vendor data, such as ECGs, lab samples, and e-diaries.

• Facilitate ongoing remote evaluations of centralized monitoring tools.

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

• Carry out reconciliation tasks for CRF and query status, deviations, SAEs, and safety reports.

• Verify the status of document collection and prompt actions for missing, incomplete, expired, or outstanding documents.

• Execute additional assigned site management tasks and client-requested FSP role profiles.

• Fulfill administrative duties such as expense reports and timesheets.

⛳️ Requirements

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

• Prior experience providing skills and abilities comparable to 0–2 years.

• At least 6 months of exposure to clinical trials/clinical research is preferred.

• Candidates must reside within 60 miles of a major airport due to anticipated travel requirements.

• Fundamental knowledge of medical/therapeutic areas and medical terminology.

• Familiarity with ICH GCP, relevant regulations, and company procedural documents.

• Strong oral and written communication abilities.

• Excellent interpersonal and customer service capabilities.

• Solid organizational and time management skills, along with a keen attention to detail.

• Capacity to manage multiple tasks efficiently and effectively.

• Flexibility and adaptability in a dynamic work environment.

• Ability to collaborate in a team or work independently.

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

• Proficient in computer skills with a good command of MS Office.

• Capability to learn and utilize relevant software and embrace modern technology.

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

• Exceptional English language and grammar proficiency.

🏝️ Benefits

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

• National medical and dental insurance plans.

• National vision insurance plan.

• Health incentive programs.

• Employee assistance and family support programs.

• Commuter benefits.

• Tuition reimbursement.

• 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 insurance.

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

• Employees’ Stock Purchase Plan (ESPP) allowing the purchase of company stock at a discount.

• Fully remote work arrangement.