Clinical Research Associate II – Multiple Therapies

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

📋 Description

• Execute and coordinate clinical monitoring as well as site management activities.

• Perform remote or on-site visits to evaluate compliance with protocols and regulations.

• Oversee necessary documentation to ensure readiness for audits.

• Utilize a risk-based monitoring strategy to oversee investigator sites.

• Employ root cause analysis, critical thinking, and problem-solving techniques to address site process failures.

• Ensure the accuracy of data through SDR, SDV, and CRF evaluations.

• Evaluate the inventory and documentation of investigational products.

• Record observations in reports and letters, escalating any deficiencies until resolved.

• Maintain communication with investigative sites between monitoring visits.

• Execute monitoring responsibilities following the approved monitoring plan.

• Take part in processes related to investigator payments and meetings.

• Identify and initiate relationships with qualified clinical trial sites.

• Conduct trial closeout procedures and retrieve trial materials.

• Ensure that essential documents are complete as per ICH-GCP and relevant regulations.

• Conduct on-site file evaluations.

• Provide updates on trial status and progress to the Clinical Team Manager.

• Update study systems, including CTMS.

• Facilitate communication among sites, the client company, and the PPD project team.

• Address company, client, and regulatory requirements, including audits and inspections.

• Complete expense reports and timesheets.

• Assist in project publications/tools and contribute to process improvement initiatives.

⛳️ Requirements

• Bachelor’s degree in a life sciences field or a Registered Nursing certification, or equivalent academic/vocational qualification.

• At least 1 year of relevant experience as a clinical research monitor.

• Valid driver’s license where applicable.

• Demonstrated clinical monitoring capabilities.

• Knowledge of medical/therapeutic areas and medical terminology.

• Familiarity with ICH GCPs, applicable regulations, and procedural documents.

• Strong critical thinking, root cause analysis, and problem-solving abilities.

• Capability to manage Risk-Based Monitoring concepts and processes.

• Proficient oral and written communication skills for interaction with medical personnel.

• Customer-focused attitude, listening skills, attention to detail, and the ability to identify underlying issues.

• Strong organizational and time management skills.

• Ability to work independently or as part of a team.

• Proficiency in Microsoft Office and aptitude for learning relevant software.

• Good command of the English language and grammar.

• Effective presentation skills.

• Willingness to travel frequently, typically 60–80%, with travel exceeding 75% required.

• Ability to meet sponsor/client/site requirements, including possible vaccination-status disclosure.

• Capacity to work upright and/or stationary for 6–8 hours per day.

• Ability to lift and carry weights up to 15–20 lbs.

• Regular and consistent attendance is essential.

🏝️ Benefits

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

• National medical and dental insurance plans.

• National vision plan, inclusive of health incentive programs.

• Employee assistance and family support services.

• Commuter benefits.

• Tuition reimbursement opportunities.

• 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.

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

• Employee Stock Purchase Plan (ESPP) offering discounted company stock purchase opportunities.