Experienced CRA II/Sr CRA – Multiple Therapeutic Areas

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

📋 Description

• Execute and coordinate clinical monitoring and site management tasks.

• Carry out both remote and on-site visits to evaluate compliance with protocols and regulations.

• Oversee sponsor procedures, guidelines, and monitoring environments.

• Ensure clinical trials adhere to approved protocols, ICH-GCP guidelines, regulatory requirements, and SOPs.

• Monitor investigator sites utilizing a risk-based monitoring strategy.

• Employ root cause analysis, critical thinking, and problem-solving techniques to identify failures in site processes and implement corrective or preventive measures.

• Guarantee data accuracy through the review of source documents, source data verification, and CRF assessments.

• Evaluate the inventory and records of the investigational product.

• Document findings in reports and correspondence, and escalate any deficiencies until resolved.

• Maintain communication with investigative sites between monitoring visits.

• Engage in investigator payment processes and resolution of findings.

• Take part in investigator meetings and identify potential investigators.

• Initiate clinical trial sites and provide recommendations regarding site compliance.

• Conduct trial closeout activities and retrieve trial materials.

• Ensure all essential documents are complete and perform on-site file reviews.

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

• Update study systems, including Clinical Trial Management Systems.

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

• Respond to company, client, and regulatory requirements, including audits and inspections.

• Complete expense reports and timesheets.

• Assist with project publications and tools.

• Contribute to project initiatives and process enhancements.

⛳️ Requirements

• Bachelor's degree in a life sciences-related field, or a Registered Nursing certification or equivalent relevant formal academic/vocational qualification.

• Prior experience equivalent to 1 year as a clinical research monitor, or completion of the PPD Drug Development Fellowship.

• A valid driver's license where applicable.

• Equivalency may be achieved through a combination of relevant education, training, and/or closely related experience.

• Demonstrated clinical monitoring skills.

• 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.

• Customer-focused with strong listening abilities, attention to detail, and the capacity to identify underlying issues.

• Excellent organizational and time management skills.

• Strong interpersonal skills.

• Flexibility and adaptability in various situations.

• Ability to work effectively in a team or independently.

• Proficient in Microsoft Office and quick to learn relevant software.

• Good command of the English language and grammar.

• Presentation skills are essential.

• Willingness to travel frequently, typically 60–80%, including potential extended overnight stays.

• Capability to operate in office, laboratory, clinical, and/or home office environments.

• Ability to utilize required personal protective equipment.

🏝️ Benefits

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

• Selection of national medical and dental plans, along with a national vision plan.

• Health incentive programs available.

• Employee assistance and family support initiatives.

• Commuter benefits offered.

• Tuition reimbursement program.

• 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).

• Coverage for accident and life insurance.

• Short- and long-term disability plans.

• Participation in a 401(k) U.S. retirement savings plan.

• Employees’ Stock Purchase Plan (ESPP) with a discount on company stock.