FSP Clinical Research Associate II – Multiple Therapies

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

📋 Description

• Execute and coordinate clinical monitoring and site management tasks.

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

• Oversee documentation and procedures within sponsor and monitoring environments.

• Ensure that trials adhere to approved protocols, ICH-GCP guidelines, regulations, and SOPs.

• Maintain audit readiness and foster collaborative relationships with investigational sites.

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

• Employ root cause analysis and problem-solving techniques to pinpoint process failures and establish corrective/preventive actions.

• Guarantee data accuracy through SDR, SDV, and CRF reviews.

• Evaluate investigational products via inventory and record assessments.

• Document findings in reports and letters, escalate deficiencies, and track issues until resolution.

• Keep in touch with investigative sites between monitoring visits.

• Perform monitoring activities according to the approved monitoring plan.

• Engage in investigator payment processes and attend investigator meetings.

• Identify potential investigators and initiate clinical trial sites.

• Conduct trial closeout processes and retrieve trial materials.

• Ensure essential documents are complete and compliant.

• Carry out on-site file reviews.

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

• Update study systems, including the Clinical Trial Management System (CTMS).

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

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

• Complete expense reports, timesheets, and other administrative responsibilities.

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

⛳️ Requirements

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

• Minimum of 1 year of experience as a clinical research monitor or similar experience.

• Valid driver's license where applicable.

• Demonstrated clinical monitoring abilities.

• Knowledge of medical/therapeutic areas and medical terminology.

• Proficient understanding of ICH GCPs, relevant regulations, and procedural documents.

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

• Capability to manage Risk Based Monitoring concepts and processes.

• Effective oral and written communication skills, including interactions with medical personnel.

• Customer-focused with excellent listening skills and attention to detail.

• Strong organizational and time management abilities.

• Good interpersonal skills.

• Adaptability and flexibility.

• Ability to work independently as well as collaboratively in a team setting.

• Proficiency in Microsoft Office and ability to learn relevant software.

• Strong English language and grammar skills.

• Presentation skills.

• Willingness to travel frequently, typically 60–80%, with the role requiring travel over 75% of the time.

• Ability to adhere to specific sponsor/client/site requirements.

• Capacity to work in an upright or stationary position for 6–8 hours each day.

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

• Consistent and regular attendance.

• Ability to perform under stress and manage multiple tasks simultaneously.

🏝️ Benefits

• A selection of national medical and dental plans, along with a national vision plan, including health incentive programs.

• Employee assistance and family support programs.

• Commuter benefits.

• Tuition reimbursement.

• 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.

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

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

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

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