Senior CRA I – Multiple Therapies

This is a fully remote position, open to applicants in Connecticut, +7 more states.

📋 Description

• Serve as a representative for a specific client within the FSP model

• Oversee and coordinate all elements of clinical monitoring and site management

• Execute both remote and on-site visits to evaluate protocol and regulatory compliance

• Manage essential documentation and maintain audit readiness

• Monitor investigator sites employing a risk-based monitoring strategy

• Utilize root cause analysis, critical thinking, and problem-solving skills to identify site process failures and implement corrective/preventive actions

• Ensure data precision by reviewing source documents, verifying source data, and assessing CRFs

• Evaluate investigational products through physical inventory checks and record reviews

• Record observations in reports and letters adhering to approved business writing standards

• Report deficiencies and issues to clinical management and oversee their resolution

• Maintain consistent communication with investigative sites between monitoring visits

• Execute monitoring tasks as outlined in the approved monitoring plan

• Engage in investigator payment processes and participate in investigator meetings

• Track trial status and relay progress updates to the Clinical Team Manager

• Update clinical trial management systems and conduct QC checks on CTMS-generated reports

• Identify potential investigators and initiate clinical trial sites

• Ensure trial closeout, retrieval of trial materials, and completion of necessary documents

• Conduct on-site file reviews

• Contribute to project publications, tools, process enhancements, and other project initiatives

• Facilitate communication among investigative sites, the client company, and project teams

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

• Complete administrative duties such as expense reports and timesheets

⛳️ Requirements

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

• Prior experience providing the knowledge, skills, and abilities necessary for the role, typically equivalent to 3+ years

• Oncology experience is preferred

• Strong critical thinking and problem-solving abilities

• Excellent skills in monitoring clinical trials, both remotely and on-site

• Proven understanding of ICH-GCP guidelines, applicable regulations, and SOPs

• Strong communication and collaboration capabilities

• Advanced proficiency in both written and verbal communication

• Strong organizational skills with a keen attention to detail

• Demonstrated experience with computer systems, including CTMS and other trial management platforms

• Willingness to travel over 75% as necessary for site monitoring activities

🏝️ Benefits

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

• Programs for employee assistance and family support, including commuter benefits and tuition reimbursement

• A minimum of 120 hours 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 in accordance with company policy

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

• Employees’ Stock Purchase Plan (ESPP), allowing eligible colleagues to purchase company stock at a discounted rate

• Eligibility for a variable annual bonus based on company, team, and/or individual performance

• Health incentive programs