About the role

Monitor investigator sites with a risk-based monitoring approach, applying root cause analysis, critical thinking and problem-solving to identify and correct site process failures
Ensure data accuracy through SDR, SDV and CRF review via on-site and remote monitoring activities
Assess investigational products through physical inventory and records review
Document observations in reports and letters in a timely manner using approved business writing standards
Escalate observed deficiencies and issues to clinical management and follow through to resolution
Maintain regular contact with investigative sites between monitoring visits as needed
Conduct monitoring tasks in accordance with the approved monitoring plan
Participate in the investigator payment process and shared issue resolution with project team members
Investigate and follow-up on findings; participate in investigator meetings as necessary
Identify potential investigators in collaboration with the client to ensure qualified investigative sites
Initiate clinical trial sites according to procedures to ensure protocol, regulatory and ICH GCP compliance
Perform trial close out and retrieval of trial materials; ensure essential documents are complete per ICH-GCP and applicable regulations
Conduct on-site file reviews per project specifications and provide trial status tracking and progress updates to the Clinical Team Manager (CTM)
Ensure study systems are updated per agreed study conventions and facilitate effective communication between investigative sites, the client company and the PPD project team
Respond to company, client and regulatory requirements/audits/inspections and maintain administrative tasks such as expense reports and timesheets
Contribute to project publications/tools, process improvement initiatives and other project work as required
Progressive and/or more extensive job duties expected with increasing CRA level

Requirements

Bachelor's degree in a life science related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification
Therapeutic Experience Required: Renal, Transplant and/or Nephrology
CRA (Level II): comparable to 1+ years as a clinical research monitor
Sr CRA (Level I): comparable to 2+ years as a clinical research monitor
Sr CRA (Level II): comparable to 3+ years as a clinical research monitor
Principal CRA: comparable to 5+ years clinical research monitoring experience
Valid driver's license where applicable
In some cases, an equivalency consisting of a combination of appropriate education, training and/or directly related experience will be considered sufficient
Proven clinical monitoring skills
Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
Demonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documents
Well-developed critical thinking skills, including root cause analysis (RCA) and problem solving
Ability to manage Risk Based Monitoring concepts and processes
Good oral and written communication skills
Ability to maintain customer focus, good listening skills and attention to detail
Good organizational and time management skills
Effective interpersonal skills and ability to remain flexible and adaptable
Ability to work in a team or independently as required
Good computer skills: solid knowledge of Microsoft Office and ability to learn appropriate software
Good English language and grammar skills
Good presentation skills
Frequent travel, generally 60-80%

Benefits

Competitive remuneration
Annual incentive plan bonus (variable annual bonus)
Healthcare: A choice of national medical and dental plans, and a national vision plan, including health incentive programs
Employee assistance and family support programs
Commuter benefits
Tuition reimbursement
At least 120 hours paid time off (PTO) and 10 paid holidays annually
Paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave)
Accident and life insurance
Short- and long-term disability
Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
Employees’ Stock Purchase Plan (ESPP)
Comprehensive Total Rewards package, career and development prospects

Hybrid Clinical Research Associate II / Senior / Principal – Renal, Transplant, Nephrology

About the role

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