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About the Role

Join our global team as a Senior Clinical Research Associate (Level I/II) and play a vital role in supporting pharmaceutical and biotech companies. You will coordinate and perform all aspects of clinical monitoring and site management, ensuring protocol compliance, regulatory adherence, and data reliability.

Responsibilities

Perform and coordinate all aspects of the clinical monitoring and site management process.
Conduct remote or on-site visits to assess protocol and regulatory compliance.
Manage required documentation.
Manage procedures and guidelines from different sponsors and/or monitoring environments.
Ensure trial conduct aligns with approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs.
Guarantee subjects' rights, well-being, and data reliability.
Ensure audit readiness and develop collaborative relationships with investigational sites.
Monitor investigator sites using a risk-based monitoring approach.
Apply root cause analysis (RCA), critical thinking, and problem-solving skills to identify site process failures and implement corrective/preventive actions.
Ensure data accuracy through SDR, SDV, and CRF review.
Assess investigational product through physical inventory and records review.
Document observations in reports and letters in a timely manner.
Escalate observed deficiencies and issues to clinical management and follow through to resolution.
Maintain regular contact with investigative sites to confirm protocol adherence and issue resolution.
Conduct monitoring tasks in accordance with the approved monitoring plan.
Participate in the investigator payment process.
Ensure shared responsibility with project team members on issue/finding resolution.
Investigate and follow-up on findings.
Provide trial status tracking and progress update reports to the Clinical Team Manager (CTM).
Ensure study systems are updated per agreed study conventions.
Perform QC checks of reports generated from CTMS system.
Participate in investigator meetings.
Identify potential investigators in collaboration with the client company.
Initiate clinical trial sites according to relevant procedures.
Ensure trial close out and retrieval of trial materials.
Ensure required essential documents are complete and in place.
Conduct on-site file reviews as per project specifications.
Assist in the preparation of project publications/tools.
Share ideas/suggestions with team members.
Perform additional study tasks as assigned by CTM.
Facilitate effective communication between investigative sites, the client company, and the project team.
Respond to company, client, and applicable regulatory requirements/audits/inspections.
Maintain and complete administrative tasks such as expense reports and timesheets.
Contribute to other project work and initiatives for process improvement.

Requirements

Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
Previous experience comparable to 2+ years as a clinical research monitor.
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.
Experience in either Medical Devices OR Oncology.

Skills

Effective clinical monitoring skills
Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
Excellent understanding and demonstrated application of ICH GCPs, applicable regulations and procedural documents
Well-developed critical thinking skills
Ability to manage Risk Based Monitoring concepts and processes
Effective oral and written communication skills
Ability to maintain customer focus
Effective interpersonal skills
Strong attention to detail
Effective organizational and time management skills
Ability to remain flexible and adaptable
Ability to work in a team or independently
Good computer skills: proficient knowledge of Microsoft Office and ability to learn appropriate software
Good English language and grammar skills
Good presentation skills

Location

Office

Work Type

Standard (Mon-Fri)
Office
Frequent travel, generally 60-80%
Extended overnight stays

Experience Level

Senior

Education Level

Bachelor's degree in a life sciences related field
Registered Nursing certification

Salary/Compensations

$88,600.00–$144,900.00
Variable annual bonus based on company, team, and/or individual performance results

Benefits

Choice of national medical and dental plans, and a national vision plan, including health incentive programs
Employee assistance and family support programs, including commuter benefits and tuition reimbursement
At least 120 hours paid time off (PTO)
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)

About the Company

Successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.