Clinical Research Associate/Clinical Research Monitor

Competencies Required:

• Excellent oral and written communication skills

• Strong interpersonal and relationship-building skills with investigators and site staff

• Ability to work independently with a high degree of accountability

• Ability to travel up to 10% of the time for meetings and on-site monitoring visits

• Ability to identify operational, regulatory, or quality risks and develop strategic, solution-oriented recommendations

• Exceptional attention to detail and strong organizational skills

• Proficiency navigating and utilizing multiple online systems and software platforms

• Advanced knowledge of ICH-GCP guidelines, federal regulations, and human subjects protections

• Ability to analyze performance metrics and develop and implement risk-based quality management strategies

Primary Duties:

• Conduct site monitoring visits (including Site Qualification Visits, Site Initiation Visits, Monitoring Visits, and Close-Out Visits) in accordance with the approved monitoring plan.

• Exercise partial ownership of the study's quality oversight framework by evaluating the effectiveness of the existing monitoring plan and recommending strategic revisions based on study phase, enrollment status, retention priorities, protocol amendments, monitoring findings, and site performance trends.

• Collaborate with study leadership to implement adaptive monitoring approaches, including modifications to visit frequency, scope of review, central versus on-site monitoring balance, and targeted risk mitigation strategies.

• Assess site compliance with the study protocol, informed consent requirements, IRB approvals, and regulatory obligations, ensuring protection of participant rights and safety.

• Perform source data verification and source document review to ensure that data entered into electronic case report forms (eCRFs) are accurate, complete, and verifiable from source documentation.

• Identify systemic data quality trends or recurring compliance issues and provide recommendations for corrective and preventive actions (CAPA) at both the site and study-wide levels.

• Review and assess essential regulatory documents, including IRB documentation, delegation logs, training logs, and protocol deviation logs

• Ensure timely resolution of data queries and protocol deviations in collaboration with site personnel and the Coordinating Center.

• Provide study-specific training to investigators and site staff throughout the study lifecycle, reinforcing protocol adherence and regulatory best practices.

• Maintain regular communication with sites to support enrollment, data quality, retention efforts, and adherence to study procedures.

• Document monitoring activities, findings, and follow-up actions through detailed monitoring reports and formal correspondence within established timelines.

• Report significant findings, trends, or compliance concerns to study leadership and contribute to action planning discussions.

• Participate in weekly study team meetings and actively contribute to discussions regarding site performance metrics, quality indicators, and strategic oversight planning.

Other Tasks, as required:

• Participate in site and/or investigator selection processes, providing input regarding site readiness and risk profile.

• Contribute to the development and refinement of monitoring tools, risk assessment frameworks, tracking systems, and quality improvement initiatives.

• Perform central monitoring activities, including analysis of recruitment trends, retention metrics, protocol deviation patterns, and data quality dashboards.

• Support preparation for sponsor reviews or regulatory inspections, including documentation review and corrective action planning.

• Attend and participate in investigator meetings, coordinator meetings, and study training sessions as needed.

• Submit monitoring visit expense reports and administrative documentation in a timely manner.

Education

• BA or BS required. Clinical research professional certification preferred (e.g., ACRP, SOCRA).

Experience

• Minimum of 2 years of experience in clinical research; 3-5 years preferred with a minimum of 1 year of monitoring experience.

• Experience in multi-center clinical trials and/or stroke, neurology, or outcomes research preferred.

• Demonstrated knowledge of ICH-GCP guidelines, federal regulations, and human subjects protections.

• Experience contributing to risk-based monitoring strategies or quality oversight initiatives preferred.

• Proficiency with Microsoft Office applications and clinical research data management systems.

• Demonstrated ability to manage monitoring responsibilities across multiple sites.

Knowledge, Skills and Abilities
- Ability to work independently and as a team member.
- Strong attention to detail and organizational skills.
- Knowledge of clinical research protocols.
- Knowledge of data management programs.
- Computer literacy.
- Knowledge of clinical trials, research, and general medicine.

Physical Requirements

• Standing Frequently (34-66%)
• Walking Frequently (34-66%)
• Sitting Occasionally (3-33%)
• Lifting Frequently (34-66%) 35lbs+ (w/assisted device)
• Carrying Frequently (34-66%) 20lbs - 35lbs
• Pushing Occasionally (3-33%)
• Pulling Occasionally (3-33%)
• Climbing Rarely (Less than 2%)
• Balancing Frequently (34-66%)
• Stooping Occasionally (3-33%)
• Kneeling Occasionally (3-33%)
• Crouching Occasionally (3-33%)
• Crawling Rarely (Less than 2%)
• Reaching Frequently (34-66%)
• Gross Manipulation (Handling) Frequently (34-66%)
• Fine Manipulation (Fingering) Frequently (34-66%)
• Feeling Constantly (67-100%)
• Foot Use Rarely (Less than 2%)
• Vision - Far Constantly (67-100%)
• Vision - Near Constantly (67-100%)
• Talking Constantly (67-100%)
• Hearing Constantly (67-100%)