Clinical Research Associate II

Location: Candidates must be located in New Jersey or Pennsylvania.

About the role

The Clinical Research Associate II (CRA II) participates in the preparation and execution of pre-market to post-market clinical trials. Oversees the progress of clinical investigations by conducting site qualification, initiation, interim, and close-out visits to clinical sites. Monitors clinical trials in accordance with Good Clinical Practices and procedures set forth by RQM+ and sponsors. Works closely with the Clinical Trial Manager (CTM) and/or Lead CRA to ensure all monitoring activities are conducted according to study requirements.

Responsibilities

• Collaborates with the start-up department to coordinate activities with assigned sites in preparation for the initiation of the study.
• Obtains regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials.
• Works with start-up, project team, and site staff to obtain regulatory (IRB/IEC) approval of study-specific documents.
• Performs study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF, monitoring activities, and study close-out activities.
• Trains site staff on the EDC system.
• Assists in resolving any issues to ensure compliance with site file audits in conjunction with eTMF.
• Assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits.
• Performs validation of source documentation as required by sponsor and prepares monitoring reports and letters per the timelines defined in RQM+ SOPs by using approved templates and reports.
• Documents accountability, stability, and storage conditions of investigational and commercial product inventory as required by sponsor.
• Ensures return of unused study product to designated location or verifies destruction as required.
• Reviews the quality and integrity of the clinical data through in-house review of electronic CRF data and on-site or remote source verification.
• Works with sites to resolve data queries.
• Serves as primary contact between RQM+, sponsor, and investigator; coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested.
• Performs study close-out visits per the study-specific Clinical Monitoring Plan including final study product reconciliation and disposition, site study file reconciliation, data query resolution through to database lock, and resolution of outstanding action items.
• Assists with, and attends, Investigator Meetings for assigned studies.
• Authorized to request site audits due to data integrity concerns.
• Attends study-related, company, departmental, and external meetings, as required.
• Ensures internal and study-related trainings are completed per RQM+ process and/or study timelines, including updating the study-level trial management system.
• Ensures all study deliverables are completed per RQM+ and study timelines.
• Serves as mentor for junior staff and those new to the company and/or study.
• Participates in training and mentoring new staff up to Clinical Research Associate level as appropriate.
• Performs other duties, as requested.

Requirements

• Bachelor's Degree in scientific discipline or health care preferred.
• At least 2 years of on-site monitoring experience.
• In-house or remote monitoring experience preferred.
• Equivalent combination of education, training, and experience considered.
• In-depth knowledge of, and skill in applying, applicable clinical research regulatory requirements, i.e., Clinical Trial Regulation, Good Clinical Practice (ICH-GCP) guidelines, and international standards like ISO 14155.
• MedTech regulations and active experience preferred.
• Strong therapeutic and protocol knowledge as provided in company training.
• Proficiency in the use of Microsoft Word, Excel, and PowerPoint, and use of a laptop computer and mobile technology.
• Written and verbal communication skills including command of English language.
• Organizational and pragmatic problem-solving skills.
• Effective time and financial management skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, sponsor staff, and sites.
• Ability to act in a lead role on a study assuming additional responsibilities as detailed/documented by the Project Manager if appropriate.
• Ability to travel up to 60-75%.

Behaviors

• Action-Oriented
• Approachability
• Building Effective Teams
• Business Acumen
• Career Ambition
• Composure
• Courage (Managerial)
• Customer Focus
• Decision Quality
• Informing
• Integrity & Trust
• Interpersonal Savvy
• Planning

Pay

$90,000–$97,000

Work Environment & Physical Requirements

This role involves regular travel to client and partner sites, which may include varying office and facility environments. The employee should be able to travel independently, navigate different facility types, and occasionally lift or carry items up to 20 lbs. (e.g., equipment, materials, luggage).

Benefits

RQM+ considers employees our biggest asset and invests heavily in ongoing learning and development. Benefits include an industry-leading compensation package and a focus on work-life balance. Employees are regarded as members of the RQM+ family.