Senior Associate, Clinical Research

Paycom - ATS; Irvine (CA); On-site; USD 95,000 - 105,000; Full time

Job summary

Paycom - ATS in Irvine, CA is seeking a Senior Clinical Research Associate to support pre-market clinical studies and ensure regulatory compliance under the Director, Clinical Affairs.

The ideal candidate will have thorough knowledge of Good Clinical Practice (GCP) and applicable regulations and will assist with data management, site coordination, and audits. This is a full-time, on-site position offering a competitive salary.

Qualifications

• 2+ years of experience in clinical trial research (medical devices preferred).
• Advanced degree in biological sciences/ pharmacy/ nursing desirable.
• Excellent written and verbal English communication skills.
• Deep knowledge of GCPs and applicable regulations.

Responsibilities

• Support site management and interact with site coordinators, investigators, and field monitors to meet protocol requirements in a timely manner.
• Ensure quality data management activities – data review, query generation and resolution; generate status reports to clinical staff and management.
• Generate queries to resolve data issues and apply corrections to the database.
• Act as a point person for all data related to the clinical group and provide data to cross-functional departments.
• Conduct EDC training to external teams and sites.
• Maintain Trial Master Files and trackers for clinical trials.
• Manage trial-related regulatory documents and provide follow-up action listings to ensure regulatory compliance with IRB/EC policies.
• Conduct periodic audits of internal files to ensure compliance per site IRB/EC policies.
• Provide clinical operational support during preparation for and conduct of audits and inspections.
• Contribute to development and implementation of departmental policies, standards, and process improvements.
• Partner with management to manage external vendors and supplier qualification.
• Assist field monitors in site training and monitoring visits.
• Support co-monitoring of local sites as needed.

Skills

Clinical trial management

EDC systems

English communication

GCP knowledge

Attention to detail

Team collaboration

Education

4 Year Degree

Advanced degree in biological sciences/pharmacy/nursing

Tools

EDC platforms

Job description

Job Details: Job Location: Irvine, CA 92618, Position Type: Full Time, Education Level: 4 Year Degree, Salary Range: $95,000.00 - $105,000.00 Salary/year, Job Title: Senior Associate, Clinical Research

Role Level: Individual Contributor (IC)

Supervisor/Manager Title: Director, Clinical Affairs

Job Location & Environment: Irvine, CA, Corporate Office

Job Description Summary

The Senior Clinical Research Associate will report to the Director, Clinical Affairs, and will play a key role in proactively supporting the conduct of pre-market clinical studies and ensure compliance with all regulatory requirements. The ideal candidate will have a thorough knowledge of Good Clinical Practices (GCP) and applicable regulations.

Job Responsibilities

• Support site management and interact with site coordinators, investigators, and field monitors in collecting data and resolving queries to meet the protocol requirements in a timely manner.
• Ensure quality data management activities – i.e., data review, query generation and resolution. Generate status reports to clinical staff and management.
• Generate queries to resolve data issues and apply corrections to database.
• Act as a point person for all data related to clinical group, and to provide data to cross-functional departments.
• Conduct EDC training to external teams and sites.
• Maintain Trial Master Files and trackers for clinical trials.
• Manage trial-related regulatory documents and provide follow-up action listings to ensure that all clinical documentation required by regulations and JenaValve procedures is current.
• Conduct periodic audits of internal files to ensure compliance per site Institutional Review Board (IRB) and/or Ethics Committee (EC) policy (i.e. IRB continuing review approval period and expiration dates).
• Provide clinical operational support during preparation for and conduct of all clinical audits and inspections.
• Contribute to the development and implementation of departmental policies, standards, and process improvement initiatives.
• Partner with management to manage external vendors, including ongoing supplier qualification.
• Assist field clinical monitors in preparation for site training and monitoring visits
• Support co-monitoring of local sites on an as-needed basis.

Qualifications: Required Education and Experience

• 2+ year of experience in clinical trial research is required (preferred in medical devices).
• Advanced degree in a biological science / pharmacy/ nursing desired.

Skills and Abilities Required for This Job

• Proficient in clinical trial management and electronic data capture systems to document and record information.
• Excellent communication skills (written and verbal English) so as to be able to build effective relationships with trial center staff and colleagues.
• Deep knowledge of GCPs governing the conduct of clinical trials; working knowledge of Medical Device Directive 93/42/EEC, ISO14155 and ICH guidelines.
• Very organized and able to pay close attention to detail.
• Team player with a willingness to help where needed and work with diverse people.

Physical Requirements

• Ability to travel up to 20% time.