Clinical Research Associate II

$93,000 - $100,000/Yr

Cochlear - Oklahoma City, OK

Full-time - Mid Level

Remote - Oklahoma City, OK

Merchant Wholesalers, Durable Goods

About the position

The Clinical Research Associate II at Cochlear plays a vital role in supporting clinical trials by ensuring compliance with regulatory requirements and Good Clinical Practice (GCP). This position involves managing site staff, conducting monitoring visits, and maintaining essential study documentation, all while contributing to the continuous improvement of clinical operations. The role is integral to the success of clinical research efforts at Cochlear, a leader in hearing health care.

Responsibilities

• Train and support site staff on study protocols and Good Clinical Practice (GCP).
• Serve as a liaison between clinical trial sites, project managers, and other stakeholders.
• Ensure compliance with internal operating procedures, Good Documentation Practices (GDP), GCP, and applicable regulations.
• Prepare for and conduct site visits to monitor compliance with study protocols and regulatory requirements.
• Create, review, and maintain essential study documentation and ensure timely documentation of trial-related activities.
• Support operational aspects of clinical trials including device ordering and vendor management.
• Participate in internal and external audits and support continuous process improvement efforts.

Requirements

• Bachelor's degree in a scientific discipline such as biology, chemistry, or a related field.
• 2-4 years of experience in medical device clinical research, with at least 2 years in clinical monitoring.
• Certification from recognized bodies such as ACRP or SOCRA is preferred.
• Familiarity with FDA regulations, GCP guidelines, IDE requirements, and IRB processes.
• Strong knowledge of the clinical research process and medical terminology.
• Proficiency in clinical trial management systems (CTMS) and relevant software such as eTMF and EDC platforms.

Nice-to-haves

• Certification from recognized bodies such as the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SOCRA).

Benefits

• Medical, dental, and vision insurance
• Life and disability insurance
• 401(K) matching with immediate vesting
• Paid Time Off
• Tuition reimbursement
• Maternity and paternity leave
• Employee Stock Purchase Plan
• Pet insurance