Lead a multi-disciplinary team in the conduct of a cost-effective, ethical and results focused, publishable study that supports the defined business objectives.
Oversee Site Qualification, Site Initiation, Interim and Close-out Monitoring Visits to ensure Investigator Compliance.
Liaise with Clinical Research Associate (CRA) to create and implement required study documentation and plans including the study protocol in line with local Institutional Review Board (IRB) or Ethics Committee (EC) requirements, local regulatory guidelines and SOPs to ensure that all studies are conducted in a compliant manner.
Manage site and subject enrollment, receipt of clinical data and reporting of adverse events to established timelines.
Act as primary contact between clinic trial sites and sponsor for all study specific needs including routine investigator updates.
Create and distribute study related metrics to internal and external stakeholders including weekly and monthly updates within team, cross functional teams or senior management, and externally for clinical study sites.
Anticipate potential obstacles to clinical study success, prepare and communicate contingency plans and implement process improvements.

Requirements

Bachelor’s degree and 3 to 5 years of medical device or pharmaceutical clinical research experience or an advanced degree in hearing science, audiology or related field and 1 to 2 years of medical device or pharmaceutical clinical research experience.
Clinical Research certifications from ACRP or SOCRA preferred.
Intermediate knowledge of Good Clinical Practice (GCP), International Conference of Harmonisation (ICH), Code of Federal Regulations (CFR) and ISO14155 (CITI Certification preferred).
Experience with electronic data capture (EDC) and electronic trial master file (eTMF) systems, project planning and managing budgets.
Travel is required at 30%.

Benefits

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical researchsite qualificationsite initiationmonitoring visitsstudy protocoldata reportingcontingency planningprocess improvements

Soft Skills

leadershipcommunicationorganizationalproblem-solving

Certifications

ACRP certificationSOCRA certificationCITI certification