Senior Clinical Research Associate, Sponsor-dedicated (Contract)

About the role

Premier Research is seeking a Senior Clinical Research Associate, Sponsor-dedicated (Contract) to support biotech, medtech, and specialty pharma companies in transforming life-changing ideas into new medicines, devices, and diagnostics. The role involves helping to deliver medical innovation that patients desperately need.

Responsibilities

• Conducts source verification by comparing data on Case Report Forms against source documents, ensuring Informed Consent Forms are accurate and complete.
• Investigates and resolves data discrepancies identified during source verification activities.
• Maintains thorough documentation and properly escalates issues related to visit reports.
• Safeguards compliance by addressing identified non-compliance issues.
• Identifies and reports any reportable events according to protocols and regulations.
• Manages study contracts, requests, and collects relevant investigator/site documentation such as regulatory documents, financial disclosure forms, and CVs/medical licenses.
• Reviews and approves documents in applicable databases.
• Performs budget negotiations with clinical trial sites.

Requirements

• Experience in Neurology or Psychiatry, including work with Schedule I controlled substances, is required.
• Bachelor's degree, or international equivalent, from an accredited institution, preferably in a clinical, biological, scientific, or health-related field, or equivalent combination of education, training, and experience.
• 5 to 7 years of practical experience conducting continuous independent onsite monitoring of clinical research sites as well as site management activities. Alternately, proven experience in all primary job functions.
• Strong analytical and organizational skills, capable of managing multiple projects simultaneously in a fast-paced environment with changing priorities.
• Knowledge of International Conference on Harmonization (ICH)/Good Clinical Practices (GCP) and/or ISO14155 requirements, as well as detailed knowledge of relevant country-specific regulatory requirements for conducting clinical trials.
• Willingness to travel up to 70-85%.

Qualifications

• Experience in Neurology or Psychiatry, including work with Schedule I controlled substances, is required.
• Bachelor's degree, or international equivalent, from an accredited institution, preferably in a clinical, biological, scientific, or health-related field, or equivalent combination of education, training, and experience.
• 5 to 7 years of practical experience conducting continuous independent onsite monitoring of clinical research sites as well as site management activities. Alternately, proven experience in all primary job functions.
• Strong analytical and organizational skills, capable of managing multiple projects simultaneously in a fast-paced environment with changing priorities.
• Knowledge of International Conference on Harmonization (ICH)/Good Clinical Practices (GCP) and/or ISO14155 requirements, as well as detailed knowledge of relevant country-specific regulatory requirements for conducting clinical trials.
• Willingness to travel up to 70-85%.

Skills

• Experience in Neurology or Psychiatry, including work with Schedule I controlled substances.
• Strong analytical and organizational skills.
• Knowledge of ICH/GCP and/or ISO14155 requirements.
• Ability to manage multiple projects in a fast-paced environment.
• Willingness to travel up to 70-85%.

Benefits

This is a 1099 12-month contract position with the potential to extend and renew after 1 year. Premier Research is committed to providing a supportive and inclusive workplace where all employees are treated fairly and with respect.

Pay

The salary range for this position is [Insert Salary Range Here]. Please note that this is a 1099 contract position.

Schedule

The schedule for this role is flexible and may involve some travel, up to 70-85%.