Senior Clinical Research Associate

Company : CYNET SYSTEMS

Job Overview:

Pay Range: $87hr – $92hr

• Support end to end clinical research activities to ensure successful study start up and execution through regulatory approval.
• Manage and track clinical study data, site performance, and study progress.
• Assist in investigator selection, training, and patient recruitment activities.
• Support site start up and activation including preparation of study documentation and monitoring plans.
• Work with clinical systems including EDC, CTMS, eTMF, and imaging platforms.
• Review regulatory submissions, consent forms, and documentation to ensure compliance.
• Assist in updating clinical study documents including protocols, CRFs, and monitoring plans.
• Conduct site visits including qualification, initiation, monitoring, and close out activities.
• Perform source data verification to ensure accuracy and compliance.
• Support clinical trial sites with data entry, query resolution, and study oversight.
• Collaborate with data management teams to support data cleaning and validation.
• Maintain clinical documentation and reporting including study files and status reports.
• Assist in audit preparation and support during internal and external audits.
• Support investigator meetings, site training, and study presentations.

Requirements/Must Have:

• Strong experience in clinical research and clinical trial management.
• Knowledge of Good Clinical Practice and regulatory requirements.
• Experience with clinical trial systems such as EDC, CTMS, and eTMF.
• Experience in protocol development, informed consent, and regulatory documentation.
• Ability to manage multiple priorities and work in cross functional teams.
• Strong communication and stakeholder management skills.
• Ability to travel as required.

Experience:

• Minimum 8 plus years of clinical research experience with a bachelor s degree or equivalent.
• Minimum 6 plus years of experience with advanced degree in nursing or related field.
• Minimum 5 plus years of experience with advanced degrees such as master s, MD, or PhD.

Responsibilities:

• Coordinate and manage clinical trial activities across sites.
• Ensure compliance with protocols and regulatory requirements.
• Conduct monitoring visits and validate study data.
• Support study planning, execution, and reporting.
• Assist in audit preparation and regulatory inspections.
• Collaborate with stakeholders to ensure successful study delivery.

Skills:

• Clinical research and trial management.
• Regulatory compliance and GCP knowledge.
• Data management and validation.
• Communication and stakeholder coordination.
• Problem solving and organizational skills.

Qualification And Education:

• Bachelor s degree in a related field required.
• Advanced degree such as Nursing, Master s, MD, or PhD is preferred.
• Certification in clinical research or trial management is preferred.
• Knowledge of statistics and clinical study design is preferred.

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