Clinical Research Site Lead
Behavioral Health Market Context
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Job Description
act. Our team is driven by our core values: People First, Humility, Integrity, One Team, and Results Accountability.
Position Summary
The Clinical Research Site Lead is responsible for managing and executing clinical trials in accordance with study protocols, ICH/GCP guidelines, sponsor requirements, and Rovia SOPs. This role partners closely with site teams to support study startup, enrollment, data quality, and overall study success.
Key Responsibilities
• Conducts and coordinates patient visits in accordance with study protocols.
• Performs clinical tasks such as vital signs, EKGs, specimen collection and processing, and phlebotomy as applicable.
• Ensures informed consent is properly obtained and documented.
• Educates and guides participants through the study, ensuring a positive patient experience.
• Monitors subject safety, reports adverse events, and escalates concerns as appropriate.
• Completes timely and accurate source documentation and EDC data entry.
• Resolves data queries and ensures data integrity.
• Maintains investigational product accountability and proper storage and handling.
• Prepares for and supports monitoring visits, audits, and inspections.
• Collaborates with site staff and investigators to ensure protocol adherence and efficient visit flow.
• Perform other duties as assigned.
Skills/Abilities
• Strong knowledge of medical terminology and clinical procedures.
• Understanding of ICH/GCP and regulatory requirements.
• Excellent organizational skills and attention to detail.
• Strong interpersonal and patient-facing communication skills.
• Ability to multitask and manage competing priorities in a fast-paced environment.
• Proficiency in Microsoft Office, EDC, and CTMS applications.
• Ability to work both independently and collaboratively.
• High level of professionalism and commitment to patient confidentiality.
Education/Experience
• High school diploma required, bachelor’s degree in related field preferred.
• 4+ years of clinical research experience.
• Experience with patient-facing activities (phlebotomy, vital signs, EKGs, etc.) strongly preferred.
The Pay Range For This Role Is
65,000 - 75,000 USD per year(Ridgeland)
Position Summary
The Clinical Research Site Lead is responsible for managing and executing clinical trials in accordance with study protocols, ICH/GCP guidelines, sponsor requirements, and Rovia SOPs. This role partners closely with site teams to support study startup, enrollment, data quality, and overall study success.
Key Responsibilities
• Conducts and coordinates patient visits in accordance with study protocols.
• Performs clinical tasks such as vital signs, EKGs, specimen collection and processing, and phlebotomy as applicable.
• Ensures informed consent is properly obtained and documented.
• Educates and guides participants through the study, ensuring a positive patient experience.
• Monitors subject safety, reports adverse events, and escalates concerns as appropriate.
• Completes timely and accurate source documentation and EDC data entry.
• Resolves data queries and ensures data integrity.
• Maintains investigational product accountability and proper storage and handling.
• Prepares for and supports monitoring visits, audits, and inspections.
• Collaborates with site staff and investigators to ensure protocol adherence and efficient visit flow.
• Perform other duties as assigned.
Skills/Abilities
• Strong knowledge of medical terminology and clinical procedures.
• Understanding of ICH/GCP and regulatory requirements.
• Excellent organizational skills and attention to detail.
• Strong interpersonal and patient-facing communication skills.
• Ability to multitask and manage competing priorities in a fast-paced environment.
• Proficiency in Microsoft Office, EDC, and CTMS applications.
• Ability to work both independently and collaboratively.
• High level of professionalism and commitment to patient confidentiality.
Education/Experience
• High school diploma required, bachelor’s degree in related field preferred.
• 4+ years of clinical research experience.
• Experience with patient-facing activities (phlebotomy, vital signs, EKGs, etc.) strongly preferred.
The Pay Range For This Role Is
65,000 - 75,000 USD per year(Ridgeland)
Qualifications
- •Strong knowledge of medical terminology and clinical procedures
- •Understanding of ICH/GCP and regulatory requirements
- •Excellent organizational skills and attention to detail
- •Strong interpersonal and patient-facing communication skills
- •Ability to multitask and manage competing priorities in a fast-paced environment
- •Proficiency in Microsoft Office, EDC, and CTMS applications
- •Ability to work both independently and collaboratively
- •High level of professionalism and commitment to patient confidentiality
- •4+ years of clinical research experience
Benefits
- •65,000 - 75,000 USD per year(Ridgeland)
Responsibilities
- •The Clinical Research Site Lead is responsible for managing and executing clinical trials in accordance with study protocols, ICH/GCP guidelines, sponsor requirements, and Rovia SOPs
- •This role partners closely with site teams to support study startup, enrollment, data quality, and overall study success
- •Conducts and coordinates patient visits in accordance with study protocols
- •Performs clinical tasks such as vital signs, EKGs, specimen collection and processing, and phlebotomy as applicable
- •Ensures informed consent is properly obtained and documented
- •Educates and guides participants through the study, ensuring a positive patient experience
- •Monitors subject safety, reports adverse events, and escalates concerns as appropriate
- •Completes timely and accurate source documentation and EDC data entry
- •Resolves data queries and ensures data integrity
- •Maintains investigational product accountability and proper storage and handling
- •Prepares for and supports monitoring visits, audits, and inspections
- •Collaborates with site staff and investigators to ensure protocol adherence and efficient visit flow
- •Perform other duties as assigned