Description

Reports to: VP, Clinical Operations

SPI is seeking a proactive and experienced CRA to join our growing clinical operations team. As a CRA, you will be responsible for monitoring clinical trials from initiation to close-out, ensuring they are conducted according to the study protocol,  ICH-GCP guidelines, and local regulatory requirements. 

This is a dynamic, hybrid (remote and field-based) role that involves travel to investigative sites, monitoring, collaboration with cross-functional teams, and regular interaction with clinical site staff. 

Key Responsibilities: 

Site Management

•       Prepare and conduct site visits (remote / onsite): site qualification, initiation, monitoring, and closeout.
•       Oversee site performance, subject recruitment, and compliance with study protocol.
•       Train and support site staff on protocol and compliance with ICH-GCP, SOPs, sponsor requirements, and local regulatory guidelines.

Data & Documentation Compliance

•       Perform source data verification (SDV), ensure accurate data entry in Electronic Data Capture (EDC) systems, resolve data discrepancies, and meet database milestones.
•       Identify and report protocol deviations, safety issues, or non-compliance, and assist in implementing Corrective and Preventive Actions (CAPA).
•       Maintain and review Investigator Site Files (ISF) and Trial Master File (TMF) for completeness and compliance. 
•       Write monitoring reports and follow-up letters. 

Investigational Product (IP) Accountability

•       Verify proper storage, handling, and documentation of the IP at the sites
•       Verity subject’s drug compliance per protocol

Liaison & Communication

•       Serve as the primary point of contact for investigative sites.
•       Collaborate with cross-functional teams (regulatory, data management, safety) and site personnel to ensure study timelines and quality metrics are met. 
•       Represent the organization in a professional capacity.

Requirements

Qualifications:  

Education

•       Bachelor’s degree or advanced degree in life sciences or health-related field is required
•       Clinical background and/or successful completion of an industry recognized CRA training program is a plus.

Experience

•       2 – 5+ years of clinical monitoring experience in a CRA role (CRO or sponsor setting).
•       Solid understanding of ICH-GCP, regulation guidelines, clinical trial phases (I – IV), and monitoring processes.
•       Experience with EDC systems (e.g., ClinCapture, Medrio), CTMS, and eTMF.
•       Therapeutic area experience (e.g., Otolaryngology, Neurotology)
•       Proficient in SharePoint, MS Outlook, Word, PowerPoint and Excel products.

Certifications (Preferred)

•       GCP certification (Mandatory)
•       CRA certification (ACRP or SOCRA)

Other Requirements

•       Willingness to travel ground and air (40 – 60% depending on the study)
•       Excellent written and verbal communication skills, documentation, time management, organizational, and problem-solving skills. 
•       Ability to work both independently and in a matrixed team environment.
•       Perform co-monitoring and serve as backup CRA as requested.
•       Ability to manage multiple priorities under minimal supervision, including writing reports during travel time or in remote locations such as hotels or airports.
•       Diligence and dedication to quality in all work tasks and deliverables. 
•       Provide support and contribute to departmental training and process improvement initiatives.
•       Willingness to learn new internal processes and filing systems for visibility and efficiency. 

SPI offers competitive salaries and an excellent benefits package. Successful incumbent will be able to grow professionally and play a key role in improving patient outcomes and medical innovation. Sound Pharmaceuticals, Inc is an Equal Opportunity Employer.