Clinical Trial Specialist

Position Summary

A Clinical Trial Specialist provides operational and regulatory support for the Caris sponsored studies and collaborative Pharma studies ensuring activities are conducted per standard operating procedures and best practice principals. Responsibilities will include, but not limited to, study documentation maintenance, IRB submissions, leading site onboarding activities, driving site engagement through routine status meetings/ touch points, study enrollment/ accrual reporting, specimen tracking, accessioning, and inventory.

Job Responsibilities

• Successfully execute site onboarding process in an effective and timely manner
• Develop and maintain a thorough understanding of study content, workflows, and procedures to successfully conduct the Site Initiation Visit meeting and offer ongoing site support.
• Monitor and facilitate local site IRB and central IRB activities, including additional site submissions, amendments/changes in research submissions, create/facilitate submission of annual continuing review reports, monitor and notify of document expiration dates, and process fees through accounts payable.
• Oversees creation of new study and site Trial Master File (TMF) entries, including site information and required documents.
• Ensures proper regulatory, legal, and financial disclosure documentation are on file in accordance with standard operating procedures, data management plan and/or study protocol.
• Maintains operational study documents; SOPs, Working Instructions, Lab Manuals, User Guides, and study specific forms that include tracking, preventative maintenance, instrument logs, quality assessments, reports and audits.
• Communicates cross functionally (internally and externally) on all research study operational changes; ensuring questions and issues are answered/addressed or provided to the appropriate group.
• Responsible for ensuring sample integrity and maintaining Good Clinical Practice (GCP) compliance for samples through chain of custody, sample handling guidelines, and proper storage conditions. This includes, but not limited to, collecting requisite information, performing data entry for sample tracking/reporting, sample inventory, sample distribution and communicating status with key stakeholders (internal/external).
• Oversees the shipment tracking, receipt, storage/inventory, maintenance and transfer/distribution of non-clinical samples and clinical study biospecimens.
• Maintains workflows in accordance with approved Standard Operating Procedures (SOPs). Assists in process improvement within the department under direction of manager.
• Reviews specimen requests for proper approvals, maintains documentation of chain of custody, and routes for fulfillment.
• Enters specimen information into Sample Management System.
• Reviews associated specimen submission documentation and verified accuracy of data entry.
• Coordinates and assists in deidentification of specimen requests for purposes of research.
  
  

Required Qualifications

• Associate or higher degree with biological science coursework required.
• Proficient in Microsoft Office Suite, specifically Word, Excel, PowerPoint, and Outlook.
• Candidates should have 1-2 years’ experience in a Biorepository setting or Clinical Trial setting.
• Experience in handling human biological materials
• Demonstrates the ability to effectively and respectfully communicate with coworkers, staff, sponsors, and clients.
• Continuously provides excellent customer service in an efficient and effective manner.
• Excellent organization and time management/prioritization skills with the ability to both independently and with specific direction on a diverse and demanding workload
• Attention to detail and problem-solving skills.
• Ability to multi-task and work in a fast-paced, deadline driven environment.
• Results oriented, hyper focused on service, quality, and continuous improvement.
  
  

Preferred Qualifications

• Candidates should have previous experience in a Biorepository setting or Clinical Trial setting.
• Candidates should have experience with clinical trial regulatory documentation or TMF.
• Candidates should have a strong understanding of laboratory settings and processes and must be able to adapt to varied levels of workload in a dynamic environment.
• Laboratory Information Management System or Sample Management System experience preferred.
• Customer service experience is preferred.
• Good Clinical Practice training, IATA training, and Human Subject Protection training preferred.
  
  

Physical Demands

• Ability to stand for more than 1 hour at a time, sit for more than 1 hour at a time.
• Ability to lift up to 30 lbs.
  
  

Training

• Employee will be required to complete Good Clinical Practices, Human Subject Protection, HIPAA, and IATA training.
• All job specific, safety, and compliance training are assigned based on the job functions associated with this employee.
  
  

Other

• This position requires some evenings, weekends and/or holidays.
  
  

Conditions of Employment: Individual must successfully complete pre-employment process, which includes criminal background check, drug screening, credit check ( applicable for certain positions) and reference verification.

This job description reflects management’s assignment of essential functions. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

Caris Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, gender, gender identity, sexual orientation, age, status as a protected veteran, among other things, or status as a qualified individual with disability.