Mica Susla

• Participate in executive oversight activities as assigned
• Represent the CTL function in business development activities
• Serve as the leader of the CTL function for a geographic region
• May be responsible for managing other CTL's, recruiting, training, and other management duties as assigned
• Participate in business development activities as assigned
• Provide education and mentoring to other CTL's
• Serve as the team lead for studies employing multiple CTL's
• Serve as therapeutic expert for internal PRA staff
• Provide detailed reports of interactions with investigators and site staff
• Identify effective prescreening strategies for each trial and recommend improvements
• Be able to communicate the scientific basis of the trials to other team members, investigators and site staff
• Create education Materials to effectively communicate the science behind the clinical trial
• Understands the scientific basis of assigned clinical trials

• Working as eTMF Process Leader Mentoring newly hired Senior CRA on Sponsor processes
• Completes monitoring activity documents as required by sponsor SOPs or other contractual obligations
• Reviews and verifies accuracy of clinical trial data collected, either onsite or remotely
• Escalates site and trial related issues per sponsor SOPs until identified issues are resolved or closed
• Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH GCP guidelines
• Verifies Serious Adverse Event (SAE) reporting according to the trial specifications and ICH GCP guidelines
• Communicates with investigative sites
• Facilitates audits and audit resolution
• Updates applicable tracking systems
• Ensures all required training is completed and documented
• Performs source document verification and query resolution
• Perform essential documentation site file reconciliation
• Works closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues
• Provides regular site status information to team members, trial management, and updates trial management tools
• Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of clinical trials and close clinical trials at investigative sites

Accomplishments:

• Assisted sponsor CLM with preparation of the sides for the bi-weekly Country report to Global Teams
• Effectively worked with site staff on all assigned studies to date, meeting sponsor timelines for startup, activation and data analysis review
• Expert working knowledge of sponsor systems; including but not limited to, RAVE, IRIS, IMPACT and eTMF
• Assisted Feasibility Specialist with work on three planned studie

• Mentored junior CRA's and provided observation visit opportunities for less experienced CRAs
• Assisted project manager with responses to sponsor in preparation for an EU Audit that could have potentially involved United States sites
• Participated in the mock EU audit
• Ensured investigator obligations were met and were compliant with ICH GCP and local regulatory requirements
• Ensured all required training was completed and documented
• Verified SAE reporting according to trial specifications and ICH GCP management
• Performed IP accountability, dispensation and compliance
• Performed investigator site file review for essential documents
• Performed source documentation verification and query resolution
• Assessed the qualification of potential investigative sites, initiated clinical trails at investigator sites, instructed site personnel on the proper conduct of clinical trials and closes clinical trials at investigator sites
• Responsible for clinical trial data review and accuracy verification from source documentation
• Responsible for site management of 6 studies at 26 sites
• Facilitated audits and audit resolution

• Performed site selection visits, site initiation visits, instructed site personnel on the proper conduct of the clinical protocol
• Ensured investigator obligations were met and were compliant with applicable regulatory requirements and ICH GCP guidelines
• Verified SAE reporting according to clinical trial requirements and ICH GCP guidelines
• Performed IP accountability, dispensation and compliance at investigator sites
• Responsible for site management
• Ensured all required training was completed and documented
• Performed essential document site file reconcilation
• Performed source document verification and query resolution
• Reviewed accuracy and verified accuracy of clinical trial data collected onsite

• Responsible for coordinating NCI sponsored trial, and industry Sponsored trials carried out through

• Developed Policy for Pediatric Sickle Cell/Pediatric Special Hematology laboratory for participation in the Performance Improvement Plan at LSUHSC Shreveport
• Developed Cord Blood Screening Program at LSUHSC Shreveport with the Genetic Disease Program
• Services Office of, LA
• Performed Acid and alkaline Hemoglobin electrophoresis, Qnatitiative Hb
• A2 Assays, Quantitative
• Mica Susla
• Clinical Trial Liason
• Curriculum Vitae Aug-2023 Mica Susla 30-Jan-2023 Michelle Setar 30-Jan-2023Generated on: Accuracy of CV confirmed by on: Manager approval by on: ofPage 3 6
• Hb
• F analysis, Quantitative G-6PD assays, Solubility Tests Osmotic Fragility assays and Keihauer
• Betke Stains
• Responsible for the continuing communications between the Shreveport Affiliate Clinic and St
• Jude
• Research Domestic Affiliate Program
• Performed phlebotomy on Pediatric Sickle Cell patients regularly in the Pediatric Sickle Cell Clinic
• Responsible for submission and follow-up of Research protocols from St
• Jude Research Hospital to the Local IRB at LSUHSC-Shreveport
• Assisted the Pediatric Hematologist/Oncologists with Bone Marrow Procedures
• Responsible for collecting and sending inpatient and outpatient data on shared patient to HIMS
• Department, St
• Jude Children's

• Performed Hematology procedures and equipment operation, troubleshooting and quality control

• Performed lab assays in all Laboratory Departments during the 3-11 shift