Janna Cleem Email & Phone Number

Kansas City, Kansas, United States

Fargo, North Dakota, United States

- Review batch records for Cell Banks and Pre-Banks manufactured for Biotech company that produces gene therapy-Assist with the creation of MSR (Manufacturing Summary Reports) that are provided to the client upon release of product.-Track all documents that are reviewed within QA department via Smartsheet program- Maintaining quality assurance standards, processes, and controls while developing and implements methods for inspection, testing, sampling, and training- Support quality assurance programs, processes, and facilities by ensuring compliance with regulatory, internal and client requirements in the manufacture of products- Assist with implementation and training of all employees regarding the quality system and overall compliance with the corporate quality manual- Identify compliance through auditing process-Support of the CAPA system by ensuring all events are adequately investigated, appropriate CAPA actions are put into place and records are closed within a timely manner- Support of Aldevron's internal audit program to ensure processes are performed in accordance with written procedures and other applicable external requirements - Support validation process by reviewing protocols, testing plans and final reports, as assigned

Fargo, North Dakota Area

• Helped open research site.• Managed and trained new staff in Recruiting, Screening, Reception, and Screening QC. • Reviewed study protocols and consent forms prior to IRB (Institutional Review Board) submission to catch errors.• Reviewed Screening Source Documents for errors prior to beginning the screening process.• Screened volunteers for research studies (reviewed Informed Consent Forms with volunteer, collected a medical history, collected a height and a weight, administered ECG, phlebotomy and urine sample collection, vital signs, processed blood and urine samples collected form screening visit.• Performed phlebotomy during clinical research trails and worked as a Clinical Technician: Centrifuged blood samples, pipette plasma from blood samples into aliquots, and froze samples to be shipped out for analysis.• Trained in Screening QC: Reviewed screening source documents filled out during the screening process for errors and had staff correct error and properly document why correction was being made.• Processed/shipped screening labs for specialty studies for analysis determined by study sponsor.• Met with sponsors wanting to place studies within company and discussed our processes and their goals for study placement.• Created documents for staff to recruit volunteers for research studies.• Entered study related criteria into recruiting program called PRM to begin the recruiting process.• Published studies to the company website that we were actively recruiting volunteer for.• Entered information into (VCT) Verified Clinical Trials prior to the screening process beginning.• Maintained and scheduled staff for department needs.• Monitored staff productivity.• Interviewed candidates for department and dealt with disciplinary issues within the department.• Administered annual reviews.• Conducted meetings within the department as needed.• Recruited volunteers for research studies over the phone and in person.

Dilworth, Mn

• Helped open research site. • Wrote SOP's (Standard Operating Procedures). • Created training documents for new staff. • Ordered supplies.• Set up study units.• Managed and trained Recruiting and Screening staff. • Trained on EDC (Electronic Data Capture) program. • Reviewed protocols and created documents for staff to recruit and screen volunteers for research studies. • Recruited volunteers for research studies. • Screened volunteers for research studies (reviewed Informed Consent Forms with volunteer, collected a medical history, collected a height and a weight, administered ECG, phlebotomy and urine samples, collected vital signs.• Performed phlebotomy and monitored subjects during clinical research studies.

Fargo, North Dakota Area

• Helped open research site. • Managed and trained staff. • Reviewed protocols for research studies. • Created documents to aid staff in volunteer recruiting efforts. • Recruited volunteers for research studies.

Fargo, North Dakota Area

• Answered service calls from technologists and connected them to engineers to repair MRI machines. • Documented calls between technologists and engineers in Microsoft Great Plains software. • Opened up service tickets with vendors as required.• Scheduled service repairs as needed.

• Reviewed study protocols and designs for research projects.• Created documents to aid recruiting associates in finding study participants for research projects.• Tracked staff productivity for advancement.• Monitored status of active studies recruiting to ensure successful completion of the project.• Reviewed documentation from pharmaceutical sponsors about project changes and make appropriate changes to materials used to recruit subjects.• Attended meetings with upper management to implemented policies.• Trained staff in Recruiting and Screening department.• Filled in for Screening Manager as needed.• Screened participants for upcoming projects.• Met with staff about productivity and gave direction as needed.• Handled disciplinary issues when needed.• Maintained training documents.• Managed projects within in-house computer system.• Organized, prioritized, and delegated tasks to staff.• Organized study subjects for research projects• Reviewed call center reports (Cisco) weekly or as needed and made appropriate staffing changes.• Listened to staff phone calls with subjects for quality and gave direction as needed.

Fargo, North Dakota Area

• Reviewed study consent forms with interested participants explaining the details of the study.• Determined subject’s eligibility through reviewing participant’s medical history.• Collected blood pressure readings.• Performed electrocardiograms.• Collected blood and urine samples from subjects.• Reviewed study documents and collected appropriate signatures.• Followed proper OSHA cleaning regulations and restocked the phlebotomy lab.• Assisted as needed in clinical studies performing phlebotomy during studies.

Fargo, North Dakota Area

• Identified subjects for upcoming research projects testing name brand vs. generic medication in clinical research trials• Made outbound and took inbound calls from subjects interested in participating in research projects (60-80 calls per day).• Informed subjects about requirements for participation in study projects, reviewed study dates, and determined eligibility.• Scheduled screening appointments for subjects wanting to participant in research study.• Contacted participants with project changes.• Contacted participants with other potential study projects when the participant was better suited for a different project.

Fargo, North Dakota Area

• Provided customer service for clients in the photography industry.• Placed photofinishing orders for clients.• Sold photography equipment and accessories.• Prepared profession portrait orders for clients.• Scheduled studio appointments.• Assisted customers with self-serve photo processing machines.• Answered phone.• Rang up orders.• Reconciled till at end of day.• Worked at all 4 locations.

Ceramic Arts

High School Diploma