Jeff Witkowski Email & Phone Number

Lyons, Co

• Utilze Knowledge of applicable SOPs, guidelines and study procedures•Assist with protocol and CRF review•Assist with the development of study manuals, annotated CRFs, monitoring conventions, tracking forms, site study tools, and other study materials•Conduct study feasibility and site selection activities •Develop and implement innovative approaches for and participates in site recruitment, selection and initiation activities•Assist with investigator meeting activities including organization, preparation and attendance •Conduct site management activities including but not limited to site selection visits, site initiation visits, site training, site routine monitoring visits, and site close out visits•Ensure the integrity of clinical data and adherence to applicable regulatory, protocol, and company guidelines•Write study visit reports and follow up letters within the timeline established by applicable SOPs and guidelines •Coordinate timely shipment of clinical supplies and study drug to sites •Ensure proper storage, dispensation and accountability of clinical supplies and study drug•Maintain adequate site tracking records •Follow up of drug safety issues and safety reports in timely manner •Develop and implementation of corrective action •Assist with data query form (incl. query process) •Perform telephone monitoring activities in order to obtain study status information•Prepare /review all patients tracking records •Input and maintain study information concerning subject status of financial reimbursement to sites. •Conduct and assist with administrative activities as a member of the project team. •Conduct on the job training and formal training to other CRAs and Clinical Trials Assistants•Collaborate with Regional Monitoring Manager or Clinical Operations Manager/study teams to resolve site issues•Participate in routine study progress meetings, face to face or via teleconference

Lyons, Co

• Utilze Knowledge of applicable SOPs, guidelines and study procedures•Assist with protocol and CRF review•Assist with the development of study manuals, annotated CRFs, monitoring conventions, tracking forms, site study tools, and other study materials•Conduct study feasibility and site selection activities •Develop and implement innovative approaches for and participates in site recruitment, selection and initiation activities•Assist with investigator meeting activities including organization, preparation and attendance •Conduct site management activities including but not limited to site selection visits, site initiation visits, site training, site routine monitoring visits, and site close out visits•Ensure the integrity of clinical data and adherence to applicable regulatory, protocol, and company guidelines•Write study visit reports and follow up letters within the timeline established by applicable SOPs and guidelines •Coordinate timely shipment of clinical supplies and study drug to sites •Ensure proper storage, dispensation and accountability of clinical supplies and study drug•Maintain adequate site tracking records •Follow up of drug safety issues and safety reports in timely manner •Develop and implementation of corrective action •Assist with data query form (incl. query process) •Perform telephone monitoring activities in order to obtain study status information•Prepare /review all patients tracking records •Input and maintain study information concerning subject status of financial reimbursement to sites. •Conduct and assist with administrative activities as a member of the project team. •Conduct on the job training and formal training to other CRAs and Clinical Trials Assistants•Collaborate with Regional Monitoring Manager or Clinical Operations Manager/study teams to resolve site issues•Participate in routine study progress meetings, face to face or via teleconference

- Merck and Pfizer Alliances- Implement and monitor phase I-V clinical trials to ensure sponsor and investigator obligations are being met and sites are compliant with applicable local regulatory requirements, ICH guidelines, project SOPs and sponsor requirements- Perform source document verification utilizing sponsor Electronic Data Capture systems, conduct drug accountability and ensure patient safety at investigative sites- Conduct site visits to assess the qualifications of potential investigative sites, initiate studies, train site personnel on the proper conduct of studies, review data and ensure data collection accuracy, and close out studies- Serve as primary point of contact for sites, working closely with sites to achieve data entry, query resolution, and specific training according to sponsor timelines- Review, approve and submit regulatory documents to trial master file for all protocols- Ensure Serious Adverse Event (SAE) reporting is completed according to project specifications- Provide regular clinical status information to team members and project management- Address requests and issues from investigative sites in timely fashion- Track and plan trial dates, as well as train sites in sponsor systems; achieved First Site Ready for numerous trials while establishing new Investigator sites- Create and submit visit reports using sponsor specific systems- Track and approve site payments- Establish recruitment plan and strategy for sites, assist in tracking recruitment and implementing appropriate actions- Specific monitoring experience in Oncology (Breast, Lung, Prostate, Hematologic, Pediatric, Vaccine, Bladder, Kidney, Skin)

- Galderma certified as an expert to conduct/train meeting participants in protocol-related efficacy assessments.- Assisted with online tools for training, instructed foreign trainees in preparation for certification.

Longmont, Colorado

- Coordinated all aspects of Phase II, III & IV clinical trials including patient screening and recruitment, patient enrollment, conducting patient visits, completing and ensuring the quality of case report forms, in-house monitoring and maintaining regulatory documents.- Worked on over 45 trials in various therapeutic areas: Endocrinology, Cardiology, Oncology, Dermatology, Pediatrics, Respiratory

Longmont, Co

- Directed wellness programs for all Maxtor sites in the United States. - Developed and presented behavior change programs and health management seminars company-wide. - Performed employee health screenings and developed individualized follow-up programs. - Managed daily operations at Maxtor Fitness Center, including supervision of fitness staff, creating budget and hiring staff.

Sterling Heights, Mi

- Coordinated employee wellness programs. - Performed fitness assessments, exercise prescription, personal training and supervision of co-workers. - Directed the exercise programming of the wellness center focusing on weight loss and strength training.

Atlanta, Ga

- Conducted exercise stress tests under direct and indirect medical supervision, performed bone density scans for osteoporosis, drew blood for necessary testing, and ordered medical supplies. - Designed diet and exercise programs based on fitness evaluations and one-on-one counseling. - Coordinated several Phase III and IV pharmaceutical studies, including designing and conducting a sub-study protocol for growth hormone treatment.

Atlanta, Ga

- Presented information on exercise and diabetes to patients and families of The Diabetes School. - Developed new section in exercise chapter of patient information booklet Intensive Diabetes Management Program.

Bachelor Of Science, Physical Education And Exercise Science

Master Of Science, Exercise Science