Experience

Spaulding Clinical Research, LLC

• United States
• Research Services
• 100 - 200 Employee

• Chief Executive Officer

  • Jan 2020 - Present

• Chief Operating Officer

  • Jan 2015 - Jan 2020

  •The Chief Operating Officer is responsible for overseeing all operations daily and reports directly to the CEO. The Chief Operating Officer sees to it that the business operations are smooth and efficient daily, and the business is able to create profit by executing the company’s services efficiently. The Chief Operating Officer works with direct reports, to execute upon goals and strategies that align with the company’s mission and vision. The Chief Operating Officer works closely and… Show more •The Chief Operating Officer is responsible for overseeing all operations daily and reports directly to the CEO. The Chief Operating Officer sees to it that the business operations are smooth and efficient daily, and the business is able to create profit by executing the company’s services efficiently. The Chief Operating Officer works with direct reports, to execute upon goals and strategies that align with the company’s mission and vision. The Chief Operating Officer works closely and collaboratively with the CEO, CFO, and CSO to ensure a cohesive executive team by strategizing, planning, and executing agreed upon initiatives.

• Director of Clinical Operations

  • May 2011 - Dec 2014

  • Managed clinical operations related to Early Phase (Clinical Operations, Pharmacy, Laboratory, Nursing, Recruitment/Enrollment) as well as Biostatistics and Data Management, including hiring, training, scheduling the studies for the respective units, coaching/counseling, evaluating performance and terminating staff as appropriate. • Reviewed and gave feedback on clinical study budgets and contracts with the sales and contracts team for the phase 1 unit services as well as Biometrics… Show more • Managed clinical operations related to Early Phase (Clinical Operations, Pharmacy, Laboratory, Nursing, Recruitment/Enrollment) as well as Biostatistics and Data Management, including hiring, training, scheduling the studies for the respective units, coaching/counseling, evaluating performance and terminating staff as appropriate. • Reviewed and gave feedback on clinical study budgets and contracts with the sales and contracts team for the phase 1 unit services as well as Biometrics services. • Grew Clinical Operations from the capacity of staffing and executing average daily occupancy rates of 15 beds to 130 beds in 4 years while maintaining excellent customer satisfaction. • Developed strategic plan to reduce Cost of Goods of Biostatistics and Data Management services, executed the plan and realized an improvement of 25% study profit margin. • Fully internalized the Biostatistics and Data Management team from a fully contracted/outsourced operation to an internally employed operation. • Met with Managers/Directors regularly to discuss staffing for upcoming studies, sharing of staff/resources between departments, and approval of overtime reports. • Generated overall study timelines and clinical unit’s bed calendar • Supported all FDA and Sponsor Audit/Site visits and inspections for the Phase 1 unit. • Created departmental Standard Operating Procedures (SOPs) and Work Instructions. Approved the review, revision, and/or retirement of SOPs. Upon approval and finalization, managed the training and implementation of departmental SOPs and WIs. • Established a structured training program for per diem staff, and departmental staff, including restructuring of training requirements to ensure accurate levels of training for varying levels of protocol involvement.

• Nurse Practitioner

  • May 2009 - Nov 2014

  • Perform full physical exams and medical evaluations on healthy volunteers to determine eligibility for participation in a research study. • Assisted in review of 12 lead ECGs, clinical laboratory panels including CBC, Chemistries, U/As, serology, and drug testing. •Assisted Principle Investigator in determining the eligibility of healthy volunteers to participate in clinical trials.

• Clinical Research Coordinator

  • Nov 2007 - Dec 2011

  • Coordinated, executed, and assured quality of study protocols in Phase 1 units for large complex TQT studies, BA/BE, SAD/MAD, FIH and DDI studies. • Maintained excellent customer service by working diligently to problem solve and meet customer needs. • Executed various pharmacodynamics measures such as MIP/MEP testing & Dynamometry to detect neuromuscular blockade, Symbol Digits Modalities Test to detect cognitive impairment, Otoacoustic Emissions Audiology testing to detect hearing… Show more • Coordinated, executed, and assured quality of study protocols in Phase 1 units for large complex TQT studies, BA/BE, SAD/MAD, FIH and DDI studies. • Maintained excellent customer service by working diligently to problem solve and meet customer needs. • Executed various pharmacodynamics measures such as MIP/MEP testing & Dynamometry to detect neuromuscular blockade, Symbol Digits Modalities Test to detect cognitive impairment, Otoacoustic Emissions Audiology testing to detect hearing impairment, incentive spirometry, blood glucose testing, women’s health exams, eye exams and color tests, and pharmacogenetic testing. • Responsible for all protocol procedures including patient recruitment and enrollment (assisting Principal Investigators in determining patients had met inclusion/exclusion criteria); CRF design; completing case report forms (CRFs); conducting medical histories; taking vital signs; conduction of ECGs; collection of laboratory tests; and administration of oral, IV, and dermal patch/dermal application study medication to qualified subjects.



LongTermGevity Inc.

• Canada
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Director of Clinical Affairs

  • Nov 2021 - Present