Steven Gosein
Senior CRA III, Global Monitoring Operations Oncology embedded with Novartis Pharmaceutical at PRA Health Sciences- Claim this Profile
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English Native or bilingual proficiency
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French Native or bilingual proficiency
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Spanish Limited working proficiency
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Italian Elementary proficiency
Topline Score
Bio
Catherine Derasp
Steven’s enthusiasm, attention to detail and work ethic have allowed him to have exposure to multiple areas within the organization. In my interactions with Steven, he was always open-minded and flexible in an ever changing environment. He was able to coordinate critical activities, provide instruction and oversight - all to ensure the successful and timely completion of projects. I know that Steven will be successful in his future endeavors!
Deirdre Mark, LPN
Steven is a very career driven individual who applies all of his skills to strive and accomplish his goals. With his fast learning and great social skills Steven is very easy to work with, adapt to new concepts and tasks. Pleasure to work with.
Catherine Derasp
Steven’s enthusiasm, attention to detail and work ethic have allowed him to have exposure to multiple areas within the organization. In my interactions with Steven, he was always open-minded and flexible in an ever changing environment. He was able to coordinate critical activities, provide instruction and oversight - all to ensure the successful and timely completion of projects. I know that Steven will be successful in his future endeavors!
Deirdre Mark, LPN
Steven is a very career driven individual who applies all of his skills to strive and accomplish his goals. With his fast learning and great social skills Steven is very easy to work with, adapt to new concepts and tasks. Pleasure to work with.
Catherine Derasp
Steven’s enthusiasm, attention to detail and work ethic have allowed him to have exposure to multiple areas within the organization. In my interactions with Steven, he was always open-minded and flexible in an ever changing environment. He was able to coordinate critical activities, provide instruction and oversight - all to ensure the successful and timely completion of projects. I know that Steven will be successful in his future endeavors!
Deirdre Mark, LPN
Steven is a very career driven individual who applies all of his skills to strive and accomplish his goals. With his fast learning and great social skills Steven is very easy to work with, adapt to new concepts and tasks. Pleasure to work with.
Catherine Derasp
Steven’s enthusiasm, attention to detail and work ethic have allowed him to have exposure to multiple areas within the organization. In my interactions with Steven, he was always open-minded and flexible in an ever changing environment. He was able to coordinate critical activities, provide instruction and oversight - all to ensure the successful and timely completion of projects. I know that Steven will be successful in his future endeavors!
Deirdre Mark, LPN
Steven is a very career driven individual who applies all of his skills to strive and accomplish his goals. With his fast learning and great social skills Steven is very easy to work with, adapt to new concepts and tasks. Pleasure to work with.
Credentials
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Full Accreditation - AAHRPP
Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP)Dec, 2011- Nov, 2024
Experience
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PRA Health Sciences
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United States
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Research Services
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700 & Above Employee
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Senior CRA III, Global Monitoring Operations Oncology embedded with Novartis Pharmaceutical
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Jul 2018 - Present
Hematology/Oncology + CAR-T Hematology/Oncology + CAR-T
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IQVIA
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United States
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Hospitals and Health Care
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700 & Above Employee
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Senior Clinical Research Associate, Site Management Northeast US and Canada Region
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Jan 2016 - Jul 2018
Oncology + Endocrinology + Respiratory Oncology + Endocrinology + Respiratory
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Diex Recherche
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Canada
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Think Tanks
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1 - 100 Employee
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Director of Clinical Operations
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Aug 2013 - Oct 2015
•Directed daily operations of 15 employees over 2 clinics.•Managed 15 direct-report employees as well as several PI’s/Sub-I’s•Coordinated and managed protocol feasibility, regulatory submissions, assisted and completed Site Selection, Study Start-Up, Investigator Meetings, Site Initiation, Routine Monitoring and Close out Visits.•Ensured protocol and sponsor’s objectives were in line with SOPs, ICH guidelines, GLP, & GCP.•Experienced in on-site monitoring, TMF organization and requirements at the Site, CRO and Sponsor levels.•Participated in revision, implementation and administration of ICFs. •Coordinated and supervised subject recruitment activities & created and implemented advertising campaigns. •Implemented appropriate oversight mechanisms to ensure compliance with all regulations.•Managed and participated in auditing and inspection activities.•Executed the overall conduct of clinical operations in order to successfully achieve the contract requirements.•Liaised directly with PIs, sponsors, monitors, vendors and other members of the research team on a weekly basis.•Managed storage/accountability for the receipt, dispensing, administration and destruction of controlled and non-controlled IP to patients, as well as the study inventory and special permits for importation.•Created, reviewed, implemented and executed the use of source documentation as well as managed eCRF timelines and data entry.•Actively implicated in patient visits, consenting, and collecting data throughout enrollment in a confidential manner.•Reported, documented and answered deviations as well as ensured proper reporting and follow-up of AEs & SAEs. •Participated in revision of SOPs and site training procedures.•Systems used: MEDIDATA, BIOCLINICA, INFORM, DATA LABS, RAVE, OCRDC, AXIOM, CRF HEALTH, IVRS •Therapeutic area covered: Cardiovascular, Dermatology, Oncology, Endocrinology, Urology, Immunology, Nephrology, Infectious Diseases, Pulmonary/Respiratory, Vaccines.
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Algorithme Pharma | An Altasciences Company
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Canada
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Supervisor, Clinical Operations
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May 2011 - Aug 2013
• Supervised daily operations of 75+ employees over 4 clinics (230-bed facility).• Responsible for participant safety, successful execution and conduct of all clinical trials.• Determined logistics and identified training needs for the conduct of multiple clinical trials.• Managed 18 direct-report employees (Registered Nurses, Licensed Practical Nurses and Clinical Technicians). • Liaised with Training Department, Study Managers, Monitors and Sponsors to ensure successful execution of trials. • Ensured protocol, sponsor’s objectives, and SOPs, ICH, GLPs, GCPs were respected in daily operations.• Developed, implemented and managed a training plan for the research team in order to reduce errors, and refine skills related to Investigational Product Administration, Blood Sampling, Vital Sign Acquisition, ECG Acquisition, Blood Processing and Centrifugation as well accurate reporting of Adverse Events.• Developed, implemented and managed two Green Belt projects (Lean Six Sigma) to reduce costs associated with the indemnification process of participants + to manage clinical staffing needs.
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MDS Pharma Services
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United States
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Pharmaceutical Manufacturing
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300 - 400 Employee
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Sample Management Manager
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Sep 2009 - Sep 2010
• Created and managed a Sample Management Team of 8 employees.• Coordinated the pre-analysis set-up of biological specimens using Watson for sample receipt/storage/shipment. • Operated the department with respect to protocol, sponsor’s objectives, and all regulations (SOPs, GLPs, GCPs.).• Developed, implemented and managed the departmental decommissioning plan for site closure. • Liaised with clients and coordinated the disposal/return of samples with the Sample Management Team.
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Clinical Conduct Specialist (Assistant Study Manager
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May 2008 - Sep 2010
• Managed and coordinated the initiation and execution of multiple clinical trials.• Liaised with clients and various internal departments to manage financial requirements and milestones.• Created source documents for source data collection. • Trained technical staff in study-specific procedures as well as all general study functions. • Updated the Study Manager on a regular basis regarding technical & staff issues. • Coordinated the schedule of operational staff (Nurses, Lab Techs, etc.) and the set-up and logistics of all laboratory, medical equipment and supplies needed to operate efficiently.• Trained in all technical study functions (Please see Clinical Conduct Technician role for details of study functions). • Requested to travel to MDSs New Jersey site for two months to audit employees, re-train employees and to implement new processes to better manage daily operations.
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Clinical Laboratory Technician + Officer
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Jul 2007 - May 2008
• Supervised clinical research team and designated to oversee participant safety and data collection.• Demonstrated authority, resolved technical issues, and made quick accurate decisions under pressure. • Acted as a communication liaison to Management.• Responsible for performing technical study functions as required by the protocol and in accordance with all SOP, GLP and GCP regulations. • Trained in all technical study functions (vital signs, reporting adverse events, ECG’s, meals, assisting with blood collection, centrifuging/aliquotting blood/serum for sample analysis, dosing medication, urine aliquotting for sample analysis, spirometry testing, cognitive testing).• Maintained certification as a Clinical Training Specialist training new hires.• Monitored clinical study events and addressed Quality Control queries. • Biohazard handling and disposal.
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Clinical Research Study Participant Recruiter
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Jul 2006 - Jul 2007
• Screened and recruited participants by posing a series of questions regarding their medical history. • Booked screening appointments, administered Informed Consent Forms, pre-study questionnaires, verified blood records, post-medical screening follow-up and answered general questions concerning clinical trials.• Completed certification as a Clinical Training Specialist.• Worked with the recruiting manager to ensure 100% bookings for medical screenings.• Developed and implemented marketing strategies for the recruitment process.
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Store Manager
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May 2004 - Mar 2006
• Managed and trained a team of 20+ employees in addition to daily sales targets as well as individual sales goals.• Tracked metrics for optimum performance. • Managed and coordinated projects that would appeal to students, professionals and seniors in obtaining more business for the store.• Coordinated in-store events (Themed events for special weekends: Formula-1, Jazz-Fest, Just for Laughs).• Managed and acquired the accounts of the local businesses in the area. • Managed and trained a team of 20+ employees in addition to daily sales targets as well as individual sales goals.• Tracked metrics for optimum performance. • Managed and coordinated projects that would appeal to students, professionals and seniors in obtaining more business for the store.• Coordinated in-store events (Themed events for special weekends: Formula-1, Jazz-Fest, Just for Laughs).• Managed and acquired the accounts of the local businesses in the area.
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Education
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2003 - 2007
Concordia University
B.A., Urban Planning -
2000 - 2002
CEGEP - John Abbott College
DEC (Partial), Health Science -
1995 - 2000
Lower Canada College
High School Degree
Community
