Associate, Pharmacokinetics will apply his expertise in pharmacology and pharmacokinetics and knowledge of regulatory requirements to design Phase I/II clinical studies, provide scientific support during studies conduct, evaluate the study results and take part in preparation of clinical study reports. Associate, Pharmacokinetics will also provide scientific support for study teams in the areas of pharmacology, pharmacokinetics and regulatory guidelines for clinical trials conduct and will be an important contributor to the enhancement of scientific foundation of the company.

• Performs literature and data evaluation to provide scientific background for clinical studies design
• Prepares the PK portion of synopses for clinical studies
• Answers inquiries in process of preparation and reviews study protocols
• Performs/reviews pharmacokinetic analysis of concentration-time data
• Prepares/reviews the pharmacokinetic section of study reports
• Interacts and provides input and feedback to Biostatistics Department for data analysis
• Reviews statistical output to evaluate study results
• Reviews study reports
• Provides scientific support to other departments and teams in the areas of pharmacology, pharmaceutics and pharmacokinetics
• Takes part in revision of the Biopharmaceutics Department and the company SOPs; provides input into departmental practices and maintains updated the study- and report-related templates
• Maintains the Biopharmaceutics Department databases; provides the department and the company with updated scientific literature and maintains regulatory guidelines updated

• M.Sc. in Pharmacy/Pharmacology or related field or B.Sc. Pharmacy/Pharmacology plus minimum 2 year experience with clinical trials design/data analysis
• Expertise in the fields of pharmacology and pharmacokinetics
• Proven abilities in literature evaluation, scientific and medical writing and scientific support
• Demonstrated analytical thinking with strong attention to detail
• Good organizational skills and ability for multitasking and prioritization

Send your resume via E-mail: jhe@biopharmaservices.ca or

Fax: 416-747-8480

• To perform any technical and administrative functions as education & training allows; including any medication administration as required by the protocol and in accordance with implemented procedures, SOP’s, GLP, GCP regulations and the all-regulatory bodies.
• To conduct the Inform Consent process and ongoing communication of study information to subjects.
• To ensure subjects are efficiently monitored and that safety requirements or actions are implemented as necessary.
• To report every adverse event, irregularity or non-compliance that occurs during the study.
• To ensure that all documentation is accurate.
• To ensure liaisons with physicians as necessary.
• To assist on training as assigned. To perform any other study related tasks as required or any additional duties as professional qualifications and training allows

• Education: RN with current registration with regulatory body in Ontario.
• Current BCLS &First Aid certification, ACLS & GCP an asset.
• Acute care experiences an asset.
• 2-3 years experience in CRO environment (preferably in conduct of Phase I/Bioequivalence studies)
• Skills: Good interpersonal skills, good communication skills. Attentive to details, good initiative and able to work with changing priorities. Computer skills an asset.
• Ability to accommodate a flexible work schedule
• Evening/Weekend availability required

Send your resume via E-mail: kdesouza@biopharmaservices.ca or

Fax: 416-747-8480

• Conduct of procedures according to Protocol, applicable Good Clinical Practice (GCP) guidelines, applicable regulations and BioPharma Services Inc. Standard Operating Procedures (SOPs) at all times.
• Obtaining Blood/Urine samples, obtaining ECGs, performing a subject demographics verification, processing Blood/Urine samples for shipment to the appropriate clinical diagnostic laboratory, obtaining subject’s Height, Weight and Frame size. Setting up the clinic according to the study requirements.
• Provide support as required, including but not limited to labeling of the specimen containers, copying, numbering, binding and archiving of project and supporting documentation
• Conducting pre-shipment sample inventories and preparing sample shipments
• Other duties as may be required & as training and experience allow

• 2 year Medical Technology Diploma, or equivalent
• 1-2 years work experience in a CRO (preferably in conducting Phase I /Bioequivalence clinical trials)
• 1-2 years of recent phlebotomy and ECG experience
• A minimum of 1 year of experience in a basic laboratory setting
• Flexible hours depending on business requirements.
• Rotating shifts and weekend requirements.

The Biostatistician will be responsible for all matters relating to planning, preparation, review and interpretation of data for clinical studies for regulatory submissions, and providing both leadership skills as well as technical expertise to the project teams. The incumbent will participate in developing clinical trial protocols, write Statistical Analysis Plans, perform statistical analyses, and generate Statistical and Clinical Study Reports.

• Develop SAS codes to create accurate, complete and efficient statistical analysis datasets; and to generate statistical analysis output tables, listings and graphs.
• Strong ability to develop SAS® programs; knowledge of applications and interpretation of SAS® procedures.
• Solid understanding of clinical drug development process and knowledge of FDA regulatory requirements and ICH/GCP guidelines is preferred.
• In-depth knowledge of regulatory requirements in clinical studies
• Conduct all work in compliance with Standard Operating Procedures (SOP’s) and to observe all FDA guidelines.

• A university degree BSc, M.Sc or Ph.D. in Statistics with SAS programming experience is required.
• At least 2 years of clinical experience in biostatistics or 5 years of experience in the pharmaceutical industry.
• Experience in CRO environment preferably in conduct of Phase I and Bioequivalence studies
• Good interpersonal skills, good communication skills.
• Attentive to details, good initiative and able to work with changing priorities.

Reports to: Manager, Project Management

• Manage Phase I/BE program and all other activities associated with our services
• Maintain a tracking process for the studies managed; including initiation, tracking, timelines reporting, budgeting and report writing
• Maintain awareness of overall study requirements in accordance with finalized protocol and ensure this is adhered to in all projects managed under your responsibility
• Within scope of position, provide sound scientific advice to clients either directly or via other BPSI staff; co-ordinate teleconferences with appropriate personnel, address client questions, concerns or comments
• Negotiate client’s milestones and assist staff as required
• Use appropriate communication tools to update clients on the status of their project(s); should there be any deviation, immediately handle them appropriately and if required notify Director, Project Management and/or Operations
• Actively participate in the weekly tracking meeting making sure you are current with the most current information from operations and provide any new client information
• Create and develop quotations for review by DPM and receive appropriate signatures as required
• Follow up with existing accounts on new business opportunities and manage activities around outstanding quotations, Confidentiality Agreements, Contracts etc.
• Whenever appropriate, maintain awareness and provide input on study designs and protocols
• Assist in the preparation and maintenance of all departmental reports and all tracking databases; ensure that they are updated accurately and issued in a timeline fashion (includes quotation and contract templates, weekly tracking reports, financial reports etc.)
• Ensure appropriate documents have been reviewed and circulated within BPSI prior to providing to clients
• If required, assist in promotion of BPSI at industry meetings and trade shows
• Maintain a good understanding of regulatory guidelines (TPD, FDA, EMEA, ICH, TGA, ANVISA) and understanding of basic pharmacokinetics and statistics
• Assist finance department in developing transfer of pertinent financial information

• Bachelor of Science (B.Sc.) degree or equivalent
• Relevant background in the healthcare, pharmaceutical industry
• Minimum of 2 years experience in a project management role in either Phase I/BE or Phase I - IV setting
• Familiarity with the management of all phase I/BE
• Demonstrated experience dealing with a wide variety of project stakeholders at all levels in and across various organizational departments
• Excellent interpersonal, communication and presentation skills
• Strong organization, prioritization and problem solving skills
• Ability to manage and handle several projects simultaneously
• Highly proficient in MS Office Suite (Word, Excel, PowerPoint, MS Project)

This position will be responsible for analyst the clinical data of clinical studies following the protocol and the statistical analysis plan, and generate Statistical and Clinical Study Reports.

• Develop and validate SAS codes to analysis clinical study data, generate output tables, listings and graphs in according to the study protocol and the statistical analysis plan
• Develop and validate SAS codes to perform data management tasks such as logic checks, data query, data cleaning, data listing and data export
• Perform statistical analysis on clinical study data, drug safety data, and write statistical reports
• Assist in creating and CRF and data management plans (DMP)
• Create randomization scheme for clinical studies
• Write and update SOPs
• Perform other miscellaneous activities as required

• A university degree BSc, M.Sc in Statistics with SAS programming experience is required.
• Solid understanding of clinical drug development process and knowledge of FDA and other regulatory requirements and ICH/GCP guidelines.
• In-depth knowledge of regulatory requirements in clinical studies
• At least 2 years of SAS programming experience in the pharmaceutical industry.
• Experience in CRO environment preferably in conduct of Phase I and Bioequivalence studies
• Good interpersonal skills, good communication skills.
• Attentive to details, good initiative and able to work with changing priorities.
• Possesses an excellent understanding of the clinical data management process

Send your resume via E-mail: jhe@biopharmaservices.ca or

Fax: 416-747-8480

This position leads the clinical data management process for the clinical trials and supervises the data entry team.

• Supervise and train the data entry team
• Develop study specific database for mainly Phase I studies and potentially for Phase II‑IV clinical studies
• Design and review CRF according to the study protocol
• Write and review Data Management Plans and other key study documents
• Create, review, and process Data Clarification Forms and updates the databases
• Lead the clinical data management process for clinical studies
• Develop Data Management SOPs and  training other staffs
• Perform other miscellaneous activities as required

Qualification & Experience:

• B.A./B.S. Degree in a related field or an appropriate combination of relevant education and experience.
• A minimum of 3 years clinical data management related experience
• Experience in developing CRF and setting up database
• Awareness of applicable regulatory rules and guidelines: e.g. ICH, GCP, GDP etc.
• Possesses excellent interpersonal and communication skills (written and verbal).
• Good project management and organizational skills
• Proficient in relevant computer software
• Possesses an excellent understanding of the clinical data management process

Send your resume via E-mail: jhe@biopharmaservices.ca or

Fax: 416-747-8480

Reports to: Director, Biopharmaceutics

Manages and coordinate data management and statistics analysis activities and resources for clinical research, in accordance with ICH guidelines, applicable regulatory requirements, Good Clinical Practices (GCPs) and standard operating procedures (SOPs).

• Over look the data management and statistical analysis aspects within BPSI for clinical studies
• Manage and coordinate the activities of the biostatistics team and data management team to meet corporate goals and objectives
• Develop project and department standards to ensure consistency
• Collaborate with management across functional areas to set priorities and timelines
• Provide expert critical review of clinical trial protocols to ensure alignment with project objectives
• Monitor data quality during study conduct for BA/BE and Phase I-IIa studies
• Provide advice on study design including identification of clinical endpoints and sample size estimation
• Provide expertise on regulatory guidance and requirements for the collection, analysis, and presentation of clinical data
• Provide expert critical review to clinical study reports, integrated summary documents and publications
• Represent BioPharma Services before regulatory bodies and the sponsors
• Responsible for the data quality and the accuracy of the statistical result
• Develop statistics analysis and data management strategy for clinical studies
• Contribute expert statistical input on regulatory questions
• Perform statistical analysis, determine the precise conclusions, write statistical reports and/or prepare data presentations for clinical registration
• Ensure data management plan (DMP) statistical analysis plans (SAPs) are in line with project objectives and consistent with project standards
• Participate in planning resource and budget needs
• Write/review SOPs relative to Biostatistics and Data Management

Qualification & Experience:

• M.Sc. in biostatistics and 5+ years clinical research experience in pharmamaceutical industry or CRO
• 3+ years of lead biostatistics experience
• 3+ years data management experience
• In-depth knowledge of pharmaceutical clinical development and ability to apply technical principles, theories and concepts to clinical drug development
• Understand regulatory drug submissions and approval process at the regional level
• Understanding of data management, statistics, pharmacokinetics,  protocol development, and report writing concepts and techniques of clinical trial principles
• Thorough knowledge of SAS procedures and clinical data processing with emphasis on regulatory agency requirements for data reporting
• Extensive knowledge of FDA/ICH regulations/guidelines
• Previous interaction with regulatory agencies on data management, statistics, and medical writing issues
• Excellent written and verbal communication skills and interpersonal skills

Send your resume via E-mail: jhe@biopharmaservices.ca or

Fax: 416-747-8480

Reports to: Chief Operating Officer

Position Summary :

The purpose of this role is to support the conduct of BPSI’s multi-site Phase I/IIa clinical trials, BE studies in patients, and clinical endpoint trials, to support all aspects of these clinical trials including design, planning, and implementation.

One of the primary responsibilities of this position is to identify, recruit and initiate Investigators/Investigators sites capable of meeting study enrolment targets for various patient populations

This position interacts with the Chief Operating Officer, Associate Director, Clinical Operations, Clinical Operations team, Business Development and Project Management team, internal staff in all other departments throughout BPSI, Sponsors, Clients, Investigators and their study teams,  and Vendors.

• Assist Management in assessing project feasibility by researching availability/ accessibility of the target patient population.
• Identify, recruit and initiate Investigators/Investigators sites capable of meeting study enrolment targets for various patient populations.
• Coordinate and participate in clinical research studies conducted by principal investigator.
• Maintain primary responsibility of a variety of regulatory tasks including: assess, complete, and submit protocol related documents to the appropriate regulatory review committees and maintain essential staff documents.
• Support the smooth operation of domestic and international clinical trials by monitoring case report forms for completeness, legibility and conformity to applicable regulations and SOPs.
• Monitor site compliance with clinical protocol and reporting deviations and violations
• Develop study documents, including and not limited to, clinical protocols, informed consent forms, and case report forms.
• Interpret clinical data and evaluate deviations.
• Track the progress of study enrollment and treatments.
• Ensure the accuracy and completeness of site regulatory documentation including drug accountability records; ethic committee approvals and reports, and adverse event documentation.
• Conduct investigator meeting, site qualification, site initiation, monitoring and close out visits, as required.
• Assist with clinical protocols, CRFs, and site training materials.
• Assist with IRB/EC submissions/reports.
• Assist in management of Medical Monitor and DSMB.
• Work with investigator sites and CRO’s regarding contracts, invoicing, scope of work and project timelines.
• Assist in management of clinical databases and data entry.
• Manage clinical study documentation.
• Ensure compliance with appropriate BPSI SOP’s, GCP and ICH guidelines.
• Build and expand company’s network of physician researchers.
• Responsible for remaining current with regulatory requirements (TPD, FDA, EMEA etc.) and organizing presentations for clinical staff on applicable changes in regulations.
• Provide monthly progress updates to the management team.
• Perform any other duties as required, as training and experience allow.

Working Conditions and Environment:

• Travel 25-50% time, including within Toronto and possibly international, as required.

Qualifications:

• Nursing Degree
• Current RN license (Ontario) mandatory, ACLS trained preferred.
• CRA experience in pharmaceutical industry, including 3-5 years with Phase I-III clinical trials.
• National certification preferred as CRA (e.g., Association of Clinical Research Professionals (ACRP), Society of Clinical Research Associates (SOCRA))
• Experience in recruiting new investigators and patients for clinical trial enrollment within Toronto and internationally.
• Working knowledge of GCP regulations.
• Experience with databases (Excel/Access) and spreadsheets.
• Strong organizational, interpersonal and communication skills are required to interact effectively with patients and their families, Physician Researches and other healthcare providers.
• Someone with established investigator contacts in Toronto preferred, in the areas of arthritis, psoriasis, Alzheimer’s or diabetes.
• Detail-oriented, and able to follow multiple, detailed directions of various research protocols.
• Proven ability to develop and build and maintain effective relationships.
• Self starter, energetic with initiative, professionalism.
• Solid organizational skills with the capacity to prioritize and multi-task.
• Strong team and customer service orientation with ability to work in a fast paced, growing environment.
• Ability to maintain information in confidence and exercise good judgment.
• Demonstrated technical competence with MS Word, PowerPoint, Excel, and Internet, Outlook, and Salesforce.com or similar CRM database.

Send your resume via E-mail: lyeghikyan@biopharmaservices.ca or

Fax: 416-747-8480

Reports to: Manager, Clinical Operations

To monitor subject safety while they are in confinement, in compliance with the study protocols, SOP’s regulatory requirements and fulfill business needs of the company.

• To perform any technical and administrative functions as education & training allows; including any medication administration under physician’s directions as required by the protocol and in accordance with implemented procedures, SOP’s, GCP regulations and regulatory bodies
• To conduct the Inform Consent process and ongoing communication of study information to subjects.
• To ensure subjects are efficiently monitored and that safety requirements or actions are implemented as necessary.
• To report adverse events, irregularity or non-compliance that occurs during the study.
• To ensure that all documentation is accurate.
• To liaise with the Principal Investigator and/or physician as necessary.
• To assist on training as assigned.
• To perform any other study related tasks as required or any additional duties as professional qualifications and training allows.

Qualification & Experience:

• Education: Foreign doctor
• Current BCLS & First Aid certification.
• Skills: Good interpersonal skills, good communication skills. Attentive to details, good initiative and able to work with changing priorities. Computer skills an asset.
• Ability to accommodate a flexible work schedule

Send your resume via E-mail: kdesouza@biopharmaservices.ca or

Fax: 416-747-8480

Reports to: Supervisor, Clinical Research

Position Summary:

The clinical Research Coordinator (CRC) is responsible for coordination and management of Phase I and Bioequivalence studies in accordance with the Protocol, BioPharma Services Inc. Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) guidelines, and applicable regulations.  The CRC is responsible for providing guidance to clinic staff, overseeing all aspects of assigned studies and ensuring that all relevant time lines are met.

• Responsible for monitoring of study activities.
• Coordinate all study activities to ensure protocol and regulatory requirement(s) are met (e.g. sample collection, sample processing, clinic set-up, etc.).
• Protocol Training for clinical research staff.
• Perform ECG, Vital signs, Collect Routine Safety Labs.
• Obtain Informed Consent as appropriate.
• Compliance check on subjects.
• Adverse Event Reporting and Serious Adverse Event reporting to appropriate departments(s).
• Proper Collection, handling and processing of PK samples.
• Supervise, administer and /or assist in drug administration.
• Maintain study files for each clinical trial and completion of Case Report Forms.
• Write and/or review source documents forms.
• Appropriate control, inventory, storage, and record keeping of study drug(s).
• Assist in dispensing study drug(s).
• Write and Revise SOPs, internal procedures and ensure the accuracy of generated data in accordance with protocols, ICH, GCP and applicable regulatory agencies.
• Maintain adequate, accurate, complete and legible records.
• Provide study updates and statistic reports to management (e.g. study update, month end report).
• Responsible for remaining current with regulatory requirements (TPD, FDA, EMEA etc.).
• To perform any other duties required, as training and experience allow.

Qualifications:

• Postsecondary degree in a science or healthcare related discipline, or equivalent work experience.
• 1-2 years of relevant clinical research experience (preferably in conducting Phase I/ Bioequivalent studies).
• Ability to accommodate a flexible work schedule and to adapt to changing priorities; able to work under pressure.
• Excellent problem solving, communication, multitasking and interpersonal skills.
• Certification in Clinical Research an asset.
• Computer Literacy.

Send your resume via E-mail: lco@biopharmaservices.ca or jvilafana@biopharmaservices.ca

Fax: 416-747-8483

• Enter and/or update potential volunteer information in the Recruitment Database
• Offer study participation and provide tentative study information to potential study volunteers
• Administer telephone questionnaires to potential study volunteers
• Book, reschedule and/or cancel medical screening appointment(s) for potential study volunteer(s).
• Perform screening reception duties as required, including but not limited to ID verification, recording of Demographic information (Medical Screening staff only). 
• Build and maintain solid relationship with study volunteers by providing excellent customer service
• Resolve any volunteer related issues in a professional and timely manner
• Provide metrics on advertisement, performance and recruitment activities
• Provide statistical reports to management e.g. month end report, study recruiting stats
• Participate in departmental meetings and assist management in implementing outlined departmental initiatives and developing strategies to maintain and increase subject retention
• Perform any other duties as required permissible by training and experiience

• A minimum Grade 12 high school diploma
• 1-2 years experience in a customer service environment
• Strong organizational, time management and planning skills to work independently with efficiency and accuracy
• Excellent interpersonal and public relation/customer service skills
• Strong team player with ability to multi-task in a fast-pace environment
• Experience in dealing with and handling confidential information
• Proficiency in English, with excellent oral and written communication skills
• Proficiency in Microsoft Word and Microsoft Excel

Reports to: Supervisor, Medical Screening

Performs all designated/ assigned medical screening tasks in compliance with study protocol, SOPs, GCP and regulatory requirements.

• Obtains written informed consent from potential subjects.
• Interviews and records potential subject’s medication/smoking/substance use/medical/surgical history and demographic information.
• Obtains Vital Signs, performs electrocardiogram (ECG), obtains body measurements and calculates Body Mass Index (BMI).
• Collects/processes blood and urine samples, conducts screening for drugs of abuse and cotinine, perform breath alcohol test and any other medical screening related activities as required.
• Accurate and timely completion of all applicable medical screening records in compliance with the study protocol, SOPs,  GCP/GDP and regulatory requirements.
• Perform data review of the medical screening source and/or other related documents as required.
• Provide excellent customer service to current and potential study participants.
• Resolve possible subject issues/concerns, performs data entry/transcription (e.g. CRF completion) when required.
  
• Performs any other study related tasks or any additional duties as professional qualifications and training allows.

• Education: Non-Ontario Medical Doctor with a diploma from an institution recognized by WHO (i. e. foreign-trained physician)
• Current BCLS & First Aid certification
  
• 2-3 years experience in CRO environment (preferably in CRO conducting Phase I / Bioequivalence studies)
• Proficiency in English language and Medical Terminology; excellent oral and written communications skills
• Strong organizational, time management and planning skills. Ability to work independently with high efficiently and accuracy in a high-pressure environment.
• Attention to details, excellent documentation practices.
• Ability to deal with and resolve difficult situations. Computer skills are an asset (e.g. MS Word, Excel, etc.).
• Able to accommodate flexible hours depending on business requirements (e.g. rotating shifts, evenings and weekends)