Population:

Study Details:

Study Dates:

Session 2

Confinement:  Check-in on Wednesday, Jun 05, 2013 @ 5pm

Exit on Friday, Jun 07, 2013 @ 9am

Session 3

Confinement: Check-in on Wednesday, Jun 12, 2013 @ 5pm

Exit on Friday, Jun 14, 2013 @ 9am

Additional Info:

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.

Duties and Responsibilities:

• 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 s 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.

Please send your resume to lco@biopharmaservices.ca OR lson@biopharmaservices.ca

Position Reports to: Supervisor, Clinical Operations

Duties and Responsibilities:

• Review study protocol and participate in the protocol training meeting prior to performing any study related activities.
• Maintain accurate, complete, legible and timely data entry
• Collect/process blood and urine samples as well as other specimens as required.
• Catheter insertion and removal
• Proper collecting, handling and processing of PK samples
• Process and ship lab samples
• Perform ECG and Vital Signs
• Compliance check on subjects
• Perform drug/cotinine screen and alcohol test as well as urine pregnancy test.
• Obtain body measurements including height and body weight, and calculate Body Mass Index (BMI).
• Assist in drug administration by performing hand and mouth check
• Serve and/or monitor meals
• Perform data review of the source and/or other related documents as required.
• Other duties as required

Qualifications:

• Medical Technology  Diploma, or equivalent
• Excellent verbal, written communication skills
• Strong interpersonal skills are required
• Ability to work flexible hours depending on business requirements; including evenings and weekends
• OSMT and CPR certification
• 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
• Ability to interact with all departments on a professional level.

In August 2012 and March 2009, Bio Pharma Services Inc. also successfully completed two US FDA audits without any findings.

“At BioPharma Services, we strive to exceed Good Clinical Practices and set the bar high on quality, science and operational execution when conducting bioanalytical lab testing and clinical work at our GCP-compliant facilities. We are proud that esteemed governmental institutions like the UK MHRA and Health Canada recognize our commitment to excellent quality assurance and compliance in bioanalytical testing and early stage clinical research,” cited Mr. Renzo DiCarlo, CEO of BioPharma Services Inc.

About BioPharma Services Inc. BioPharma Services Inc. is a physician-owned, physician-run, FDA-inspected, UK MHRA-inspected, and Health Canada-inspected Canadian Contract Research Organization (CRO) which specializes in the conduct of Phase I/IIa clinical trials and bioanalysis for innovative pharmaceutical, biotech and medical device companies from US, Canada, Australia and Europe. The company currently has a modern 174-bed clinical facility and a co-located bioanalytical laboratory in Toronto, Canada. The company is privately held, and it is headquartered in Toronto, Canada.

For more information
regarding this release, please contact Ms. Lorelei Lutter at llutter@biopharmaservices.ca.

·         To oversee all associated activities related to a Phase I/BE study program from inception to completion

·         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

·         Develop study budgets and receive appropriate approvals

·         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 timely  fashion

·         If required, assist in promotion of BPSI at industry meetings and trade shows

·         Maintain a good understanding of regulatory guidelines (TPD, FDA, EMEA, MHRA, ICH, TGA, ANVISA) and understanding of basic pharmacokinetics and statistics

·         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, including budget preparation and management

·         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)

Population:

Study Details:

Study Dates:

Exit on Friday, May 31, 2013 @ 8am

Session 2

Confinement: Check-in on Wednesday, Jun 05, 2013 @ 5pm

Exit on Friday, Jun 07, 2013 @ 8am

Session 3

Confinement: Check-in on Wednesday, Jun 12, 2013 @ 5pm

Exit on Friday, Jun 14, 2013 @ 8am

Additional Info:

Population:

Study Details:

Study Dates:

Confinement:

Check-in on Saturday, May 25, 2013 @ 5pm

Exit on Monday, May 27, 2013 @ 8am

Return    :

Monday, May 27, 2013 @ 7pm

Tuesday, May 28, 2013 @ 7am

Wednesday, May 29, 2013 @ 7am

Session 2

Confinement:

Check-in on Saturday, Jun 01, 2013 @ 5pm

Exit on Monday, Jun 03, 2013 @ 8am

Return    :

Monday, Jun 03, 2013 @ 7pm

Tuesday, Jun 04, 2013 @ 7am

Wednesday, Jun 05, 2013 @ 7am

Session 3

Confinement:

Check-in on Saturday, Jun 08, 2013 @ 5pm

Exit on Monday, Jun 10, 2013 @ 8am

Return    :

Monday, Jun 10, 2013 @ 7pm

Tuesday, Jun 11, 2013 @ 7am

Wednesday, Jun 12, 2013 @ 7am

Additional Info:

Build and maintain solid relationship with study   volunteers by providing excellent customer service

Meet with potential Japanese speaking volunteers off site at multiple locations to discuss and provide materials regarding participating in studies and enrollment in the Recruitment database.

Engage with Japanese speaking volunteers online using social media, email and chat communications channels.

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 experience Qualifications & Experience: Time management and planning skills   to work independently with efficiency and accuracyExcellent interpersonal and public relation/customer   service skillsStrong team player with ability to multi-task in a  fast-pace environmentExperience in dealing with and handling confidential  information

Proficiency in Japanese, with excellent oral and written   communication skills, and the ability to communicate effectively in English using both oral and written communication skills

Proficiency in Microsoft Word and Microsoft Excel is an advantage. Send   your resume via E-mail:   bbooth@biopharmaservices.ca or Fax: 416-747-8482 ]]> http://www.biopharmaservices.ca/?feed=rss2&p=705 0 http://www.biopharmaservices.ca/?p=692 http://www.biopharmaservices.ca/?p=692#comments Fri, 15 Feb 2013 01:19:28 +0000 admin http://www.biopharmaservices.ca/?p=692

Population:

Study Details:

Study Dates:

Check-in on Wednesday, May 22, 2013 @ 5pm

Exit on Friday, May 24, 2013 @ 8am

Return   :

Friday, May 24, 2013 @ 7pm

Session 2

Confinement:

Check-in on Wednesday, May 29, 2013 @ 5pm

Exit on Friday, May 31, 2013 @ 8am

Return:

Friday, May 31, 2013 @ 7pm

Session 3

Confinement:

Check-in on Wednesday, Jun 05, 2013 @ 5pm

Exit on Friday, Jun 07, 2013 @ 8am

Return:

Friday, Jun 07, 2013 @ 7pm

Additional Info: