Description

Seeking candidates for upcoming and future openings.

JOB SUMMARY

Coordinates or co-leads assigned clinical research projects in accordance with Protocols, Standard Operating Procedures (SOPs), and applicable regulations.

JOB RESPONSIBILITIES

1. Clinical Research Project Plan and Preparation
   
   
   
   
   1. Review of assigned protocols and other protocol documentation (ICF, IB) for accuracy, feasibility, timing, and resources.
   2. Prepares and maintains the Trial Master File (TMF) for the study.
   3. Participates in creation and review of timelines and start-up meetings (Investigator Meeting/SIV, Sponsor discussions, or other related meetings)
   4. Takes the lead and/or overall coordination of all required start-up activities including, but not limited, to the following:
      
   6. Clinic logistics planning, schedule of clinic activities, and team training
   7. Preparation, review, and/or finalization of clinic source documents, time and events tables, and other required study materials; review of Case Report Forms (CRFs), laboratory workbooks, staff requirements, and schedules
   8. In collaboration with the responsible teams, establishes and/or maintains safety assessment requirements, Quality Control (QC) and monitoring plans, pharmacy/dispensing requirements, study supplies/equipment, meal plans, and other elements as applicable to the study.
   9. Confirms all required regulatory and contractual documentation is present prior to study start.
   
   
2. Clinical Conduct
   
   
   
   1. Coordinates and monitors screening activities; provides support as required.
   2. Coordinates and ensures set-up of clinic rooms, subject chart review, and source preparation prior to start of clinic activities.
   3. Takes the lead and/or overall coordination of clinic activities including, but not limited to:
      
   5. Supervises clinic visits (admission, dosing and randomization, discharge, and follow-up) as required and provides on-call support when applicable.
   6. Ensures volunteer eligibility prior to randomization; oversees or performs drug administration, and other activities as delegated and required.
   7. In collaboration with the responsible teams, monitors that all study-related activities are conducted according to protocol, SOP, and applicable regulations.
   8. Reviews and manages clinic updates, Adverse Event (AE) or Serious Adverse Events (SAEs) reporting, study logs and tracker, quality control, and Monitor findings.
   
   
3. Post-Clinic/Close-Out Activities
   
   
   
   1. Coordinates resolution and/or address QC, monitor, CRF, or other internal/external findings
   2. Reviews and/or oversees close-out of study documentation, deviation reporting, CRF completion and sign-off, and other study-related reports/documentation.
   3. Reviews and updates TMF documentation
   4. Finalizes study and/or volunteer logs.
   5. Ensures completion of other close-out activities as required (return of study supplies, IRB reports, archiving, etc.)
   
   
4. Responsible for monitoring subjects' compliance throughout the trial and address day-to-day subject or study issues and escalate as appropriate.
5. Prepares for and participates in sponsor/monitor/QA audits.
6. Provides accurate and timely project status updates to Project Managers and sponsor.
7. Collaborates within and between teams during process improvement exercises, SOP creation and/or revision, internal and external meetings, and other company-related initiatives and goals.
8. Accommodates flexible schedule (available days, afternoons, nights, and weekends).
9. Performs other work-related duties as assigned. Minimal travel may be required (up to 25%).

QUALIFICATION REQUIREMENTS (please indicate if 'preferred')

University Degree such as R.N. or Bachelor of Science Degree. Clinical Research certification an asset. A minimum of 2 years experience in clinical research, preferably in coordination of clinical research projects. Good knowledge of regulations, ICH GCP, privacy, and applicable guidelines. Good assessment, problem solving, planning, and evaluation skills. Possesses good time management, detail-oriented, and able to multi-task. Ability to provide clear and focused leadership. Good interpersonal and communication skills with a team focus. Knowledge of SOP writing. Ability to anticipate problems and provide solutions in a timely manner. Ability to coordinate multiple clinical research projects with competing deadlines. Proficiency in computer software programs (e.g. Word, Excel, Power Point)

Qualifications

QUALIFICATION REQUIREMENTS (please indicate if 'preferred')

University Degree such as R.N. or Bachelor of Science Degree. Clinical Research certification an asset. A minimum of 2 years experience in clinical research, preferably in coordination of clinical research projects. Good knowledge of regulations, ICH GCP, privacy, and applicable guidelines. Good assessment, problem solving, planning, and evaluation skills. Possesses good time management, detail-oriented, and able to multi-task. Ability to provide clear and focused leadership. Good interpersonal and communication skills with a team focus. Knowledge of SOP writing. Ability to anticipate problems and provide solutions in a timely manner. Ability to coordinate multiple clinical research projects with competing deadlines. Proficiency in computer software programs (e.g. Word, Excel, Power Point).