Employment Type: Part Time
Posted on: 2017-10-29
Carey-Wang Clinical Research Coordinator Part Time in Westmount, QC
Branch Westmount QC CA
Clinical Research Coordinator
Provides appropriate training and tools for study team members. Maintains documentation of training. Documents date of training and signatures of study…
Study Coordinator at Siena Medical Research Corporation (Carey/Wang)
We are currently looking for a friendly and independent study coordinator to coordination, manage and conduct clinical research under the supervision of Dr. Wayne Carey. This person will be acting as main and only study coordinator at the clinic with the help of our Research Nurse. Working independently and part of a team is a must. We are a small team and therefore group dynamic is key.
As the study coordinator your tasks will include but are not limited to:
- Coordinates with Principal Investigator to help ensure that clinical research and related activities are performed in accordance with regulations.
- Assists the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to (but not limited to) protocol requirements, schedule of visits, execution of research plan. Maintains documentation of training.
- Assists Principal Investigator to assure that all key personnel or persons ‘engaged’ in the research project have met training requirements in accordance with regulations.
- Coordinates and facilitates monitoring and auditing visits. Notifies appropriate sponsors of external audits by FDA and/or Health Canada.
- Collaborates with PI and institution to respond to any audit findings and implement approved recommendations.
- Cooperates with sponsoring agency compliance and monitoring efforts related to human research participant protection and reports instances of noncompliance to the IRB.
- Creates and modifies SOPs as needed.
- Manages and facilitates invoicing and incoming payments from sponsors.
Preparation of New Study Proposal
- Assists the PI in study feasibility assessments as requested.
- Collaborates with the PI to prepare a categorized budget and justification. Confirms accuracy and completeness of budgeted costs.
Protocol Preparation & Review
- Reviews and comprehends the protocol.
- Attends investigator meetings as required or requested by the PI.
- Collaborates with the PI to prepare IRB and any other regulatory submission documents as required by the protocol.
- Prepares other study materials as requested by the PI. These study materials include, but are not limited to, the informed consent document, case report forms (CRFs), enrollment logs, and drug/device accountability logs.
- Establishes and organizes study files, including but not limited to, regulatory binders, study specific source documentation and other materials.
Conduct of Research
- Reviews and develops a familiarity with the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections.
- Assists PI in communication of study requirements to all individuals involved in the study. Provides appropriate training and tools for study team members. Documents date of training and signatures of study personnel trained on study specific training log.
- Collects documents needed to initiate the study and submit to the sponsor (e.g., FDA Forms 1572, CVs, etc.).
- Works with the PI to develop and implement recruitment strategies in accordance with IRB requirements and approvals.
- Conducts or participates in the informed consent process including interactions with the IRB and discussions with research participants, including answering any questions related to the study. Obtains appropriate signatures and dates on forms in appropriate places. Assures that amended consent forms are appropriately implemented and signed.
- Screens subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or exclusion.
- Coordinates participant tests and procedures.
- Collects data as required by the protocol. Assures timely completion of Case Report Forms.
- Maintains study timelines.
- Maintains adequate inventory of study supplies. If handling investigational drugs/devices, follows the sponsor protocol Investigational Drug/Device Accountability.
- Completes study documentation and maintains study files in accordance with sponsor requirements.
- Retains all study records in accordance with sponsor requirements and federal regulations.
- Maintains effective and ongoing communication with sponsor, research participants and PI during the course of the study.
- Works with the PI to manage the day to day activities of the study including problem solving, communication and protocol management.
- Follows site specific SOPs as well as protocol.
- Promotes the ethical conduct of research.
- Assists Principal Investigator with scientific and compliance reporting requirements in accordance with Federal regulations and sponsoring agency policies and procedures.
- Assists the Principal Investigator in submission of accurate and timely closeout documents to applicable federal agencies and the sponsoring agency in accordance with federal regulations and sponsoring agency policies and procedures.
- Arranges secure storage of study documents that will be maintained according to federal regulations or for the contracted length of time, whichever is longer.
Working hours are Monday to Wednesday 8h-17h, flexible days if absolutely necessary. Full time training will be required. Training is to begin end of November 2017 for you to take over the position in January 2018.
Skills and Requirements
The skills required are:
- excellent computer skills
- knowledge of Microsoft word, excel, and outlook
- any eCRF knowledge
- team worker
- take initiative when needed
The requirements for the job are:
- Bachelor’s degree in a science related field
- 1-2 years clinical research experience is mandatory
- English (spoken and written) and French (spoken) mandatory, other languages are an asset
Please send us your CVs as we look forward to meeting you.
Job Type: Part-time
- Clinical Research: 1 year