Clinical Trial Coordinator

EN

**JOB DESCRIPTION**:
An immediate full-time position (35 hours/week) is available in the research laboratory of Dr. Mark Eisenberg, at the Centre for Clinical Epidemiology of the Lady Davis Institute (Jewish General Hospital, Montreal, QC). Dr. Mark J. Eisenberg’s research focuses on the primary and secondary prevention of cardiovascular disease, with topics ranging from interventional cardiology to broad public health issues such as smoking and obesity. His latest randomized controlled trial, the Aggressive Smoking Cessation Therapy Among People at Elevated Cardiovascular Risk (ASAP) Trial, is a multi-centre clinical trial that assesses the efficacy, safety, and tolerability of aggressive smoking cessation therapy among people at elevated cardiovascular risk.

**PRIMARY RESPONSIBILITIES**:

- **Manage ASAP Trial**_
- Oversee implementation of the ASAP Trial protocol at the study sites
- Ensure compliance with ethical standards, Good Clinical Practice (GCP), and institutional policies
- Liaise with investigators, sponsors, and regulatory bodies to facilitate smooth trial operations
- Monitor enrollment targets and retention strategies to ensure timely completion of recruitment
- Coordinate submission of amendments, progress reports, and other regulatory documentation
- **Day-to-day coordination of the ASAP Trial**_
- Act as first line of contact for site study coordinators, investigators, and other site staff
- Manage the receiving and shipment of study drug and other study supplies
- Review submitted CRFs and coordinate appropriate site payments
- Track study timelines, budget and prepare periodic newsletters
- Recruit patients, preform patient follow-up and data entry
- Prepare for and support monitoring visits and audits
- **Other responsibilities**_
- Train and supervise research assistants or other support staff involved in the trial
- Maintain study supplies and ensure readiness of materials for each visit
- Participate in team meetings and contribute to ongoing process improvements
- Assist with data cleaning and query resolution in collaboration with the data management team
- Performing administrative duties as required

**Qualifications**
- Master’s degree in Epidemiology, Public Health, or a related discipline
- Experience in clinical research is an asset
- Strong writing and communication skills in both English and French
- Excellent interpersonal abilities and team collaboration skills
- Commitment to the role for a minimum of 2 years
- Exceptional organizational skills; detail-oriented and thorough
- Strong analytical and problem-solving capabilities
- Ability to work independently and as part of a multidisciplinary team
- Proficient in using computer software and digital tools for data entry, documentation, and communication

**Additional information**

**Status: P**ermanent, full-time (35-hours/week)

**Salary details**: Competitive (commensurate with experience and qualifications)

**Work shift**:Monday to Friday 8:30 am to 4:30 pm

**Work site**:Lady Davis Institute (Jewish General Hospital), 3755 Chem. de la Côte-Sainte-Catherine, Montréal

**CONTACT INFORMATION**:
Mark J. Eisenberg, MD MPH
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- FR

**DESCRIPTION DU POSTE**:
Un poste à temps plein (35 heures/semaine) est à pourvoir immédiatement au laboratoire de recherche du Dr Mark J. Eisenberg, au Centre d’épidémiologie clinique de l’Institut Lady Davis (Hôpital général juif, Montréal, QC). Les travaux du Dr Eisenberg portent sur la prévention primaire et secondaire des maladies cardiovasculaires, allant de la cardiologie d’intervention à des enjeux de santé publique tels que le tabagisme et l’obésité. Son plus récent essai contrôlé randomisé, ASAP (Aggressive Smoking Cessation Therapy Among People at Elevated Cardiovascular Risk), est un essai clinique multicentrique qui évalue l’efficacité, l’innocuité et la tolérance d’une prise en charge intensive du sevrage tabagique chez des personnes présentant un risque cardiovasculaire élevé.

**RESPONSABILITÉS PRINCIPALES**:

- **Gestion de l’essai ASAP**_
- Superviser la mise en œuvre du protocole de l’essai dans les sites participants
- Assurer la conformité aux normes éthiques, aux Bonnes pratiques cliniques (BPC/GCP) et aux politiques institutionnelles
- Assurer la liaison avec les investigateurs, les bailleurs de fonds et les organismes de réglementation pour des opérations fluides
- Suivre les cibles de recrutement et les stratégies de rétention afin de respecter les échéanciers
- Coordonner la soumission des amendements, rapports d’étape et autres documents réglementaires
- **Coordination quotidienne de l’essai ASAP**_
- Servir de premier point de contact pour les coordonnateurs-trices de site, investigateurs et autres membres du personnel des sites
- Gérer la réception et l’expédition du médicament à l’étude et des autres fournitures d’étude
- Examiner les FRC (formulaires de recueil de cas/CRFs) soum