Type of Position: Full time/ Permanent

Department/Business Unit: Clinical Operations

Definition: The Associate Director of Clinical Operations (CRA) will manage a group of Clinical Research Associates and will coordinate their monitoring activities. She/he will assists the COO in overseeing the general management of the Clinical Operations department’s staff and services. Contributes to the ongoing improvement of the overall efficiency of the Clinical Operations department including interdepartmental relation. Collaborates cross-functionally with the Director, Clinical Operations to ensure client’s satisfaction.

Essential Functions: The following duties represent the principle job duties however they are not all inclusive:

• Assists with developing and executing the departmental objectives
• Collaborates with Business Development department in developing Service Agreement proposals and participates in bid defense presentations
• Tracks staff resource utilization, assists with allocation of clinical study/project to appropriate staff and ensures adequate staff support of each clinical study/project
• Attends Internal and Sponsor Kick-Off meetings
• Assures that clinical studies/projects are conducted in compliance with Service Agreement (including deliverables and timelines), and applicable regulations and Standard Operating Procedures
• Provides leadership to the site management team, project management, oversight to plan and conduct clinical studies/projects concurrently
• Oversees planning, preparation and presentations at Investigator’s Meeting
• Participates in the quality control processes Approves Project Plans, Monitoring Plans, CRA Quality Oversight Plans, Site Releases, IT Requests, Purchase Orders, and Vacation Requests
• Provides support and direction to project team members, helps with problem resolution, and provides assistance and guidance to Project Managers and Clinical Research Associates.
• Liaises with sponsor and site representatives, as required to ensure customer satisfaction
• Ensures that clinical studies/projects status, change orders and team members’ time are tracked using the Project Management software
• Liaise with other departments to ensure timely deliverables, as required
• Contributes to the development of department and interdepartmental Standard Operating Procedures
• Analyzes and recommends improvements to current systems and processes to ensure consistency and increase efficiency in the conduct of clinical studies/projects
• Develops and/or implements tools to improve efficiency in the conduct of clinical studies/projects
• Builds talent and capabilities of staff through proactive coaching, mentoring and development opportunities
• Recruits employees to ensue department is staffed with qualified personnel
• Coordinates and supervises staff providing constructive feedback
• May also assure the management and lead the project team for one or more concurrent clinical studies/projects from initiation to closing as per Project Manager Job Description or Clinical Research Associate Description.

Skills and Qualifications:

Knowledge of:

• CRO and Life Science Industries
• Project management principles
• Quality assurance principles
• Business planning and financial budgeting
• MS Office
• ICH Guidelines
• Good Clinical Practices
• Good Documentation Practices
• FDA 21 CFR Part 11 for handling of electronic records requirements

Ability to:

• Maintain and exhibit discretion at all times when handling confidential information
• Lead a multi-disciplinary project team
• Make independent decisions and use good judgment
• Plan, organize, and prioritize tasks efficiently
• Communicate effectively orally and in writing
• Assume multiple and concurrent tasks and responsibilities
• Establish and maintain cooperative and effective working relations with fellow colleagues and employees
• Communicate effectively with client, site and supplier representatives
• Demonstrate integrity, respect, professionalism, commitment, accountability

Experience and Education:

• M.Sc. in Life Sciences or equivalent B.Sc. with relevant work experience in clinical research
• Relevant experience in CRO and/or biotech or pharma companies with monitoring background is a must.
• Bilingual is a must

Definition: Under the direction of the COO, the Clinical Research Associate is responsible for monitoring clinical studies at investigational sites. Monitors those sites in order to ensure that studies are carried out according to protocol and in accordance with JSS SOPs, applicable regulations and the principles of Good Clinical Practice.

Essential Functions: The following duties represent the principal job duties however they are not all inclusive:

Familiarity with JSS Medical Research SOPs and appropriate regulations such as Health Canada

Independently or in consultation with the Sponsor/JSS/CRO, coordinate all the necessary activities required to setup and monitor a study

Conduct pre-study visit

Assess study site to ensure, facility, patient population and staff are sufficient to support the protocol.

Meet with PI and staff to review study requirements (protocol, CRFs, Sponsor policy and procedures, investigator responsibilities, staffing and patient recruitment)

Conduct study initiation visit

Confirm appropriateness of the IRB/ethics committee as per GCP

Train the site on the CRF completion, on the protocol and safety reporting procedure

Collect and forward all required study documentation to Sponsor or JSS.

Document visit and send a copy of the report to the site

Conduct routine monitoring visits

Review protocol compliance.

Verifies the source data and ensures that it is accurately reflected in the Case Report Form

Resolve questions by Investigator/Staff and ensures the validity of the queries sent to the site by the data management group

Check/inventory clinical supplies

Review communication with the IRB/ethics committee

Review study product accountability

Ensure that all consents (if applicable) are signed by the patient prior to study entry

Follow-up on previous issues

Collect all regulatory documents such as CV, MD licenses, IRB approvals etc…

Conduct close out visits to include:

Review and collect remaining CRFs.

Ensure that the Ethics committee has be advised of the termination of the study

Retrieve clinical supplies and any other study materials

Review investigator’s files to ensure that all documents are in order and ready for audit or inspection

Review retention policy and publication procedure

Review any follow-up requirements that may be required.

• Keep the project manager informed

Skills and Qualifications:

Knowledge of:

• Requirements of Good Documentation Practice
• Applicable Regulatory Requirements pertaining to clinical research
• FDA 21 CFR Part 11 for Handling of Electronic Records

Ability to:

• Communicate effectively in spoken and written French (Quebec CRAs only) and English
• Travel up to 80% of the time during peak study periods (international and domestic: fly and drive)
• Maintain and exhibit discretion at all times when handling confidential information
• Make independent decisions and use good judgment
• Review and evaluate clinical data
• Plan, organize, and prioritize tasks efficiently
• Communicate effectively orally and in writing
• Assume multiple and concurrent tasks and responsibilities
• Establish and maintain cooperative and effective working relations with sites
• Demonstrate behaviors that are shared at JSS Medical Research: integrity, respect, professionalism, commitment, accountability

Experience and Education:

• Must have a minimum of a B.Sc. degree.
• Minimum of two years previous field monitoring experience