Assistant Operations Manager

4 days ago

Halifax, Canada Centricity Research Full time

POSITION FUNCTION

The Assistant Operations Manager is responsible for the coordination and administration of clinical trials under the direction of the Operations Manager and the Investigators. The Assistant Operations manager will develop, implement, and coordinate research and administrative procedures for the successful management of clinical trials.

ESSENTIAL FUNCTIONS

Protocol and Safety:

- Ensure the safety and welfare of study participants
- Conduct the study as per protocol, GCP, and SOPs including screening study participants based on protocol inclusion/exclusion, scheduling visits, and obtaining study specific assessments e.g. vitals
- Be knowledgeable of study protocol to ensure all study activities are completed correctly

Recruiting, Screening, and Enrolling Study Participants:

- Assist in local recruiting efforts for clinical trials
- Support to ensure operationally ready to achieve recruitment plans and objectives
- Lead regularly scheduled research meetings with focus on recruitment and retention, study and site updates, and ensuring engagement of CRP and Investigators
- Support site level physician engagement ensuring site recruitment and support

Study Visit Completion:

- Perform delegated research and administrative procedures to assist in conducting clinical studies under the direction of the Investigator
- Perform ECGs, vital signs, meal distribution, study participant monitoring, and other tasks as required by protocol/site
- Perform phlebotomy, point of care testing, sample collection, processing & shipping as required by protocol/site
- Obtain all necessary documentation as required by the protocol
- Timely and accurate completion of source, data, CRFs, queries and CTMS

Safety Reporting & Data Integrity:

- Verify input data and timely documentation regularly and accurately
- Support the review of source docs and other study documents, as required
- Support audit preparation for any site inspections
- Perform regular quality control (QC) checks and other QC tasks as deemed necessary

General:

- Abide by GCP, SOPs, company guidelines, and local healthcare privacy regulations
- Communicate study updates and learnings with applicable staff
- Communicate effectively both internally and externally
- General site level support
- Travel and support applicable sites within the region
- Ensure confidentiality
- Support feasibility review and submissions, where required
- Conduct/support PSV
- Work independently with little to no supervision

Management:

- Support quarterly recruitment targets and support efforts to achieve site/company KPIs
- Support admin to verify operations metrics are available and accurate
- Support in recruiting and hiring of CRPs
- Supervise, train, mentor and develop CRPs
- Serve as a resource for CRPs
- Train employees and model continuous improvement
- Provide ongoing feedback and coaching to all CRPs
- Conduct reviews/check-ins as outlined by HR and/or Operations Manager
- Approve time off request and timecards
- Anticipate issues and needs for the site based on trends seen at the site level
- Fostering cohesiveness at all levels of the company
- Unify site specific culture and Centricity fundamentals
- Other supervisory responsibilities as assigned

EDUCATION/EXPERIENCE

**Minimum**:

- Canada: College/University degree or equivalent in life sciences related field
- US: HS/GED
- At least 1 year of Centricity Research experience OR (External applicants) at least 3 years working in clinical research and 1 year of management experience

**Preferred**:

- Post-secondary education in a clinical research program

CORE COMPETENCIES/SKILLS
- Prerequisite (Essential):_
- Excellent communication skills (verbal and written)
- Excellent computer skills (MS Word, Excel and Outlook)
- Attention to detail
- Ability to manage time efficiently
- Self-directed
- Teamwork & Collaboration
- Proficient level of clinical, interpretive, and analytical skills with organizational skills for project planning
- Flexible & Adaptable
- Strong knowledge of ICH GCP, FDA & HC Division 5 guidelines
- Foundation:_
- Conflict resolution
- Receptive to feedback
- Empowering & Developing others
- Empathy Skills
- Planning and organizing skills
- Excellent problem-solving skills
- Achievement oriented
- Analytical ability
- Initiative
- Decision making
- Leadership:_
- Forward thinking
- Innovative
- Creative
- Strategic thinking
- Self confidence
- Strong interpersonal skills

PHYSICAL DEMANDS
- Physical demands include but not limited to prolonged sitting, light lifting, standing, reaching, walking, and bending.
- Frequently required to complete work on the computer in a seated position
- May be required to lift light boxes (10 - 20lbs)

WORKING CONDITIONS
- Modern medical office environment or home office environment
- Required to follow OSHA and CCOHS guidelines, in addition to other local healthcare regulations
- Required to perform duties in relation to HIPAA, PIDEDA, and other local pr

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