What are the responsibilities and job description for the Operations Manager position at Centricity Research?
POSITION FUNCTION
The Operations Manager is responsible for the training, growth, and development of CRPs at their applicable sites, overseeing the recruitment and retention of all study participants, and for ensuring quality standards and processes are consistent with the expectations of Centricity Research.
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
- Ensure operationally ready to achieve recruitment plans and objectives
- Lead regularly scheduled research meetings w/ 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
- Perform regular quality control (QC) checks and other QC tasks as deemed necessary
- Support audit preparation for any site inspections
General:
- Abide by GCP, SOPs, company guidelines, and local healthcare privacy regulations
- General site level support
- Support feasibility review and submissions, where required
- Conduct/support PSV
- Support study opportunities study planning, and study execution as per the job description for PM, when required.
- Communicate study updates and learnings with applicable staff
- Communicate effectively both internally and externally
- Timely phone, TEAMS and email communication and follow-through
- Develop, coordinate research and administrative procedures for the successful conduct of clinical trials
- Travel and support applicable sites within the region
- Ensure confidentiality
- Serve as a central point of contact for site escalated issues
- Work independently with little to no supervision
Management:
- Manage 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
- Train employees and model continuous improvement
- Conduct reviews/check-ins as outlined by HR
- Approve time off request and timecards
- Supervise, train, mentor and develop CRP
- Provide ongoing feedback and coaching to all CRP
- Transparency with the organic growth and future of the company
- Anticipate issues and needs for the site based on trends seen at the site level
- Actively develop and seek opportunities for regional and site-specific growth
- Serve as a resource for all teams
- 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
- Required by US and Canada: 2 years of clinical research experience
- CRC Certification through the Association of Clinical Research Professionals (ACRP)
- At least 1 year of Centricity 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 privacy regulations
- Some positions may require overnight/weekend hours
BENEFITS
- Opportunities to work with internationally renowned physicians
- Comprehensive health benefits, competitive salary
- RRSP or 401(k) contribution matching
- Continued opportunities for growth & development; yearly education allowance
- Paid holiday closures and employee appreciation days off
