JOB DESCRIPTION |
Position Title: | Sub-Investigator |
Department: | Research Operations |
Reports To: | CMO or designee ie. Medical Director |
Direct Reports: | Designated CRPs (varies depending on the site) |
POSITION FUNCTION |
The Sub-Investigator supports the Principal Investigator in the oversight and conduct of the research study at the study site. |
ORGANIZATION SUMMARY |
Our Passionate Cause: Revolutionizing Research & Changing Lives! Organization Profile: IACT Health, LMC Manna Research, and True North Clinical Research joined forces in late 2021 to become Centricity Research. Centricity Research is a clinical research organization with more than 40 sites, access to over 1.6 million patients, and more than 150 active investigators across Canada and the southeastern United States. Our name, Centricity Research, was purposefully chosen to signify the fact that we are customer centric. Our patient volunteers, sponsors, CROs, and physicians are the cornerstone of our business. The name Centricity Research also highlights the fact that our organization has earned a position of prominence and importance within the industry. We aim to build and nurture strong, trusting relationships with all audiences, and being customer-centric is embedded within our company culture. FUNdamentals: Centricity Research recognizes the following core values as being essential characteristics for individual and collective success: - Dream Big
- Go Above and Beyond
- Do The Right Thing
- Be Curious
- Have Fun
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ESSENTIAL FUNCTIONS |
- Ensure the safety and welfare of study participants
- Delegated to supporting the PI in oversight and conduct of the clinical trial
- Abide by GCP, SOPs, company guidelines, and local healthcare privacy regulations
- Perform delegated Sub-Investigator duties as per protocol and delegated acts, which may include, but not limited to: making trial related medical decisions, maintain adequate study records, consent participants, determine eligibility, review and assess vitals, ECGs, labs, or any other diagnostic reports, assessing AEs/AESIs, SAEs, etc.
- Familiarity with the appropriate use of the investigational product(s) as described in the protocol and in the current Investigator's Brochure and monitor any safety reports
- Instruct and counsel patients and their families;
- Involve them in informed decision making with regards to their illness, injury, therapeutic and diagnostic procedures, treatment regimens, normal growth and development, health maintenance or enrollment in clinical research
- Assist CRPs in enrolling patients into clinical trials and supporting any physician outreach in the communities and recruiting efforts
- Facilitate referrals of patients to other medical providers, medical facilities or other health/social service agencies when appropriate as per the delegation of the supervising physician
- Facilitate and promote relationships with local physicians and their staff in order to increase referrals
- Perform traditional clinical skills
- Accurately complete documentation
- Monitor and maintain patient flow and workflow promoting professionalism, patient confidentiality, blinding parameters, and best medical practices
- Assist in the development or revision of office protocols to promote ongoing quality initiatives
- Attend Investigator’s meetings and other educational conferences as deemed appropriate by supervising physician
- Perform or delegate daily organizational tasks as defined in the office
- Support in recruiting and hiring of CRPs, as applicable
- Train employees and model continuous improvement
- Supervise, train, mentor and develop CRPs
- Conduct reviews/check-ins as outlined by HR as applicable
- Approve time off request and timecards as applicable
- Work independently with little to no supervision
- Other responsibilities as assigned
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EDUCATION/EXPERIENCE |
Minimum: - Canada: Bachelor of Science in Physician Assistant Studies
- Certified through CCPA or NCCPA
- Member of CAPA
- US: Master of Science – Nurse Practitioner Program/Physician Assistant Program
Preferred: - BLS and ACLS Certified in preferred
- At least 1 year of Medical or Clinical Experience
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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
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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)
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WORKING CONDITIONS |
- Modern medical office environment.
- Required to follow all healthcare industry OHSA and OSHA guidelines
- Required to perform duties in relation to PHIPA, HIPAA, PIDEDA
- Some positions may require overnight/weekend hours
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BENEFITS |
- Opportunities to work with internationally renowned physicians
- Comprehensive health benefits, competitive salary
- RRSP and 401(k) contribution matching
- Continued opportunities for growth & development; yearly education allowance
- Paid holiday closures and employee appreciation days off
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