Sub-Investigator

Job Details

Columbus, OH

Description

POSITION FUNCTION

The Sub-Investigator supports the Principal Investigator in the oversight and conduct of the research study at the study site.

ORGANIZATION SUMMARY

Centricity Research is a clinical research organization with more than 20 sites, access to over 1.6 million patients and participants, 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 study participants, 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.

Centricity Research recognizes the following core values as being essential characteristics for individual and collective success:

Quality

Care

Be the Change You Seek

One Team

Grow for Good

Own It

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

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

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