Medical Investigator

SPAULDING CLINICAL aims to be the clinical research organization by which all others are measured. Pioneering in our approach to redefining how the industry perceives and achieves success; passionate in our pursuit of ingenious solutions that mitigate risk; loving in our care for our volunteers, customers and employees; and heroic in our ambitions to ensure the health and safety of people around the globe - Spaulding Clinical is taking research beyond results to create a marketplace of safer drugs.

Here at Spaulding Clinical Research we are looking for a Medical Investigator to join us at a per diem/pool capacity.

Schedule: 2 -3 days a week. Hours may vary between 7am-7pm. There is an on call rotation which includes every third weekend/Holiday.

Job Summary:

As Medical Investigator at Spaulding’s Clinical site, you will be responsible for the conduct of clinical trials according to study protocols, review of safety data, and monitoring the safety of study participants enrolled into clinical trial protocols.

Essential Duties and Responsibilities:

• Responsible for protecting the rights, safety and welfare of study participants.
• Responsible for ensuring the clinical trial is conducted according to the investigational plan and all applicable regulations.
• Provide medical and scientific feasibility of all new sponsor inquiries.
• Review and evaluate protocols and provide clinical and scientific support.
• Liaise with sponsor regarding study design and site capabilities.
• Interact with regulatory bodies as relevant to clinical operations.
• Attend study initiation meetings.
• Present protocols at IRB meetings, as required.
• Assist Clinical Operations and sales/marketing efforts with Sponsor visits.
• Perform pre-study physical examinations, review screening data, including subject medical histories, ECGs, radiographic studies, laboratory studies, and any other ancillary tests required per study protocol to ensure volunteers are medically and mentally fit upon entering the study.
• Review of subjects’ eligibility based upon protocol inclusion and exclusion criteria.
• Review, initial and date all safety related data in a timely manner to include laboratory studies, ECGs and all other safety data as dictated by the study protocol.
• Coordinate with Medical Operations and Clinical Operations staff to ensure proper medical coverage for clinical trials.
• Perform on-study and post-study physical examinations to ensure the physical and mental well-being of volunteers is undiminished at the end of the study.
• As needed, assist with training of clinic associates on ECG procedures, manual vitals procedures and assessment skills.
• Safety monitoring – Monitor, review, and track adverse events and serious adverse events. Institute medical treatment as needed.
• Inform IRB and Sponsor as appropriate of relevant events.
• Review and sign CRFs/eCRFs at the conclusion of the study.
• Delegate the above as appropriate.
• Act as Principal Investigator/Sub-investigator as assigned.
• Work with Sponsor(s) to determine better go forward solutions and operations to improve synergies with customer on future studies.
• Weekend and off-hours work as necessary.

The Statements made in the job description are intended to describe the general nature and level of work being performed by people assigned to this job. These statements are not intended to be an exhaustive list of all responsibilities, duties and skills required of people assigned to this job.

Skills/Qualifications:

• Ability to read, write, and interpret the English language.
• M.D., D.O, Nurse Practitioner or Physician Assistant
• U.S. Board Certification
• Active license to practice in the state of Wisconsin, or an active license that is transferable to Wisconsin within 3 months.
• If unlicensed practitioner, must work within realm of education but not outside of scope of practice, i.e., cannot prescribe, cannot treat.
• Strong interpersonal and leadership skills, self-motivation, and high personal integrity and ethics required.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Ability to sit, stand, walk, reach with hands and arms, and use hands along with fingers, to handle or feel.
• Ability to lift and/or move up to 25 pounds.
• Specific vision abilities required by this job include clarity of vision both near and far.
• Ability to identify and distinguish colors.

Hazards:

• Potential for exposure to toxic or caustic chemicals
• Potential for exposure to blood borne pathogens

Education and Experience:

• Currently licensed in the state of Wisconsin as a Nurse Practitioner, Physician Assistant, DO or MD.
• Training in Basic Life Support and Advanced Cardiac Life Support.
• Board certified or Board eligible in a primary care specialty.
• Preferred clinical research experience within a CRO or Phase I research facility.
• Preferred experience conducting Phase I clinical trials.