Job Description

1. Communication and Coordination:

o Check Emails and Voicemails: Start the day by reviewing emails and voicemails. Look for responses from potential funders, trial candidates, or medical professionals.

o Coordinate with Key Personnel: Collaborate with the Principal Investigator (PI), department, and central administration to ensure that clinical research activities comply with federal regulations and university policies.

2. Study Preparation and Administration:

o Feasibility Assessments: Assist the PI in assessing the feasibility of conducting the study at specific sites.

o Standard Operating Procedures (SOPs): Develop SOPs for study-related activities.

o Database Programs and Forms: Create necessary study forms and database programs for data collection and entry.

o Training: Train medical assistants and nurses on study protocols.

o IRB Correspondence: Review and prepare correspondence with the Institutional Review Board (IRB) for submissions, amendments, adverse events, and progress reports.

o Regulatory Compliance: Maintain regulatory documents as per sponsor and IRB protocols.

3. Participant Interaction and Study Activities:

o Eligibility Screening: Screen potential subjects for study eligibility.

o Recruitment and Retention: Coordinate recruitment efforts and ensure retention of research subjects.

o Informed Consent: Participate in the informed consent process with study participants.

o Study Activities: Perform face-to-face and telephone assessments, medical records abstraction, and other study-related tasks.

o Specimen Handling: Collect, process, and ship specimens as needed.

o Appointment Scheduling: Coordinate diagnostic tests and procedures associated with study protocols.

4. Document Management and Accountability:

o Document Control: Ensure study documents are complete, current, and filed correctly.

o Time and Effort Recording: Accurately record time and effort spent on study-related tasks.

o Medication Management: Be responsible for study medication accountability and maintenance. This may involve dispensing study meds to patients, coordinating storage, and ensuring compliance with the study protocol.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com .

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Skills and Requirements

Must Haves:

   · 1+ years of Experience with clinical trials

     o Has to be independent- working on project by themselves

   · Industry Sponsored Clinical trial Experience

     o Family and drug/device studies

   · Patient Contact Experience

Have a car to get them to other locations * Psych and mental health

* Neurology

* Phlebotomy Experience

 Will get trained on this when there so make sure they are comfortable

*  CCRP Certified / Socra Certified

* CRO experience

* Epic Experience

* Working with research modules

* CITI trained

* EKG Experience

Experience with phase 1- phase 4 null

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to HR@insightglobal.com.