Clinical Studies Specialist II
Job Title: Clinical Studies Specialist II
Member of the clinical team responsible for conducting Phase I-IV studies according to Federal Regulations and ICH guidelines. “Trial Master File Owner” responsible for managing and ensuring inspection readiness of clinical documentation / master files. Ensures real-time inspection readiness of clinical documentation / TMF by performing quality control (QC) of the TMF/artifacts to ensure completeness, document quality and timeliness of upload of artifacts to the TMF. Representative on study team(s) with ownership of the study Trial Master File (TMF). Develops and maintains study-specific TMF structure documentation. Provides TMF support for audits/inspections.
NOTES FROM MANAGER:
I think we are targeting resourceful learners who are:
- Adept with technology
- Highly organized
- Strong communicators
- Effective at motivating others
- 1-3 Years Experience Level.
1) What hours and days will this person be working? Monday – Friday. Hours can start at 6:30 AM. 8 hours on top of a lunch. Lunch can be 30 minutes – 1 hour. They can choose their start time as long as it’s consistent on a day-to-day basis.
2) What are the top 5 skills/requirements this person is preferred to have?
a. Preferred Skill 1: Tech savvy regarding clinical trial management systems
b. Preferred Skill 2: Strong written and oral communication skills
c. Preferred Skill 3: Quality Assessment / Quality Systems
d. Preferred Skill 4: Highly organized
e. Preferred Skill 5: Experience working in documentation systems
3) What years of experience, education, and/or certification is required; Bachelors Degree required (Experience in any one of the 6 areas listed fulfills all requirements):
a. Prior research site experience as a Research Coordinator or Regulatory Coordinator
b. Prior CRO experience as an in-house monitor
c. Quality and Compliance in GCP
d. Trial Master File experience
e. Audit/ Inspection preparation (GCP)
f. Prior experience as CRA
4) What is the environment that this person will be working in (i.e. group setting vs individual role)? Both
5) Is any testing required for this role? No
6) Does this position offer the ability to work remotely on a regular basis or is it an on-site role? On-site If remote opportunity exists, what are the options (i.e. 1 day remote, 4 days on-site)? 2 days after demonstration of ability to work independently. Usually after 3 – 6 months.
7) Other notable details about the environment from the hiring manager about this role? No
8) What positions/background experience do you feel are successful in this role? TMF, Clinical, Quality Assurance, Documentation, Inspection prep