Clinical Research Coordinator I

About the role

Provides administrative and technical support to the Project Team. Supports audit readiness by ensuring files are reviewed according to the schedule detailed in the organization's SOP and department guidance document. Provides administrative support for site activation activities. Aids the development of the critical path for site activation within assigned projects in support of rapid site activations. Represents CRG personnel. May utilize local knowledge, organization systems, external site lists, and sponsor directives to develop and review site lists suitable for the strategic needs of feasibility activities and to provide local input into the site tiering process. May act as a buddy during the onboarding phase and provide training to new staff as needed.

Responsibilities

• Coordinates, oversees, and completes functions on assigned trial(s) activities as detailed on the task matrix.
• Performs department, Internal, Country, and Investigator file reviews as assigned, and documents findings in appropriate system(s).
• Ensures allocated tasks are performed on time, within budget, and to a high-quality standard. Proactively communicates any risks to project leads.
• Provides system support (i.e., Activate & eTMF) and ensures system databases are always current.
• Performs administrative tasks on assigned trials, including timely processing of documents sent to Client (e)TMF, performing (e)TMF reviews, distributing mass mailings and communications, and providing documents and reports to internal team members.
• Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation.
• Assists with coordination, compilation, and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites.
• Assists with study-specific translation materials and translation QC upon request.
• Maintains knowledge of and understands SOPs, client SOPs/directives, and current regulatory guidelines as applicable to services provided.
• Where applicable, conducts on-site feasibility visits (Asia Pac only).
• May support scheduling of client and/or internal meetings.
• May review and track local regulatory documents.
• May provide system support (i.e., Activate & eTMF) and support RBM activities.
• May support the maintenance of study-specific documentation and systems, including study team lists, tracking of project-specific training requirements, system access management, and tracking of project-level activity plans in appropriate system(s).
• Transmits documents to client and centralized IRB/IEC.
• Maintains vendor trackers.
• Supports the start-up team in Regulatory submissions.
• Works directly with sites to obtain documents related to site selection.

Requirements

• Bachelor's degree or equivalent and relevant formal academic/vocational qualification.
• BLS certificate required.
• Previous experience to provide the knowledge, skills, and abilities to perform the job (comparable to 0-2+ years).

Pay

The hourly pay range estimated for this position based in Minnesota is $25.00–$28.00. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy.

Benefits

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs.
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement.
• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy.
• Retirement and savings programs, such as a competitive 401(k) U.S. retirement savings plan.
• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount.

Schedule

Standard (Mon-Fri)

Environmental Conditions

Office