Clinical Research Coordinator I

Work Schedule

Environmental Conditions

Job Description

Join us as a Clinical Research Coordinator I Provides administrative and technical support to the Project Team. Supports audit readiness by ensuringfiles are reviewed according to the schedule detailed in the organizations SOP and department guidancedocument. Provides administrative support for site activation activities. Aids the development of thecritical path for site activation within assigned projects in support of rapid site activations. RepresentsCRG personnel. May utilize local knowledge organization systems external site lists and sponsordirectives to develop and review site lists that are suitable for the strategic needs of feasibility activitiesand to provide local input into the site tiering process. May act as a buddy during onboarding phase andprovide training to new staff as needed.

Education and Experience:
Bachelors 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)

According to the specific role (Central or Local) coordinates oversees andcompletes functions on assigned trial(s) activities as detailed on the task matrix.
Performs department Internal Country and Investigator file reviews asassigned and documents findings in appropriate system(s).
Ensures allocated tasks are performed on time within budget and to a highquality standard. Proactively communicates any risks to project leads.
Provides system support (i.e. Activate & eTMF) and ensures system databasesare always current.
Performs administrative tasks on assigned trials including but not limited totimely processing of documents sent to Client (e)TMF as assigned performing(e)TMF reviews distributing mass mailings and communications as neededproviding documents and reports to internal team members.
Analyzes and reconciles study metrics and findings reports. Assists withclarification 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 andcurrent 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 of local regulatory documents.
May provide system support (i.e. Activate & eTMF). May support RBM activities.
May support the maintenance of study specific documentation and systemsincluding but not limited to study team lists tracking of project specific trainingrequirements system access management and tracking of project level activityplans in appropriate system(s).
Transmits documents to client and centralized IRB/IEC.
Maintains vendor trackers.
Supports start-up team in Regulatory submissions.
Works directly with sites to obtain documents related to site selection.

Compensation and Benefits

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. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on which includes:

• 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 our 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

For more information on our benefits please visit: Experience:

IC