Opportunity for a clever and enthusiastic individual to make an important contribution to the Brooks mission by working with the Brooks Center for Innovation. The Clinical Research Coordinator I (CRC-I) participates in a variety of complex activities involved in the collection, compilation, documentation and analysis of clinical research data for assigned protocols and assists in ensuring current and accurate reporting and tracking information is maintained for assigned studies. Under the direction of the Principal Investigator(s), Research Manager, Senior Research Associate or other senior level staff the CRC-I may coordinate and perform study specific regulatory processes and procedures or assist other study personnel in doing so. The CRC-I may also conduct study related recruitment, assessments, measurements or interventions as appropriate. The CRC-I may be assigned direct responsibility as the coordinator for one or more projects and may also have general responsibilities for one or more additional projects.
SUPERVISES: Non-supervisory
Job Responsibilities:
Assist in preparing for study monitoring/auditing visits
Assist study personnel in conducting study procedures
Conduct informed consent
Conduct initial screening calls/visits with potential participants
Document and communicate of AE/SAEs to appropriate study personnel
Identify situations when involvement of primary investigators is needed.
Initiate and follow through with experimental protocols independent of primary investigators.
Input data and perform documentation in accordance with study procedures
Maintain study documentation in accordance to rules and regulations governing research
Maintain study metrics in adherence with reporting procedures
Monitor currency of study personnel's training and certifications
Participate in Center for Innovation initiatives
Plan study sessions and ensuring availability of required resources
Prepare documents and equipment/space prior to study visits
Prepare lists of potential participants for screening
Read and extract relevant information from medical records.
Schedule screening calls/visits
Schedule study visits in accordance with protocol
Serve as primary contact for general study inquiries
Submit requests for medical records
Assist VP, Clinical Integration and Research in developing research contracts and preparing/submitting IRB documents.
Work with the Center for Innovation team in conducting literature reviews for relevant research topics
Job Qualifications:
Minimum of a Bachelor's degree. At least 1 year of previous research experience is desired.
Strong and demonstrable planning, management, organization, communication, collaborative and analytical skills are required.
Basic Life Support (CPR) required.
Current knowledge of state and federal rules, regulations, and standards governing clinical research is preferred.
Proficiency with Windows and web-based applications required.
Requires leadership skills and must demonstrate high level of self-motivation and self-regulation.
Must demonstrate excellent verbal/written communication skills.
Disclaimer: This job description describes the general nature and level of work only. It is not an exhaustive list of all responsibilities, duties, and skills. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice.