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Sr. Clinical Research Associate
1. Assumes the role of a general or project-specific CRA as assigned by the Sr. CTM. Performs clinical trial site management activities for assigned sites as required to ensure appropriate contact and management of sites. Ensures study site compliance with the protocol, applicable SOPs, regulations and guidelines. The Sr. CRA is also expected to remain knowledgeable about current evolving regulations and guidelines concerning diagnostic, medical device and clinical trials in general, and will continue to receive clinical study monitoring training, both formal and on-the-job.
2. Specifically, the Sr. CRA:
· Monitors assigned study sites according to BD Diagnostics - Women's Health Standard Operating Procedures (SOPs), project-specific monitoring plans, and industry standards.
· Prepares site visit reports, confirmation and follow-up letters, and other monitoring documentation as required per company SOPs, study-specific Monitor Plans and industry standards.
· Performs monitoring visits at external and internal clinical research sites and/or laboratory research sites, including pre-study, initiation, routine interim monitoring, close out visits, and over-sight visits.
· Monitors the sites for Good Clinical Practices (GCP) compliance and compliance with the protocol and sponsor requirements including protocol adherence and adherence to site- and sponsor-specific SOPs.
· Reviews study subject data in the form of source documents and case report forms (CRFs) pertinent to the study, resolves data queries developed during the site monitoring process, and ensures investigational product accountability.
· Performs trial coordination activities and specialized clinical trial activities (e.g., contract management, Protocol Deviation reporting, Serious Adverse Event management) as requested by the Sr. CTM and per company SOPs, study-specific monitoring plans and industry standards.
· Assists with the tracking of patient enrollment data, monitoring visit data, CRF tracking, etc. as required to meet overall department and project goals and deadlines.
· Maintains study contact information, and assists in data management query resolution.
· Facilitates the timely distribution of adequate supplies, forms, equipment, study devices, etc. to assigned sites as required. Assists with the preparation and distribution of study materials to sites, CRAs, CRO personnel, etc., as required for the project.
· Understands assigned clinical protocols and all associated study materials. Is able to write business correspondence. Effectively presents information and responds to questions from internal personnel, Clinical Operations/Affairs project team members, and external vendor personnel, both in person and over the telephone.
· Effectively operationalizes clinical trial protocols at the site level to ensure compliance with the protocol and all applicable regulations and guidelines.
· Manages workload to ensure that quality monitoring is provided on time and within budget.
3. Under the general guidance of the Sr. CTM, interacts with external partners, which could include Contract Research Organization (CRO) personnel, to ensure the timely and cost-effective conduct of high quality clinical trials. When applicable, oversees the monitoring of sites by CRO personnel and contract/permanent CRAs, maintaining direct communication with the assigned CRA and reviewing trip reports and other relevant correspondence/documentation, as required, to ensure the study sites' compliance with the protocol and applicable SOPs, regulations, and guidelines.
Education and Experience Required:
· Minimum of a Bachelor's degree in Life Sciences or related field
· 4 - 6 years of direct clinical trial monitoring experience
· Experience monitoring for the medical diagnostics industry
· Knowledge of lab diagnostic testing
· Previous experience leading or mentoring others
· Excellent interpersonal skills, including the ability to perform successfully in a highly matrix environment
· High level of organization and ability to prioritize and handle multiple projects simultaneously
· Knowledge of Good Clinical Practices and other regulations and guidances relative to the conduct and monitoring of clinical trials worldwide
· Excellent written and oral communication skills, with the ability to articulate instructions
· Sound problem solving techniques, decision making processes, and ability to work efficiently and effectively with minimal supervision on routine work scopes
· Proficient in Microsoft Word, Excel, PowerPoint, Lotus Notes, and Internet
· Proven ability to interact effectively in a customer facing role
· Excellent attention to detail
Education and Experience Preferred:
· Graduate degree in life sciences or related field
· Experience with IVD (In Vitro Diagnostic) clinical trials strongly preferred
· Experience with laboratory monitoring
· Basic skills in electronic data capture applications
· Experience with trip report documentation and review
· ACRP and/or SoCRA certification
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