Senior Laboratory & Data Coordinator

Position Summary

Under the direct supervision of the Site Manager, the Senior Laboratory and Data Coordinator – Bronx Prevention Center coordinates and oversees all data entry and laboratory activities at the Bronx Prevention Center. Ensures adherence to and follows all applicable research protocols, standard operating procedures (SOPs), policies, and relevant regulations. Works closely with the site manager and clinicians for all activities regarding lab and data management for new protocol readiness. Ensures other research staff are trained on data entry and Quality Control / Quality Assurance activities along with the Site Manager and Clinicians.

Responsibilities

• Coordinate and oversee day-to-day aspects of data entry and QC site activities, including. Ensure site complies with study protocols as well as all relevant procedures, policies, and regulations. Act as the point of contact for new staff in entering data and tracking timeliness of data and assisting Study Clinician to track AEs and other data points. 5%
• Manage and oversee data management staff. This includes laboratory procedures per protocol, such as collecting, documenting, processing and shipping samples, and quality control and continuous quality improvement. 5%
• Oversee the training of research staff on data entry and lab procedures and developing and updating SOPs for all research protocols and assist with the preparation of progress reports and presentations, as required by funding agencies and regulatory bodies. 5%
• Maintain confidentiality of study participants and adhere to principles of Good Clinical Practice (GCP), Good Clinical Laboratory Practice (GCLP) and International Air Transport Association (IATA) certification. 5%
• Use Laboratory Data Management Systems (LDMS) to track specimens and assist with shipping specimens. Check laboratory room and freezer temperature at least twice a day. Maintain cleanliness of laboratory room. 5%
• Oversee lab manager maintain laboratory research files and document results of test performed in accordance with study protocols and assist Lab Manager with maintaining and replenish laboratory inventory; keep records of inventory usage and order new laboratory supplies when needed. 5%
• Assist study clinicians and Quality Control (QC) charts daily and sign off in RAVE and attend weekly QC/QA meeting with the study clinicians and record and distribute minutes. 5%
• Contribute to and participate in the Performance/Quality Improvement activities of the research site: perform data collection and analysis; implement and ensure compliance with risk management and claims activities; and support and actively participate in Continuous Quality Improvement (CQI). 10%
• Work collaboratively with the other staff to ensure data is collected in a timely manner managed and reported clearly, accurately, and securely for all studies. 10%
• Oversee data entry for all the studies and review source doc and monitors data prior to entry to assure accuracy of the data and respond to queries in a timely manner. 10%
• Oversee the creation of QC tools and updating the tools in a timely manner. 5%
• Works closely with clinical staff in timely data submission meeting the funders requirements per protocol/network and monitoring monthly data monitoring reports. 5%
• Coordinates monitoring visits, including preparation, follow-up on recommendations and other findings and participates in development of plans of correction when needed. 5%
• Ensure site compliance with study protocols (data management), all relevant lab procedures, policies and regulations. Learn, understand and adhere to existing and new study protocols, Standard Operating Procedures and other appropriate regulations, procedures and policies. 5%
• Assist with other study procedures, Quality Control Quality Assurance (QCQA) activities, and administrative tasks at the study site. 5%
• Establish and maintain positive relationships and interacts professionally, courteously, and appropriately with participants and visitors to the research site and other employees working at the site. Behave in a manner consistent with maintaining and furthering a positive public perception of the research site and its employees. 5%
• Perform other related tasks as assigned. 5%

Minimum Qualifications

• Requires a bachelor’s degree or equivalent in education and experience, plus three years of related experience.

Preferred Qualifications

• Minimum 2 years of experience conducting laboratory assays

• Demonstrated experience organizing and implementing disparate workflows to meet organizational schedules and requirements.

• Excellent oral, written and interpersonal skills.

• Excellent phlebotomy skills.

• Experience with obtaining and processing laboratory specimens and running lab tests.

• Bilingual (Spanish/English preferred)

• Experience with Peripheral Blood Mononuclear Cell (PBMC) processing.

• Certifications in Good Laboratory Practices (GLP), Human Subjects Protection (HSP), Good Clinical Practice (GLP) and International Air Transportation Association (IATAA).

• Familiarity with Laboratory Data Management System (LDMS)

Other Requirements

• There are no domestic or international travel requirements associated with this position.