Clinical Specialist

Baim Institute for Clinical Research; United States; On-site; USD 90,000 - 130,000; Full time

Job summary

The Baim Institute for Clinical Research is seeking a Clinical Specialist to support startup activities and develop Safety Management Plans and CEC operations for multiple studies. You will evaluate events, code and adjudicate safety data, and prepare narratives for regulatory submissions.

Responsibilities include data quality assurance, querying for missing information, and coordinating with project teams to ensure timely safety reporting and accurate trial interpretation.

Qualifications

• 3 years critical care nursing or equivalent clinical experience in cardiology or other areas depending on trial assignments required
• 1-3 years of safety experience
• Proficient in Microsoft Office
• Knowledge and understanding of clinical trials, safety reporting regulatory guidelines e.g. ICH and GCP guidelines
• Understanding and experience with MedDRA and WHODRUG coding Preferred
• Experience with Clinical Databases Preferred- InForm, RAVE Medidata, Mednet; EmpiricaTrace, ARGUS, Zelta preferred
• Strong preference for experience with Data Monitoring Committee management and medical writing experience

Responsibilities

• Perform project startup activities and development of Safety Management Plans and CEC Manual of Operations for assigned studies
• Perform event management for trials; evaluate eCRF/CRFs for medical content and reportability
• Monitor, collect, process, triage and distribute serious adverse and clinical event reports to sponsors, regulatory authorities, and project team
• Differentiate AEs, SAEs, endpoint events, UADEs, and SUSARs; categorize, code and adjudicate events
• Compile patient hospital course and follow-up in a narrative form for regulatory reports and DSMB/PMA deliverables
• Determine need for additional information for accurate coding and reporting of adverse events and coordinate with project teams
• Initiate follow-up actions to resolve issues and ensure case closure
• Generate queries for missing data and perform reconciliation of events across Clinical and Safety databases
• Run database queries to identify potential events or safety trends for accurate trial interpretation
• Provide and maintain clean, adjudicated endpoints or safety databases prior to analysis
• Coordinate with assigned Clinical Specialist for SAE processing or CEC adjudication
• Act as expert clinical consultant to project teams on adverse events and device failures
• Follow internal SOPs for task execution

Skills

Microsoft Office

Safety reporting

Clinical trials knowledge

Adverse events assessment

Education

Bachelor of Nursing (RN) or Medical Degree, or PharmD

BS in Pharmacy/Pharmacology or Life Sciences

Tools

InForm

RAVE Medidata

Mednet

EmpiricaTrace

ARGUS

Zelta

Job description

Under the guidance of the Sr. Director, Safety Services, or the Clinical Project Manager, the Clinical Specialist performs project startup activities and development of the Safety Management Plan(s) and/or Clinical Event Committee (CEC) Manual of Operations for all assigned studies according to applicable regulatory guidance documents.

Primary Duties and Responsibilities:

• Under the guidance of the Sr. Director, Safety Services or the Clinical Project Manager performs project startup activities and development of the Safety Management Plan(s) and/or Clinical Event Committee (CEC) Manual of Operations for all assigned studies according to applicable regulatory guidance documents.
• Performs event management for assigned trials; evaluate eCRF/CRFs for medical content, completeness and reportability. Monitor, collect, process, triage and distribute serious adverse and clinical event reports to sponsor companies, regulatory authorities (FDA and EMA), and the project team within specified timelines.
• Demonstrates good clinical assessment skills. Identifies and differentiates AEs, SAEs, endpoint events, UADEs, and SUSARs in classifying reportable events and identifying those requiring adjudication.
• Utilizes expert clinical knowledge to review CRFs to identify the reportable events and make decisions about categorizing, coding (CEC, MedDRA, WHODRUG) and adjudicating events.
• Succinctly compiles information regarding the patient’s hospital course and follow-up in a standardized narrative form for inclusion in CEC documents, Regulatory reports (MedWatch, CIOMS) and DSMB, PMA and other quality deliverables.
• Determines need for additional information for accurate coding and reporting of adverse events and collaborates with the Project Teams to facilitate receipt of required information.
• Demonstrates problem solving skills by initiating or performing follow-up actions, facilitate resolution of identified or potential issues by collaborating with appropriate personnel for resolution.
• Performs due diligence in obtaining follow-up information by generating queries as necessary to resolve missing data and follow up until resolution with case closure.
• Run database queries to identify potential events, potential safety trends or quality processing issues to generate clean data for accurate interpretation of trial design and statistical analysis.
• Provides and maintains clean, adjudicated endpoints or Safety databases prior to analysis of assigned trials.
• Perform reconciliation of all events (SAE and/or clinical endpoints) between the Clinical and Safety, or other supporting databases.
• Coordinate with the assigned Clinical Specialist for processing of SAEs or the adjudication of MACE and/or endpoint events that require CEC adjudication.
• Perform other safety-related tasks as necessary.
• Act as an expert clinical consultant to the Project Teams and colleagues for adverse events, device failures, and other clinical issues. Follow internal company Standard Operating Procedures for execution of tasks.

Requirements:

Educational Requirement:

Bachelor of Nursing (RN Preferred)/ Medical Degree, or PharmD, BS in Pharmacy/Pharmacology or Life Sciences (ex. Biology, Biochemistry, Chemistry, Biotechnology), Physician Assistant

Technical Skills and Experience:

• 3 years critical care nursing or equivalent clinical experience in cardiology or other areas depending on trial assignments required or
• 1-3 years of safety experience
• Proficient in Microsoft Office
• Knowledge and understanding of clinical trials, safety reporting regulatory guidelines e.g. ICH and GCP guidelines.
• Understanding and experience with MedDRA and WHODRUG coding Preferred
• Experience with Clinical Databases Preferred- InForm, RAVE Medidata, Mednet; EmpiricaTrace, ARGUS, Zelta preferred.
• Strong preference for experience with Data Monitoring Committee management and medical writing experience.