Clinical Research Specialist

Description :

Clinical Research Specialist

JOB SUMMARY

Under general direction, this Clinical Research Specialist will be responsible for supporting one or

several clinical trials within the Clinical R&D Department while fostering strong, productive relationships

with colleagues across the organization.

DUTIES & RESPONSIBILITIES

In accordance with all applicable federal, state and local laws / regulations, procedures and guidelines, this position :

• Serves as a Clinical Research Specialist within the Clinical R&D Department to support execution

of company sponsored clinical trials, ensuring compliance with timelines and study milestones,

for MedTech Electrophysiology under supervision;

allocated countries, in accordance with the ICH-GCP, applicable legislation and Company

Standard Operating Procedures;

CRF, monitoring plan, study manual, investigator brochure, annual reports);

posting of results and support publications as needed;

trial materials;

personnel;

and trial payments;

monitoring visits or close out visits based on study need;

sites;

by key stakeholders;

requires guidance for complex situations.

level;

practices as applicable;

Company guidelines related to Health, Safety and Environmental practices and that all resources

needed to do so are available and in good condition, if applicable;

Company regulations, policies, and procedures

Performs other duties assigned as needed;

o Coordination of all safety-related activities of clinical trials;

o Strategic planning and coordination of all new safety initiatives;

o Development of clinical study safety management plan (SMP) and study-specific safety

flow in accordance with internal procedures and applicable safety regulations for clinical

research;

o Cooperation with the necessary stakeholders (clinical study team, medical, clinical sites,

regulatory, data management) on safety activities related to clinical studies and guarantee

adherence to the SMP;

o Works with data management to ensure timely database notifications to relevant parties;

o Coordinates the collection of required information on safety events with the clinical study

team;

o Cooperates with cross-functional teams (Research & Development, Complaint Handling,

Quality / Regulatory, Medical Affairs, Medical Safety) to ensure safety and complaint

reporting compliance for each clinical study;

o Coordinates review of clinical safety data with the clinical study team, Medical Affairs or

Medical Safety team;

o Ownership of the study safety inbox and coordination of timely reporting of study adverse

events to competent authorities and ethics committees;

o Create safety reports for reporting to internal stakeholders, investigators, ethics

committees and authorities;

o Assists in scheduling and coordination of safety adjudication process;

o Coordinates safety board meetings and acts as point of contact for any questions;

o Ensures all safety reports are directed to the appropriate staff.

EXPERIENCE AND EDUCATION

Education

Biological Science required.

Experience

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS / LICENSES and AFFILIATIONS

Functional and Technical Competencies :

clinical trial regulations;

time, and in compliance to SOPs and regulations;

Leadership Competencies :

Leadership required in alignment with J&J Leadership Imperatives :

transparent and constructive conversations.

and in compliance to SOPs and regulations.