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;

• Participates in the feasibility, selection, set up, conduct and closure of a clinical trial within the

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

Standard Operating Procedures;

• May serve as the primary contact for clinical trial sites (e.g. site management);

• Assists in the development of clinical trial documents (e.g. study protocol, informed consents,

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

• Supports applicable trial registration (e.g. from study initiation through

posting of results and support publications as needed;

• Coordinates and executes ordering, tracking, and accountability of investigational devices and

trial materials;

• Interfaces and collaborates with site personnel, IRBs/ECs, contractors/vendors, and company

personnel;

• Interfaces and collaborates with Clinical Research Associates (CRAs);

• Assists in overseeing and supports the development and execution of Investigator agreements

and trial payments;

• Assists in clinical data review to prepare data for statistical analyses and publications;

• May perform monitoring activities including site qualification visits, site initiation visits, interim

monitoring visits or close out visits based on study need;

• May provide on-site procedural protocol compliance and data collection support to the clinical trial

sites;

• Assists in tracking assigned project budgets;

• Function as a reliable, trusted resource of accurate, up-to-date project knowledge as requested

by key stakeholders;

• Should develop a strong understanding of the pipeline, product portfolio and business needs;

• Generally manages work with supervision. Independent decision-making for simple situations but

requires guidance for complex situations.

• Responsible for communicating business related issues or opportunities to next management

level;

• Responsible for following all Company guidelines related to Health, Safety and Environmental

practices as applicable;

• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all

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;

• Responsible for ensuring personal and Company compliance with all Federal, State, local and

Company regulations, policies, and procedures

Performs other duties assigned as needed;

• May act as Clinical Safety Coordinator:

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

• Minimum of a Bachelor’s Degree preferably in Life Science, Physical Science, Nursing, or

Biological Science required.

Experience

• BS with at least 2 years, MS and PhD with at least 1 year of relevant experience preferred.

• Previous experience in clinical research or equivalent is desired.

• Relevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV,…).

• Clinical/medical background is a plus.

• Medical device experience is a plus.

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

Functional and Technical Competencies:

• Good understanding of clinical research science and processes, clinical trends, and global

clinical trial regulations;

• Proven track record in supporting clinical projects within clinical/ surgical research setting, on

time, and in compliance to SOPs and regulations;

• Presentation and technical writing skills;

• Written and oral English communication skills.

Leadership Competencies:

Leadership required in alignment with J&J Leadership Imperatives:

• Connect - Develop collaborative relationships with key internal and external stakeholders.

• Shape - Actively participate in departmental process improvement activities.

• Lead - Take ownership in critical scientific thinking and development of self and engage in

transparent and constructive conversations.

• Deliver - Strive to ensure all deliverables on allocated studies are met on time, within budget

and in compliance to SOPs and regulations.