Senior Clinical Research Specialist

Senior Clinical Research Specialist

JOB SUMMARY

Under general direction, this Senior 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, this position:

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

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

milestones;

• Oversees/executes 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);

• Contributes towards 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;

• Manages/oversees ordering, tracking, and accountability of investigational devices and trial

materials;

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

personnel;

• Interfaces, collaborates and oversees Clinical Research Associates (CRAs);

• Oversees and supports the development and execution of Investigator agreements and trial

payments;

• Is responsible for 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 contribute to the development and delivery of appropriate global evidence generation

strategies (EGS) and evidence dissemination strategies (EDS) within the assigned projects;

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

trial sites;

• Contributes to the critical assessment of the literature and to the interpretations and

disseminations of all evidence generated;

Contributes to delivery of assigned clinical projects, through effective partnership with the study

core team leading to delivery of clinical project commitments (deliver on time, within budget and

in compliance with regulations and SOPs);

• May assist with the development of e Post-Market Clinical Follow-up (PMCF) Plans and PMCF

Evaluation Reports (ER) within the defined timelines and review/update at planned intervals;

May assist with maintaining the overview to assure (study) commitments are timely and properly

met by coordination of specific documentation and contribution to cross-functional review of

associated documents where relevant;

• Supports project/study budget activities;

• Mentors team members;

• 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, dependent on project complexity. Independent

decision-making for simple and more advanced 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 4 years, MS with at least 3 years, PhD with at least 2 years of relevant

experience preferred.

• Previous experience in clinical research or equivalent is required.

• 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 highly preferred.

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 delivery of clinical projects within clinical/ surgical research

setting, on time, within budget and in compliance to SOPs and regulations;

• Good presentation and technical writing skills;

• Good written and oral English communication skills;

Leadership Competencies:

Ability to lead small study teams to deliver critical milestones, as may be assigned.

Leadership required in alignment with J&J Leadership Imperatives:

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

• Shape - Make recommendations for and 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.