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Thermo Fisher Scientific · 1 day ago

Clinical Research Coordinator III - RN

Frederick, MD

Part-time

Onsite

Senior Level

$38.46/hr - $44.23/hr

5+ years exp

Thermo Fisher Scientific is a global leader in serving science, and they are seeking a Clinical Research Coordinator III (Registered Nurse) to support their government customer in Silver Spring, Maryland. The role involves organizing and prioritizing activities related to clinical research studies, ensuring compliance with regulations, and overseeing data collection and analysis.

Research

No H1B

U.S. Citizen Only

Responsibilities

Organizes and prioritizes all activities associated with conducting phase 1, 2, and 3 clinical and operational research studies within a military clinic setting

Reviews and understands research protocols, ensuring applicable regulations and guidelines are followed

Organizes research information for clinical projects

Selects and observes subjects and assists with data analysis and reporting

Oversees experiment scheduling and collection of data

Participates in source document and study document design, writing SSP, materials planning, visit schedule creation, etc

Enters required data routinely on CRFs and audit records for accuracy, resolve discrepancies, and correct as necessary

Maintains study/test article or investigational product accountability and administration

Monitors study data collection procedures to ensure uniformly high levels of compliance with GCP, GLP, FDA and other government- or locally required guidance

Relies on experience and judgment to plan and accomplish goals. Works under general supervision and performs a variety of tasks

Qualification

Registered Nurse LicenseClinical Research CoordinationFDA-regulated TrialsClinical Trial Management SystemsBasic Life Support CertificationPrioritization SkillsEffective Working RelationshipsMaintenance of CertificationAdvanced Cardiac Life SupportCertification in Clinical ResearchCommission for Case Manager CertificationCommunication SkillsOrganization SkillsTeamwork Skills

Required

Must be a U.S. citizen

Must be able to pass a comprehensive background check, which includes a drug screening and a physical

Required to be a Registered Nurse licensed to practice in the state of Maryland

Required to be a Registered Nurse licensed to practice in the state of Maryland, who is skilled and qualified in nursing procedures to include, but not limited to the administration of experimental vaccines and other parenteral therapeutics as per specific protocol guidance in accordance with the 21 Code of Federal Regulation (CFR) 11, 50, 54, 56, 312, and 314

Basic Life Support (BLS -CPR/AED) certification

Five (5) years of experience in clinical research coordination, with expertise in FDA-regulated trials

Experience utilizing clinical trial management systems and databases (e.g., REDcap and Inform)

Must be able to work both independently and in a team setting following a brief period of specific technical training

Must have excellent communication, organization, and prioritization skills

Ability to establish and maintain effective working relationships with coworkers, managers and customers

Maintenance of Certification in Clinical Research Coordination by Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SoCRA)

Preferred

Advanced Cardiac Life Support (ACLS) certification encouraged

Certification in clinical research (e.g., CCRP or CCRA) is preferred

Commission for Case Manager Certification (CCMC) certification preferred

Benefits

A choice of national medical and dental plans, and a national vision plan, including health incentive programs

Employee assistance and family support programs, including commuter benefits and tuition reimbursement

At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy

Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount