Clinical Research Specialist

The Jackson Laboratory; Farmington (CT); On-site; USD 70,000 - 101,000; Full time

Job summary

The Jackson Laboratory seeks a Clinical Research Specialist to support investigators and clinical collaborators in designing and implementing clinical studies in compliance with GCP and regulations. The role involves proposal development, site identification, IRB submissions, and SOP maintenance, under the DCTRS.

Ideal candidates hold a master’s in health sciences or related fields and have at least three years of patient-facing clinical research experience within academic or clinical settings.

Qualifications

• Master’s degree in health sciences or a relevant scientific area (e.g. epidemiology, clinical research administration, public health, biology).
• Experience in patient-facing clinical research (study coordination) in an academic or clinical setting.
• Knowledge of clinical study design, IRB regulations and informed consent processes.

Responsibilities

• Support development of clinical study protocols, grant proposals and IRB submissions.
• Identify and qualify clinical sites; prepare initial IRB submission materials and recruitment plans.
• Contribute to SOPs and educational programs on compliance with regulations and policies.
• Collaborate with investigators and staff to move projects forward through IRB processes.

Skills

Excellent written and oral comms

Strong organizational skills

Interpersonal skills

Multitasking and prioritization

Education

Master’s Degree in health sciences or relevant field

Job description

Job SummaryUnder the supervision of the Director, Clinical & Translational Research Support (DCTRS), the Clinical Research Specialist (CRS) supports investigators at The Jackson Laboratory and their clinical collaborators by contributing clinical site and regulatory expertise to grant proposal development and clinical protocol design, development and implementation.This role facilitates expansion of the JAX clinical research portfolio and ensures that clinical studies are designed and conducted per established policies, procedures, regulations, and good clinical practices (GCP).Key ResponsibilitiesProvide support to JAX faculty and collaborators in developing clinical research proposals for external and internal funding by contributing to study design, human subject protection components, and development of clinical study protocols for funded grants Participate in clinical site management activities and provide site support through identification and qualification of clinical sites, preparation of initial IRB submission materials and recruitment plans, providing ongoing problem solving and support to clinical sites. Develop and maintain JAX clinical research Standard Operating Procedures Contribute clinical research operations expertise to development of project components Collaborate with DCTRS and JAX IRB in developing and delivering educational programs to investigators and key study personnel on compliance with federal regulations and JAX policies & procedures Facilitate collaborative research between JAX investigators and clinical site investigators and staff by taking the lead in clinical protocol and supporting document development and moving the project forward through IRB submissionEducation and Minimum RequirementsMaster’s Degree in health sciences or relevant scientific area (e.g. epidemiology, clinical research administration, public health, biology)Minimum of three years of experience in patient facing clinical research (study coordination) in an academic or other clinical settingKnowledge, Skills & AbilitiesKnowledge and experience in clinical study design, statistical analysis, protocol development, informed consent process and regulation, CRF development, IRB regulations and requirementsExcellent written and oral communication skills and ability to work with multi-disciplinary collaboratorsAbility to handle multiple activities simultaneously and to effectively prioritize tasks and responsibilitiesStrong organizational and problem-solving skillsStrong interpersonal skillsStrong commitment to customer service.Pay Range: $69,711 - $101,081, pay is determined by years of experienceAbout JAX:The Jackson Laboratory is an independent, nonprofit biomedical research institution with a National Cancer Institute-designated Cancer Center and nearly 3,000 employees in locations across the United States (Maine, Connecticut, California, New York, Florida), Japan and China. Its mission is to discover precise genomic solutions for disease and empower the global biomedical community in the shared quest to improve human health.Founded in 1929, JAX applies over nine decades of expertise in genetics to increase understanding of human disease, advancing treatments and cures for cancer, neurological and immune disorders, diabetes, aging and heart disease. It models and interprets genomic complexity, integrates basic research with clinical application, educates current and future scientists, and provides critical data, tools and services to the global biomedical community. For more information, please visit www.jax.org.EEO Statement:The Jackson Laboratory provides equal employment opportunities to all employees and applicants for employment in all job classifications without regard to race, color, religion, age, mental disability, physical disability, medical condition, gender, sexual orientation, genetic information, ancestry, marital status, national origin, veteran status, and other classifications protected by applicable state and local non-discrimination laws.