Clinical Research Specialist II, Genetics

CMC_Operations; Cleveland (OH); Presencial; USD 65.000 - 90.000; Jornada completa

Descripción de la vacante

University Hospitals in Cleveland, OH seeks a Clinical Research Specialist II, Genetics to coordinate complex trials under PI supervision. You will manage regulatory filings, consent processes, and CRFs while upholding GCP standards and sponsor guidelines. You’ll support SOPs, grants, and manuscript prep and mentor junior staff.

The role requires a Bachelor's degree and 2+ years of clinical research experience, with strong communication and documentation skills. Travel is possible as needed.

Formación

• Bachelor's degree is required in a related field.
• 2+ years of clinical research experience required.
• Experience working in a team environment is required.
• Knowledge of GCP and FDA guidelines is required.
• Ability to train and mentor junior staff.
• Strong attention to detail and documentation skills.

Responsabilidades

• Coordinate regulatory submissions and maintain regulatory files.
• Screen participants for eligibility, obtain informed consent, educate participants and complete CRFs.
• Maintain in-depth knowledge of protocol requirements and GCP guidelines.
• Document and assimilate participant and study records per SOPs and sponsor guidelines.
• Assist with SOPs, grants and protocol development; prepare manuscripts and presentations.
• Establish and maintain communications with investigators, sponsors and internal teams.
• Mentor junior staff in the clinical research process.
• Perform other related duties as assigned or required.

Conocimientos

GCP guidelines

FDA guidelines

EDC software

Medical terminology

Mentoring

Communication

Time management

Detail oriented

Independent work

Customer service

MS Office

Educación

Bachelor's Degree

Herramientas

EDC software

Microsoft Excel

Word

PowerPoint

Outlook

Descripción del empleo

Job Description - Clinical Research Specialist II, Genetics (260008PX)

Clinical Research Specialist II, Genetics - ( 260008PX )

A Brief Overview

Works with the Principal Investigator to coordinate all aspects of implementation of assigned multiple and/or complex clinical research trials.

What You Will Do

• Responsible for submission of related documents to the appropriate regulatory review committees and maintenance of regulatory files. (10%; Competency 1, 2)
• Performs all activities related to clinical research studies including but not limited to: screening participants for eligibility and recruitment, obtains informed consent, educates participants regarding study requirements and completes case report forms (CRF). (20%; Competency 1, 2)
• Responsible for in-depth knowledge of protocol requirements and Good Clinical Practice (GCP) guidelines. (10%; Competency 1, 2)
• Documents, records and assimilates accurate participant records and study records to ensure documentation compliance with sponsor guidelines, standard operating procedures (SOP) and internal and external regulatory agencies. (20%; Competency 1, 2)
• Assists with SOP, grant and protocol development and active participant in preparation of manuscripts and presentations for scientific meetings. (10%; Competency 2,3)
• Establish and maintain communications with Investigator, Sponsor and internal constituents. (10%; Competency 1, 2)
• Mentorship of the clinical research process to the junior clinical research staff. (10%; Competency 3)
• Performs other related duties as assigned or required. (10%; Competency 1, 2, 3)

Additional Responsibilities

• Performs other duties as assigned.
• Complies with all policies and standards.
• For specific duties and responsibilities, refer to documentation provided by the department during orientation.
• Must abide by all requirements to safely and securely maintain Protected Health Information (PHI) for our patients. Annual training, the UH Code of Conduct and UH policies and procedures are in place to address appropriate use of PHI in the workplace.

Education

• Bachelor's Degree (Required)

Work Experience

• 2+ years clinical research experience (Required) and
• Experience in a team setting (Required)

Knowledge, Skills, & Abilities

• Ability to prioritize the work of multiple projects. (Required proficiency)
• Knowledge of GCP and FDA guidelines. (Required proficiency)
• Knowledge of Electronic Data Capture Programs. (Required proficiency)
• Medical & Research Terminology. (Required proficiency)
• DOT/IATA Training (Preferred proficiency)
• Ability to train and mentor junior staff. (Required proficiency)
• Detail-oriented person with the ability to collect, compile, and analyze information. (Required proficiency)
• Ability to understand and communicate research protocol requirements to others. Able to work independently on multiple tasks and manage time effectively. (Required proficiency)
• Demonstrates customer service excellence with internal and external customers (Required proficiency)
• Excellent verbal, written, interpersonal and communication skills. (Required proficiency)
• Computer skills (Outlook, Excel, PowerPoint, Word). (Required proficiency)

Licenses and Certifications

• Certification in Human Subjects Protection (CITI) (Required within 30 Days)
• Society of Clinical Research Associates (SoCRA) (Preferred) or
• ACRP Certified Professional (ACRP-CP) (Preferred)

Physical Demands

• Standing Frequently
• Walking Frequently
• Sitting Rarely
• Lifting Frequently up to 50 lbs
• Carrying Frequently up to 50 lbs
• Pushing Frequently up to 50 lbs
• Pulling Frequently up to 50 lbs
• Climbing Occasionally up to 50 lbs
• Balancing Occasionally
• Stooping Frequently
• Kneeling Frequently
• Crouching Frequently
• Crawling Occasionally
• Reaching Frequently
• Handling Frequently
• Grasping Frequently
• Feeling Constantly
• Talking Constantly
• Hearing Constantly
• Repetitive Motions Constantly
• Eye/Hand/Foot Coordination Constantly

Travel Requirements

• 10% Travel may be required