Clinical Research Specialist I Jobs

Review education and training experience with line manager and complete identified training needs within designated time period.

*Basic knowledge of site management and clinical monitoring for clinical research studies

Maintain job knowledge and skills through independent self-study.

OR EQUIVALENT COMBINATION OF EDUCATION AND EXPERIENCE

None required beyond that described above. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE

Perform assessment of site personnel and facilities for study conduct through feasibility and site telephone qualification

Computer skills including at least intermediate level experience with Excel and other Microsoft Office Software

Bachelors degree or equivalent work experience required

2-4 years experience in clinical research preferred

2-4 years non-profit, research, or healthcare experience desired

Knowledge of CFR, GCP and ICH guidelines

Promote safety and confidentiality of research participants at all times

Be organized, show attention to detail, and have exceptional follow-through abilities.

Have clinical decision-making and assessment skills, enjoy face-to-face interactions with patients and study participants, and interfacing with investigators and clinicians.

Work Arrangement (final schedule to be determined by the department/hiring manager): Onsite

To collect and record preliminary data for clinical research programs.

To recruit and perform follow-up with research participants as protocols outline.

To schedule visits according to research protocols.

The Clinical Research Coodinator I conducts and manages clinical trials in accordance with the study protocol,GCP, and Velocity’s SOPs.

Conduct and manage clinical trials in accordance with the study protocol, GCP, ICH Guidelines and Velocity’s SOPs

Implement research and administrative strategies to successfully manage assigned protocols.

Create, collect, and submit regulatory documents to Sponsors and IRBs as required per protocol, GCP/ICH regulations, and IRB requirements.

Bachelor’s degree with 1 year of relevant experience in the life science industry OR

Associate’s degree with 2 years of relevant experience in the life science industry OR

Participates in required training and education programs.

1-year Clinical Research Related Experience

Join our team and use your skills with an organization known nationally for excellence in research!

Works with a Clinical Research Coordinator, Research Program Administrator or Research Nurse to coordinate/implement study.

Evaluates and abstracts clinical research data from source documents.

Ensures compliance with protocol and overall clinical research objectives.

Bachelor's Degree in related discipline, or equivalent combination of education and experience.

Prior experience in research or a related field/setting.

Confirmed proficiency in a second language via successful completion of a language assessment may be required for certain departments.

Min to Max Hourly Salary$26. 81 - $40.21 /hr

Min to Max Annual Salary$55,764.80 - $83,636.80 /yr

The union pay ranges can be found on the Seattle Children's website here: -

Explains and performs non-GCP related study management activities.

Competitive salary: Pay based experience

Two years patient care experience or one year clinical research experience with a bachelor's degree

Masks are provided to patients entering our buildings, and offered free to visitors

What We Have to Offer

See Full List of Benefits Here: 2022 INOVA BENEFITS GUIDE

• Demonstrated experience in establishing and maintaining effective relationships with management, peers and subordinates and customers.

5) What are the top 5 skills/requirements this person is required have?

• Manage and prioritize work load, multi-task and manage a diverse mix of issues, responsibilities and challenges.

a. Required Skill 1: Organized and great attention to detail

b. Required Skill 2: Strong communication skills and intrapersonal skills

c. Required Skill 3: Takes initiative and works well alone and also within a team

Good organizational and time management skills

Or an equivalent combination of education and experience to successfully perform the key responsibilities of the job

To manage sites to ensure subjects are complying with protocol requirements, study visits, and timelines

Perform other duties as assigned by management

To facilitate translation and back translation of all necessary documents, as appropriate for local country requirements, as needed regionally

Good communication skills, oral and written

Knowledge of clinical research study processes, protocol management, and regulatory guidelines.

Proficiency in medical terminology and computer skills.

Strong attention to detail and excellent written and oral communication skills.

Ability to manage multiple deadlines and prioritize tasks effectively.

Minimum three years of experience in conducting clinical research studies or verifying clinical data.

Knowledge across multiple therapeutic areas, including blood and marrow transplant.

Experience with Clinical Trials Management System (i.e., OnCore, Velos, etc.)

Organize and manage time and tasks independently

2 years of health care operations experience preferably in clinical research

Demonstrated skills in critical thinking and problem solving

Strong written and verbal communication skills

2 years of clinical research experience

Your responsibilities as the Research Specialist will include:

To learn more, please visit: https://www.hr.upenn.edu/PennHR/benefits-pay

Cell processing and tissue culture. Isolate and process fibroblasts from murine skin samples. Maintain cell cultures for differentiation assays.

Maintain mouse colonies (set up breeding, monitor health and maintain records).

Perform in vivo wound healing or tumor studies in mice.

Perform tissue fixation, embedding and sectioning for histology.

Assists with coordination and management of clinical trials including communication with Sponsors.

Under direct supervision of the Principle Investigator(s), obtains informed consent and educates participants regarding study requirements.

0-2 years of experience in a hospital or academic (research) environment preferred.

Excellent written and oral communication skills

Collects and records study data; inputs all information into database.

Secures, delivers and ships clinical specimens as required by the protocol.

Required Knowledge, Skills And Abilities

Must maintain a current status on Natera training requirements.

Employee must pass post offer criminal background check.

Experience in insurance collections or medical billing preferred.

Experience with Microsoft Excel, Google mail and Google Documents

Assist with data collection for internal projects/ product development and operations related to reimbursement.

Excellent organizational, time management, and problem-solving skills.

Support and comply with the company’s Quality Management System policies and procedures.

Basic proficiency of ICH GCP and monitoring practices with a track record for ensuring quality data and performing outstanding site management.

Supports the Clinical Study Manager to develop study-specific training materials.

Conducts thorough site qualifications visits. Ensures all required information concerning site/staff qualifications is clearly documented and communicated to project teams.

Works with clinical study manager to manage vendors (ie. Central Laboratory, CRF printers, CROs, etc).

Obtain informed consent and educate participants regarding study requirements.

1-2 years clinical research experience

Pristine attention to detail and ability to manage time appropriately, able to multitask in a fast-paced environment

Collect and record study data and input all information into a database.

Assist in IRB/GCO applications as needed.

Collect, process, deliver and ship clinical specimens as required by the protocol.

Obtains informed consent under minimal supervision of the investigator(s) and educates participants regarding study requirements.

1-2 years of research experience

Collects and records study data. Inputs all information into database.

Assists in preparing grant applications, IRB/GCO for submission and filings.

Secures, delivers and ships clinical specimens as required by the protocol.

Bachelors or Masters degree in Science or closely related field.

Experience with executing molecular biology protocols (ideally with a focus on next generation sequencing techniques)

Drosophila maintenance, crossing, and screening

Molecular biology including DNA/RNA preparation, PCR, qRT-PCR, next generation sequencing.

Lab organization, maintenance, and purchasing

Bachelor’s degree in biology or related field

Capacity to work both independently and collaboratively

Obtains informed consent under minimal supervision of the investigator(s) and educates participants regarding study requirements.

1-2 years of research experience

Collects and records study data. Inputs all information into database.

Assists in preparing grant applications, IRB/GCO for submission and filings.

Secures, delivers and ships clinical specimens as required by the protocol.

Bachelors or Masters degree in Science or closely related field.

Participates in required training and education programs.

Understanding of general clinical research objectives. One (1) year of clinical research experience is preferred.

Ability to interpret and apply knowledge of State, Federal and Agency standards to comply with regulations.

Must possess computer skills, including Word and Excel, and the ability to use standard office equipment is required.

Assists with clinical trial budgets and patient research billing.

Completes Case Report Forms (CRFs).