IQVIA Clinical Research Associate Training Program, Dermatology, Oncology, MD&D (Nationwide) - Novella Clinical in Seattle, Washington

Description:

Novella Clinical is currently taking applications for our CRA Training Program.

Candidates must meet the following requirements:

  • 2 or more years of experience coordinating clinical trials in the following areas: Oncology , Dermatology and/or Medical Device experience.

  • Nursing or University Degree (US Bachelor Level or equivalent) in one of the life sciences and ideally with ideally two (2) years of clinical trial experience

  • Effective time management skills.

PURPOSE / BASIC FUNCTIONS:

Engages in company training program to gain knowledge and skills required to independently conduct clinical monitoring visits in accordance with study protocol, standard operating procedures, good clinical practices, and applicable regulatory requirements. Will engage in extensive training with enhanced oversight as well as dedicated mentoring from senior Clinical Research Associates (CRAs) and Managers.

TYPICAL RESPONSIBILITIES MAY INCLUDE:

  • Complete appropriate therapeutic, protocol, clinical research, SOP and systems training to perform job duties.

  • Gain experience in study procedures by working with experienced clinical monitoring staff.

  • Under close supervision:

  • Perform site selection (if applicable), initiation, monitoring and close out visits in accordance with contracted scope of work and good clinical practices.

  • If applicable, learn key facets for successful development of project subject recruitment plan on a per site basis. Suggest ideas to CRA and/or CTM for improving site recruitment plan in line with project needs to enhance predictability. Assist CRA and/or CTM in tracking subject site recruitment progress.

  • Administer protocol and related study training to assigned sites and establishes regular lines of communication with sites to manage ongoing project expectations and issues. Convey features and opportunities of study to site.

  • Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.

  • Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.

  • Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, Case Report Form (CRF) completion and submission, and data query generation and resolution. Under close supervision may support start-up phase.

  • Collaborate and liaise with study team members for project execution support as appropriate.

KNOWLEDGE, SKILLS AND ABILITIES:

  • Knowledge of clinical research process and medical terminology.

  • Ideally two (2) years of experience coordinating clinical trials.

  • Ideally two (2) years of oncology, biopharma, dermatology and/or medical device experience.

  • Good organizational, problem-solving and interpersonal skills.

  • Effective time management skills.

  • Ability to reason independently and recommend specific solutions in clinical settings.

  • Good written and verbal communication skills including good command of English language.

  • Ability to collaborate and communicate with a variety of colleagues and customers.

  • Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer

  • Able to qualify for a major credit card. (US Only)

  • Valid driver’s license; ability to rent automobile.

CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:

  • Ability to travel domestically and/or internationally as required

  • Very limited physical effort required to perform normal job duties

  • Extensive use of telephone and face-to-face communication requiring accurate perception of speech

  • Extensive use of keyboard requiring repetitive motion of fingers

  • Regular sitting for extended periods of time

MINIMUM RECRUITMENT STANDARDS:

  • Nursing or University Degree (US Bachelor Level or equivalent) in one of the life sciences and ideally with ideally two (2) years of clinical trial experience

  • Computer literacy and knowledge of electronic data capture preferred.

  • Must possess good written and verbal communication (proficient in English), interpersonal, and organizational skills.

  • Must be able to travel approximately 65%-85%, domestic or international, as required.

CLASSIFICATION:

US: This position is classified as non-exempt under the Fair Labor Standards Act; employees are eligible for overtime compensation.

Qualifications:

EEO Minorities/Females/Protected Veterans/Disabled

Primary Location:

USA-North Carolina-Research Triangle Park

Other Location(s):

USA-California-Berkley, USA-Nebraska-Lincoln, USA-Wisconsin-Milwaukee, USA-Nebraska-Omaha, USA-Kentucky-Richmond, USA-Kentucky-Lexington, USA-West Virginia-Charleston, USA-Virginia-Northern Virginia, USA-California-West Covina, USA-Arizona-Tucson, USA-Wisconsin-Green Bay, USA-Maine-Portland, USA-Arizona-Phoenix, USA-Florida-Clearwater, USA-Illinois-Springfield, USA-Arizona-Flagstaff, USA-Illinois-Chicago, USA-Tennessee-Memphis, USA-Florida-Jacksonville, USA-California-Santa Cruz, USA-Tennessee-Knoxville, USA-West Virginia-Wheeling, USA-Massachusetts-Boston, USA-Massachusetts-Burlington, USA-Kentucky-Bowling Green, USA-Florida-Miami, USA-Florida-Orlando, USA-California-San Diego, USA-Illinois-Peoria, USA-Virginia-Fredericksburg, USA-California-Long Beach, USA-California-Pasadena, USA-Oregon-Portland, USA-Virginia-Charlottesville, USA-Washington-Seattle, USA-Maine-Bangor, USA-Illinois-Rockford, USA-Massachusetts-Salem, USA-California-Napa