Clinical Research Associate Job at Novotech, Boulder, CO

MnZ0M012eStMNlloeXc3Q3RFb3diL0NuV2c9PQ==
  • Novotech
  • Boulder, CO

Job Description

About the Role

The Clinical Research Associate (CRA) is primarily responsible for ensuring the rights and wellbeing of trial participants are protected and the reported trial data are accurate, complete, and verifiable from the source documents. The CRA is the primary contact between the Investigational Sites, Novotech, and Sponsor. Key responsibility of a CRA is as a site relationship manager ensuring that clinical trials are conducted in accordance with ICH GCP guidelines, local and global regulatory requirements, and Novotech/Client SOPs.


Responsibilities

  • CRAs primary responsibility is to build relationships with Principal Investigators, study co-ordinators, pharmacists, and all relevant site trial personnel to ensure the efficient, expedited, and smooth management of clinical trials.
  • Foster internal and external customer relationships to ensure focus on efficient, timely and productive project delivery as per study requirements and timelines.
  • In collaboration with the In-house Clinical Research Associate (IHCRA) and Regulatory Start-Up Associate (RSA), prepare site essential documents, and support the ethics and regulatory submission and approval processes as needed.
  • In collaboration with Regulatory Start-up (RSU) Team, understand the requirements of applicable local and international regulatory requirements as relevant to specific clinical trials.
  • Ensure recruitment of participants as per the site target. Drive site recruitment and engagement initiatives and prepare site-specific recruitment plan(s) and update as required.
  • Monitoring of investigational sites as per ICH GCP §5.18 (Monitoring) and the Clinical Monitoring Plan (CMP) for each study. This includes all monitoring visit types across all phases of a clinical trial including Site Selection, Site Initiation, Site Monitoring and Site Close Out, unblinded pharmacy visits, and co-monitoring visits. Visits can be conducted either onsite or remote as per CMP.
  • Ensure the rights & wellbeing of trial participants are protected, including consent form checks, patient eligibility confirmation, protocol compliance, investigational drug compliance, and review of Adverse Events/SAEs. Ensure safety issues are reported to the sponsor promptly.
  • Verify trial data are accurate and complete, ensure CRF data and queries are completed and resolved as per the study timelines documented in the Clinical Monitoring Plan.
  • Ensure all study drug is appropriately stored, dispensed, accounted for, and reconciled as per the Clinical Monitoring Plan and the Protocol.

Experience and Qualifications

  • Graduate in a clinical or life sciences-related field. Relevant experience/qualifications in allied professions may also be considered.
  • Must have good time management skills, attention to detail, be able to work well in a team, and be computer literate.
  • Preferably experience of working in the research, pharmaceutical industry or a related field per job level as follows:
  • At least 2-3 years of Clinical Research Associate experience in the Clinical industry.
  • Excellent interpersonal and team skills with a genuine commitment to contributing to the development of innovative treatments

Salary Band - Clinical Research Associate - $80,000USD-$125,000USD - Salary offered will be based on candidates experience level.


Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect.


Our team members are passionate about what we do, but we understand work is only one of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs.


We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.


We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to talking to you about working at Novotech.

Job Tags

Local area, Remote work, Flexible hours,

Similar Jobs

TLC Nursing

Travel Registered Nurse Endoscopy Job Job at TLC Nursing

Step into a pivotal role as a Registered Nurse specializing in Endoscopy in Saint Louis, Missouri, where your clinical expertise, compassionate patient...  ...by a comprehensive network with 24/7 assistance for travelers, ensuring you have immediate access to onboarding, housing... 

Cleft of the Rock, Inc.

Junior Sales Representative Job at Cleft of the Rock, Inc.

Junior Sales Representative About Us At Cleft of the Rock, we believe business is about more than numbers it's about people. Our mission...  ...with commission-based pay (average $65,000$85,000 for entry-level). Optional base draw during your first 6 weeks to support your... 

EpiCenter So Cal

AT&T Wireless Sales Agent Job at EpiCenter So Cal

 ...the latest technology and sales? At our company, we represent one of the most recognized names in the telecommunications industry, AT&T, and were expanding our sales team! The ideal candidate for our AT&T Wireless Sales Agent position is not only a strong communicator... 

Kandu Inc.

Salesforce Administrator Job at Kandu Inc.

 ...grounded in clinical evidence and informed by the lived experiences of patients and their families. We are seeking a remote Salesforce Administrator whos eager to learn, grow, and help streamline how our teams use Salesforce to deliver outstanding service and... 

Biggers Mazda

Part-time Cashier / Receptionist Job at Biggers Mazda

DescriptionIdeal job for local college students! Biggers Auto Group is currently looking for a part-time cashier/ receptionist to join...  ...to detail* Professional appearance* Ability to multitask and work independently* Be willing to submit to a pre-employment...