Clinical Research Associate - Colorado/Kansas Region
Chadds Ford, PA
Our client is looking for a highly qualified and skilled professional for the role of Clinical Research Associate in the Colorado/Kansas Region. The primary responsibilities of this position is to conduct routine site monitoring visits and participate in site selection, site initiation and study closure activities. This person will ensure that the clinical trial is being conducted according to the approved protocol, amendments and in compliance with Good Clinical Practice (GCP), Company SOPs, and all applicable regulatory requirements.
- Responsible for evaluation, initiation, monitoring, close-out and other tasks associated with the management of clinical sites
- Ensure the conduct of all clinical studies is in accordance with Good Clinical Practices, International Harmonization Guideline, and appropriate Standard Operating Procedures (SOP)
- Serve as primary contact for CROs/vendors, Investigators and study coordinators for study related questions
- In conjunction with study team, support feasibility and site selection process for clinical studies
- Assist and support development and review of clinical protocols, informed consent forms, or other study-related clinical documents (e.g. Case Report Forms, Source Documents, Monitoring Plan, Data Management Plan, Project Management Plan, etc.)
- Manage patient recruitment strategies to increase patient randomization into the trial (eg investigator and research nurse meetings, update newsletters, advertising, letters to GPs)
- Review all AE/SAEs and ensure appropriate documentation is in place and any other safety issues are addressed and communicated
- Assist and support data validation and data cleaning procedures to ensure timelines are met
- Order and coordinate study supplies for clinical studies
- Develop and maintain tracking tools to support management of clinical studies
- Plan and participate in Investigator meetings and CRA trainings
- May accompany CRO/CRA’s to co-monitor activities at clinical study sites to assure adherence to Good Clinical Practices (GCP’s), SOP’s and study protocols
- The role will also provide guidance, clinical trial management and direction to other junior Clinical Research Associates
- Minimum of 5+ years of experience in the pharmaceutical / biotechnology industry monitoring as a Clinical Research Associate from study start-up to database lock
- Strong Oncology monitoring experience in phase 1-3 pharmaceutical/ biotechnology clinical trials
- Possess good understanding of ICH guidelines, Good Clinical Practices (GCP), PhRMA code, FDA CFR, clinical research ethics, HIPAA and patient privacy laws, and other relevant, local regulatory requirements
- Good knowledge of concepts of clinical research and drug development
- Strong working knowledge of EDC, IVR and CTMS systems
- Ability to handle and prioritize multiple studies and projects. Ability to work effectively in a team/matrix environment. Ability to understand technical, scientific and medical information
- Demonstrated strengths in planning, organizational, project management, analytical skills, oral and written communication, time management, conflict management, problem solving, attention to detail, and interpersonal skills
- Ability to travel 70-80%
- BA/BS or RN, preferably in the Life Sciences
To be a best-fit your strengths must include
Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
Problem-Solvers. As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.