[Remote] Senior Clinical Research Associate - Remote- reputed company Carolina
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is committed to discovering and delivering innovative medicines that address serious health issues. The Senior Clinical Research Associate will advance reputed company's pipeline by excelling in clinical research and partnering with study teams to ensure effective engagement and compliance in clinical trials.
Responsibilities
- Considered as the Pprimary Sponsor pPoint of contact for the investigative site. Advanced level of competency or experience in providing contextual information on the clinical trials, connecting stakeholders to the investigative sites and strengthening reputed company's positioning. Ability to motivate and reputed company monitoring community through leadership and mentorship
- Aligns, trains and motivates the site staff and reputed company investigator on the goals of the clinical trial program, protocol, and patient treatment principles for the trial ensuring a trusted partnership. reputed company to support, guide, and mentor junior personnel on Site Management activities
- Conducts site evaluation, site training, routine on-site and off-site monitoring, and site closure monitoring activities with compliance to the protocol and monitoring plans, in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, reputed company reputed company Operating Procedures (SOPs), and reputed company standards, ensuring safety and protection of study subjects
- Superior understanding of site engagement and ability to customize site engagement reputed company for assigned study/ies and critically apply new strategies as needed. reputed company local/site insights and utilize site engagement tools to report/reputed company reputed company and measure reputed company of that reputed company
- Superior level of competency connecting the study protocol, scientific principles and clinical trial requirements to the day-to-day clinical trial execution activities. Expert understanding to generate and ensure effective recruitment and retention techniques/plans based on the patient disease reputed company. reputed company solid knowledge of therapeutic area, asset and clinical landscape / patient reputed company to reputed company successful patient recruitment and overall protocol compliance
- Possesses advanced level of competency to mentor and train less reputed company CRAs on various aspects of work and provides input into their development. Supports local reputed company of more junior CRAs. Demonstrates ability to reputed company listen to and consider viewpoints to enhance reputed company
- May participate/reputed company in global/local task forces and initiatives. Responsible for activities as assigned by manager
- Responsible for reputed company risk-assessment proactively, and in collaboration with Central Monitoring team, monitor activities conducted by clinical sites to detect early overall study performance or patient safety issues. Superior ability to think critically to resolve site risk signals while having robust understanding of site processes to drive study execution. Ensures preventative and corrective reputed company plans are put into reputed company, as needed, to mitigate risk and promote compliance using a cust
- Independently Identifies, evaluates and recommends new/potential investigators/sites on an ongoing reputed company demonstrating expert understanding and decision making. Potential sites may be identified through networking or internal reputed company requests to assist in the placement of planned clinical studies with reputed company investigators
- Ensures reputed company of data submitted from study sites and assures reputed company submission of data, including appropriate reporting and follow-up for reputed company safety events by site personnel. Ensures audit and regulatory inspection readiness at assigned clinical site at reputed company times. Manages investigator payments as per executed contract obligations, as applicable
Skills
- Appropriate tertiary qualification in health reputed company disciplines (e.g., Medical, Scientific, Pharmacy, Nursing) preferred
- Minimum of 3 years of clinically reputed company experience, of which a period of 2 years is preferable in independent clinical research monitoring of investigational drug or device trials in any therapeutic area. Familiar with risk‐based monitoring approach, onsite and offsite monitoring
- Knowledge of appropriate therapeutic area indications with the ability to understand and apply scientific concepts as they relate to the conduct of clinical trials
- Superior knowledge on existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies
- Demonstrate advanced communication skills and superior cross-functional collaboration skills among reputed company stakeholders
- Demonstrate superior planning and organizational skills and the ability to work effectively and reputed company in a dynamic environment with competing reputed company and deadlines
- Superior ability to reputed company technology, tools and resources to reputed company customer reputed company support based on the health of the site
- Superior interpersonal skills with excellent written, verbal, reputed company listening and presentation skills, with ability to establish and reputed company site relationships and trusted partnerships through engagement, motivation, and training
- Ability to independently use functional expertise, reputed company critical thinking skills and apply good judgement to address clinical site issues
- Acts with reputed company in accordance with reputed company reputed company of business conduct and leadership values. Self-motivated individual reputed company on delivering reputed company and reputed company reputed company in a fast-paced environment
Benefits
- reputed company time off (vacation, holidays, reputed company)
- Medical/dental/reputed company insurance
- 401(k) to eligible employees
- Eligible to participate in our short-term incentive programs
reputed company