Senior clinical research associate job description

At Premier Research, we help biotech and specialty pharma companies transform life-changing ideas into reality. What we do is profoundly connected to saving and improving lives, and we recognize our staff members are the most valuable asset in delivering success. Inspiring and nurturing staff to do their best work means a better, healthier future for all. We're a community of 2,000 people in more than 20 countries delivering unmatched expertise, operational skills, and dedication to meet the most challenging needs facing clinical trials today.
We're looking for a Senior Clinical Research Associate to join our Clinical Monitoring team in the Northeast region of North America. As a member of the Premier Research team, you'll help create tangible solutions for patients in need while building cross-functional partnerships that enable your growth and success.

What you'll be doing:
Perform monitoring activities (both on-site and remote) for Phase I-IV clinical trials, as well as device trials with opportunities to work in such therapeutic areas as: cardiovascular, oncology, pediatrics, rare disease, women's health, dermatology, neurology, etc. Ensure the validity, correctness, and completeness of clinical data collected at sites with a focus on data integrity and patient safety as dictated by trial protocol, ICH-GCP/ISO 141155, and customer requirements. Serve as the primary point of contact for investigative sites, manage query resolution, support Trial Master File activities, participate in Investigators' Meetings, and complete other project tasks in accordance with study timelines and budget. Identify and escalate potential risks and possible retraining opportunities for investigative sites. Schedule and plan day-to-day activities to include study monitoring visits, timely completion of high-quality trip reports, and active management of all deliverables.
What we are searching for:

Bachelor's degree, or local equivalent, in a clinical, biological, scientific, or health-related field or its international equivalent 4+ years of independent on-site monitoring experience with all types of site visits Completion of a CRA training program through a CRO Ability to travel to meet the requirement of 8 DOS You must live in the following states: MA, CT, DC, DE, ME, MD, NH, NJ, NY, OH, PA, RI, VT
Why choose Premier Research?

Premier Research is more than a company - it's a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need. Our cultural anchors - Caring & Empathy, Empowerment, Aspiration, One Team - mirror the flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location. Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.
At Premier Research, our mission is to improve healthcare by transforming life-changing ideas into new medical treatments that address the unmet needs of a diverse global population. Achieving this is impossible without creating a culture where our employees are given the power to think creatively, challenge ideas, and solve complex problems fearlessly.

Through a commitment to diversity, equity, inclusion, and empowerment, we strive to create a community of belongingness where our differences are welcomed and celebrated. It fuels our innovation and better connects us to the patients, physicians, and customers we serve.

Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status.

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The Division of Cardiothoracic Surgery is recruiting a Senior Clinical Research Associate to managing the Aortic Surgery Patient Database, a database of 10,000+ patients and 15,000+ surgeries. The position will be responsible for using data exporting software (QlikView) to output patient data from the aortic database, which will be used for drafting presentations, publications, and completing feasibility questionnaires for clinical studies. The Senior Clinical Research Associate will work closely with the Division of Cardiothoracic Surgery research team as well as medical students, residents, and faculty both within and outside the division to complete outcomes based research projects.

Acts as an administrative contact and coordinator for national and international research studies. -Exports and formats data files, using QlikView and Excel software, for the purposes of completing manuscripts and presentations for the division
Coordinates the software transition from BCM IT to Office of Research IT. Utilizes QlikView software to complete clinical study feasibility questionnaires for investigators in the division Utilizes R and SPSS software to complete statistical analyses for manuscripts (survival, competing risk, and logistic regression analyses) Completes literature reviews for the division's publications and presentations Works with Research IT on continual improvements to the ASPD, and improving the data export process through a new reporting system to decrease use of QlikView



Minimum Qualifications



Bachelor's degree. Four years of relevant experience.



Preferred Qualifications



Bachelor's degree in a Basic Science or related field, including those related to healthcare, epidemiology, data science, statistical analysis Master's degree in Public Health or related field Advanced knowledge of Microsoft Office Excel, including basic statistical analysis, the use of formulas, conditional formatting, data merging, and preparation of data for presentation as statistical figures Working knowledge of basic statistical programs to perform descriptive, comparative, and other analyses Experience with data export, data transformation, and data merging Ability to combine data to create composite variables Coursework in statistics, biometry, or data analytics Familiarity with basic anatomy and medical terminology Ability to draft one or more paragraphs to describe project-specific statistical methods Ability to transfer statistical results into academic manuscripts Ability to process complex information to resolve data discrepancies through recognition of errors and formulating a troubleshooting process


Baylor College of Medicine requires employees to be fully vaccinated -subject to approved exemptions-against vaccine-preventable diseases including, but not limited to, COVID-19 and influenza.

Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.

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CA; SN

The Senior Clinical Research Associate is assigned to one clinical trial and a clinical trial team and leads various clinical operational aspects of the trial management in collaboration with other clinical team members. Responsible for providing expert and overall support to clinical study teams in matters related to vendor oversight, investigational site management and other study related activities, including; study start-up, vendor selection and management, interim study monitoring and management as well as trial closeout activities.
Duties (may include but are not limited to):
·Perform onsite monitoring activities and/or ensure adherence to the clinical monitoring plan
Manage study sites and train the clinical site staff to ensure protocol and regulatory compliance and quality of data Independently oversee external CRAs, providing clear communication and direction with regards to the clinical protocol and general trial support Participate in the CRO selection and management May assist in or be responsible for development of protocols, informed consents, case report forms, monitoring plans, edit specifications, and clinical study reports Assist with projection and management of clinical supplies Coordinate and/or participate in investigator meetings Responsible for updating study timelines and metrics Responsible for listing review and resolution of queries during database lock and in preparation of final study reports Participate in and/or chair meetings or conference calls with CROs, CRAs and cross-functional study teams Provide mentoring to CRAs and Clinical Trial Assistants (CTA's)

Requirements:
Bachelor's degree in a relevant scientific discipline or equivalent At least 5+ years of relevant experience with at least 2 years in a CRA functional role in the pharmaceutical industry, Biotech or equivalent Knowledge of GCP and ICH guidelines required Excellent communication and interpersonal skills Detail and quality oriented Able to work independently and within a team Able to perform assignments with general instructions Able to solve complex problems, prioritize multiple tasks, plan proactively and accomplish goals within project Experience developing tools and processes that increase measured efficiencies of the project Strong computer skills in MS Word, Excel, Outlook, and PowerPointMust be willing to travel (25 -30%)

FibroGen is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender identity/expression, creed, national origin/ancestry, age, alienage or citizenship, status, age, sex, sexual orientation, marital or domestic/civil partnership status, disability, veteran status, genetic information, or any other basis protected by law.FibroGen will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the San Francisco Fair Chance Ordinance.

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