Sr Cra Ii - Sponsor Dedicated - Rare Disease (Home-Based, East Coast Of Us)

4+ years

$72,540 to $145,000

Remote, USA

10 Aug. 2, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Description

Senior Clinical Research Associate II

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities.

Our Clinical Development model places the customer and the patient at the center of everything we do. We continuously seek ways to simplify and streamline our work to make Syneos Health easier to work with and for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies because we are passionate about changing lives.

Discover what our 29,000 employees across 110 countries already know: WORK HERE MATTERS EVERYWHERE.

Why Syneos Health

We are passionate about developing our people through career development and progression, supportive and engaged line management, technical and therapeutic area training, peer recognition, and a total rewards program.
We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture unites us globally, and we are dedicated to taking care of our people.
We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diverse thoughts, backgrounds, cultures, and perspectives – we create a place where everyone feels like they belong.

Job Responsibilities

Perform site qualification, site initiation, interim monitoring, site management, and close-out visits (on-site or remotely) ensuring compliance with regulatory, ICH-GCP, and/or Good Pharmacoepidemiology Practices (GPP) and protocols.
Use judgment and experience to evaluate site and staff performance, providing recommendations for site-specific actions; immediately communicate/escalate serious issues to the project team and develop action plans.
Maintain a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
Verify the informed consent process for each subject/patient, ensuring confidentiality and assessing factors affecting safety and data integrity, such as protocol deviations/violations and pharmacovigilance issues.
Conduct Source Document Review and verify clinical data accuracy and completeness via review of site source documents and medical records.
Apply query resolution techniques remotely and on-site, driving query resolution to closure within agreed timelines.
Utilize available hardware and software for effective clinical study data review and capture.
Verify site compliance with electronic data capture requirements and manage investigational product (IP) inventory, reconciliation, and reviews for storage and security.
Routinely review the Investigator Site File (ISF) for accuracy, timeliness, and completeness, ensuring the site is aware of archiving requirements in accordance with local guidelines and regulations.
Document activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan.
Support subject/patient recruitment, retention, and awareness strategies and enter data into tracking systems to track all observations, ongoing status, and action items to resolution.
Understand project scope, budgets, and timelines for own and others’ activities in the clinical team, managing site-level activities/communication to ensure project objectives, deliverables, and timelines are met.
Quickly adapt to changing priorities to achieve goals/targets.
Act as a primary liaison with study site personnel or collaborate with Central Monitoring Associates.
Ensure all assigned sites and project-specific site team members are trained and compliant with applicable requirements.
Prepare for and attend Investigator Meetings and/or sponsor face-to-face meetings.
Participate in and may lead global clinical monitoring/project staff meetings and attend clinical training sessions as required.
Provide guidance at the site and project level towards audit readiness standards and support preparation for audit and required follow-up actions.
May provide direct supervision, training, and/or mentorship to more junior level CRAs and perform training and sign-off visits for junior CRA staff.
May be mentored and assigned lead tasks under supervision of an experienced Clinical Operations Lead (COL) or operational line manager, including participation in business development proposals and/or defense meetings.
For Real World Late Phase (RWLP), the Sr. CRA II will use the business card title of Sr. Site Management Associate II, with additional responsibilities including site support throughout the study lifecycle, knowledge of local requirements for real-world late phase study designs, chart abstraction activities, and data collection.

Qualifications

Bachelor’s degree or RN in a related field or equivalent combination of education, training, and experience.
Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
Demonstrated proficiency in computer skills and the ability to embrace new technologies.
Excellent communication, presentation, and interpersonal skills with a moderate level of critical thinking skills.
Ability to manage required travel of up to 75% on a regular basis.

Get to Know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

Additional Information

Tasks, duties, and responsibilities listed in this job description are not exhaustive. The Company may assign other tasks, duties, and job responsibilities at its sole discretion and with no prior notice.
Equivalent experience, skills, and/or education will also be considered, and the Company will determine what constitutes equivalent qualifications.
Nothing contained herein should be construed to create an employment contract.
The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants in performing the essential functions of the job.
Syneos Health has a voluntary COVID-19 vaccination policy. We strongly encourage all employees to be fully vaccinated. Additionally, certain local governments or Syneos Health customers may have vaccine requirements that apply to some of our employees. These employees are required to submit proof of vaccination to Syneos Health and maintain compliance with these requirements.

Benefits

At Syneos Health, we believe in providing an environment and culture in which our people can thrive, develop, and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position include a company car or car allowance, health benefits (medical, dental, and vision), company match 401k, eligibility to participate in the Employee Stock Purchase Plan, eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Eligibility for paid sick time may vary depending on where you work, in compliance with all applicable federal, state, and municipal paid sick time requirements.

The annual base salary for this position ranges from $72,540 to $145,000. The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role.

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