Talent.com
Clinical Research Associate II / Sr CRA - Full Service - (Home-Based in Central US)
Clinical Research Associate II / Sr CRA - Full Service - (Home-Based in Central US)Syneos Health/ inVentiv Health Commercial LLC • Morrisville, NC, United States
Clinical Research Associate II / Sr CRA - Full Service - (Home-Based in Central US)

Clinical Research Associate II / Sr CRA - Full Service - (Home-Based in Central US)

Syneos Health / inVentiv Health Commercial LLC • Morrisville, NC, United States
[job_card.variable_days_ago]
[job_preview.job_type]
  • [job_card.temporary]
  • [filters.remote]
[job_card.job_description]

Clinical Research Associate II / Sr CRA - Full Service - (Home-Based in Central US)

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 brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work 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 to change 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 total rewards program.
  • We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what 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 diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.

Job Responsibilities

  • Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and / or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates / escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH / GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs / processes.
  • Verifies the process of obtaining informed consent has been adequately performed and documented for each subject / patient, as required / appropriate. Demonstrates diligence in protecting the confidentiality of each subject / patient. Assesses factors that might affect subject / patient's safety and clinical data integrity at an investigator / physician site such as protocol deviation / violations and pharmacovigilance issues.
  • Per the Clinical Monitoring / Site Management Plan (CMP / SMP) : Assesses site processes. Conducts Source Document Review of appropriate site source documents and medical records. Verifies required clinical data entered in the case report form (CRF) is accurate and complete. Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines. Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture. Verifies site compliance with electronic data capture requirements.
  • May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects / patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP / local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released / returned.
  • Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator / physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
  • Documents 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. Supports subject / patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
  • For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets.
  • May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements
  • Prepares for and attends Investigator Meetings and / or sponsor face to face meetings. Participates in global clinical monitoring / project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
  • Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
  • Maintains a working knowledge of ICH / GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs / processes; completes assigned training as required. For Real World Late Phase, the CRA II will use the business card title of Site Management Associate II. Additional responsibilities include : Site support throughout the study lifecycle from site identification through close-out. Knowledge of local requirements for real world late phase study designs.Chart abstraction activities and data collection
  • Collaboration with Sponsor affiliates, medical science liaisons and local country staff. The SMA II may be requested to train junior staff. Identify and communicate out of scope activities to Lead CRA / Project Manager. Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations.

    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
  • Must demonstrate good computer skills and be able to embrace new technologies
  • Excellent communication, presentation and interpersonal skills
  • Ability to manage required travel of up to 75% on a regular basis
  • US ONLY : As part of your employment with Syneos Health, you may be deployed to Sites that require certain medical and other personal information to gain facility access. Pursuant to our Employee Privacy Notice, Syneos Health can provide the Sites with the information necessary for you to gain such access. Further, a Site may ask you for additional information beyond that which Syneos Health has in its possession. You are required to comply with any such Site requests as a condition of your employment with Syneos Health. Please note that failure to provide requested information may result in a Site barring you from entry, which could put your ongoing employment at risk.
  • 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 may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions / bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.

    Salary Range :

    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.

    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.

    http : / / www.syneoshealth.com

    Additional Information

    Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and / or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills / experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. 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 to perform the essential functions of the job.

    [job_alerts.create_a_job]

    Clinical Research Associate Ii • Morrisville, NC, United States

    [internal_linking.similar_jobs]
    Clinical Research Associate (CRA)

    Clinical Research Associate (CRA)

    Peachtree BioResearch Solutions • Raleigh, NC, US
    [job_card.full_time]
    Peachtree BioResearch Solutions,.CRO providing highly specialized study operations teams for pharmaceutical, biotech, and medical device companies. Formed over 15 years ago by a pharma leadership te...[show_more]
    [last_updated.last_updated_30] • [promoted]
    AI Research Scientist (Remote)

    AI Research Scientist (Remote)

    Scale AI • Raleigh, North Carolina, United States
    [filters.remote]
    [job_card.full_time]
    Join a global community of talented professionals to shape the future of AI.Earn up to $15 USD / hr and additional rewards based on quality of submission. Outlier is committed to improving the intelli...[show_more]
    [last_updated.last_updated_1_day] • [promoted]
    CRA II / Sr CRA | Full Service | Ophthalmology (Home-Based, Eastern US)

    CRA II / Sr CRA | Full Service | Ophthalmology (Home-Based, Eastern US)

    Syneos Health Careers • Morrisville, NC, United States
    [filters.remote]
    [job_card.temporary]
    CRA II / Sr CRA | Full Service | Ophthalmology (Home-Based, Eastern US).Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.We...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Travel Physical Therapy Assistant (PTA) - $1,492 per week in Dunn, NC

    Travel Physical Therapy Assistant (PTA) - $1,492 per week in Dunn, NC

    AlliedTravelCareers • Dunn, NC, US
    [job_card.full_time]
    AlliedTravelCareers is working with Triage Staffing LLC to find a qualified Physical Therapy Assistant (PTA) in Dunn, North Carolina, 28334!. Travel Rehab : Physical Therapy Dunn.Shift Details : 8H ...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    RN IV Care Specialist

    RN IV Care Specialist

    PruittHealth • Raleigh, NC, US
    [job_card.full_time]
    Registered Nurse RN IV Care Specialist.Home is where the heart is! That's why PruittHealth @ Home is committed to caring for our patients and residents, as well as providing our employees...[show_more]
    [last_updated.last_updated_variable_hours] • [promoted] • [new]
    Travel MRI Tech - $1,870 per week in Wilson, NC

    Travel MRI Tech - $1,870 per week in Wilson, NC

    Cross Country Allied • Raleigh, North Carolina, US
    [job_card.full_time]
    As an MRI technologist, you will take medical images of patients for diagnostic purposes using magnetic resonance imaging. Working in a hospital, outpatient center, private practice, imaging center ...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Clinical Research Associate ll - Oncology (North Carolina / South Carolina)

    Clinical Research Associate ll - Oncology (North Carolina / South Carolina)

    AbbVie • Raleigh, NC, US
    [job_card.full_time]
    AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkab...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Travel Nurse - RN - Home Health - $2057 / Week

    Travel Nurse - RN - Home Health - $2057 / Week

    KPG Healthcare Nursing • Lillington, NC, US
    [job_card.permanent] +1
    KPG Healthcare Nursing is seeking an experienced Home Health Registered Nurse for an exciting Travel Nursing job in Lillington, NC. Shift : Inquire Start Date : ASAP Duration : 13 weeks Pay : $2057 / We...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Travel MRI Tech - $2,111 per week in Asheville, NC

    Travel MRI Tech - $2,111 per week in Asheville, NC

    Care Career • Raleigh, North Carolina, US
    [job_card.full_time]
    MRI technologists operate magnetic resonance imaging machines in the healthcare sector.They create diagnostic images of patients according to their physicians' instructions, take patients' historie...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Travel MRI Tech - $1,798 per week in Wilson, NC

    Travel MRI Tech - $1,798 per week in Wilson, NC

    Atlas MedStaff • Raleigh, North Carolina, US
    [job_card.full_time]
    Atlas Medstaff is currently seeking candidates in the MRI Tech (MRI Tech) profession for a 13 week contract in the Wilson, North Carolina area. Atlas Medstaff is a premier staffing firm dedicated to...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Travel Physical Therapy Assistant (PTA) - $1,492 per week in Dunn, NC

    Travel Physical Therapy Assistant (PTA) - $1,492 per week in Dunn, NC

    Triage Staffing LLC • Dunn, NC, US
    [job_card.full_time]
    Travel Rehab : Physical Therapy Dunn.Shift Details : 8H Days (12 : 00 AM-12 : 00 PM).Length : 13 WEEKS 13 weeks.Apply for specific facility details.[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Travel MRI Tech - $1,672 to $1,872 per week in Wilson, NC

    Travel MRI Tech - $1,672 to $1,872 per week in Wilson, NC

    Jackson HealthPros • Raleigh, North Carolina, US
    [job_card.full_time] +1
    Jackson HealthPros is thrilled to welcome an experienced MRI Tech to our team to accurately interpret a physician’s scanning instructions, prepare and position patients for MRI procedures, and expe...[show_more]
    [last_updated.last_updated_variable_hours] • [promoted] • [new]
    Travel Physical Therapy Assistant

    Travel Physical Therapy Assistant

    Medical Solutions • Dunn, NC, US
    [job_card.full_time]
    Medical Solutions is seeking an experienced Physical Therapy Assistant for an exciting Travel Allied job in Dunn, NC.Shift : 5x8 hr days Start Date : ASAP Duration : 13 weeks.A facility in Dunn, NC is...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    AI Writing Reviewer - Remote

    AI Writing Reviewer - Remote

    Outlier • Dunn, NC, United States
    [filters.remote]
    [job_card.full_time]
    Earn up to $16 USD / hourly and work remotely and flexibly.Outlier, a platform owned and operated by Scale AI, is looking for. If you're passionate about improving models and excited by the future of ...[show_more]
    [last_updated.last_updated_variable_hours] • [promoted] • [new]
    Clinical Research Associate (CRA) - NC, VA, MD

    Clinical Research Associate (CRA) - NC, VA, MD

    ICON Clinical Research • Cary, NC, United States
    [job_card.full_time]
    Clinical Research Associate (CRA) - NC, VA, MD.ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovati...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Travel Progressive Care Unit (PCU) RN

    Travel Progressive Care Unit (PCU) RN

    Premier Medical Staffing Services • Lillington, NC, US
    [job_card.permanent]
    Premier Medical Staffing Services is seeking a travel nurse RN PCU - Progressive Care Unit for a travel nursing job in Lillington, North Carolina. Job Description & Requirements.Premier Medical ...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Travel MRI Tech - $1,622 to $1,822 per week in Wilson, NC

    Travel MRI Tech - $1,622 to $1,822 per week in Wilson, NC

    Titan Medical Group • Raleigh, North Carolina, US
    [job_card.full_time]
    BCLS / BLS - American Heart Association / ARRT(MR).Titan Medical is looking for travelers to fill a Travel MRI Tech position for a 13 week assignment in Wilson, NC! Call Titan for additional details.[show_more]
    [last_updated.last_updated_variable_hours] • [promoted] • [new]
    Travel Physical Therapy Assistant (PTA) - $1,190 to $1,434 per week in Dunn, NC

    Travel Physical Therapy Assistant (PTA) - $1,190 to $1,434 per week in Dunn, NC

    AlliedTravelNetwork • Dunn, NC, US
    [job_card.full_time]
    AlliedTravelNetwork is working with Fusion Medical Staffing to find a qualified Physical Therapy Assistant (PTA) in Dunn, North Carolina, 28334!. Travel Physical Therapy Assistant (PTA).Facility in ...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]