2nd shift quality control specialist (contract) 28670

Alliance for Clinical Trials in Oncology

<div>
 
 The Alliance for Clinical Trials in Oncology Foundation (Foundation) is a foundation created to enhance and expand the ability of the Alliance for Clinical Trials in Oncology (Alliance) to conduct cancer clinical research and address important treatment questions through large-scale clinical trials. Through efforts of the Foundation in support of the Alliance, clinical trials and laboratory research are conducted to discover new or improved ways to prevent, treat, and cure many types of cancer, including leukemia and lymphoma, and cancers of the breast, prostate, lung, and gastrointestinal (GI) tract, and help educate the medical community on methods of cancer diagnosis, treatment, and prevention.
 
 
 In May 2014, the Foundation created the Alliance Foundation Trials, LLC (AFT), respectively, a wholly-owned subsidiary of the Foundation. AFT was also created to conduct cancer clinical research and address medical care and treatment through large-scale clinical trials involving various industry-related partners.
 
 
 The Alliance Foundation Trials (AFT) is seeking a Clinical Research Associate (CRA) to support the management and execution of clinical trial operations across AFT studies. This role is responsible for key site management and study start-up activities, including feasibility assessments, site selection support, maintenance of trial master files (eTMF), and oversight of clinical trial systems such as CTMS. The CRA will collaborate closely with CROs, vendors, and investigative sites to ensure studies are conducted in compliance with ICH GCP guidelines and organizational standards, while supporting studies from start-up through ongoing maintenance. Come join an organization full of passionate, team-oriented professionals driven to change the face of cancer.
 
 
 Benefits of working at the Alliance for Clinical Trials in Oncology Foundation{{:}}
 
 <ul>
 <li>
 8 weeks of paid time off (including PTO, sick, and holidays) during year one
 </li>
 <li>
 Medical, Dental &amp; Vision plans with a 100% employer-paid option for employees
 </li>
 <li>
 Tuition reimbursement stipends
 </li>
 <li>
 Continuing Education
 </li>
 <li>
 3% employer match for retirement investments
 </li>
 <li>
 Annual Employee Performance Bonus Program
 </li>
 <li>
 Annual Cost of Living Adjustment
 </li>
 <li>
 50% commuter reimbursement
 </li>
 <li>
 Healthy Work/Life balance and flexibility
 
 </li>
 </ul>
 
 
 ROLE AND RESPONSIBILITIES
 
 
 
 &bull; Assist operations team in supporting the Alliance member sites and escalate site related issues when necessary.
 
 
 &bull; Send, track, and review study-specific and global feasibility questionnaires.
 
 
 &bull; Assist with site selection and recruitment by generating site identification reports (e.g., site accrual); collecting, reviewing and tracking site feasibility/credentialing documentation and follow-up on site accruals accordingly.
 
 
 &bull; Track training information and issue trainings for sites and contacts.
 
 
 &bull; Collection of essential documents related to study start-up and review IP release packages.
 
 
 &bull; Prepare for and execute Investigator meetings and other site training programs.
 
 
 &bull; Assist with creation of start-up plans and templates.
 
 
 &bull; Ensure proper and timely filing of all relevant study documents into the eTMF on an ongoing basis to ensure compliance with applicable work instructions, SOPs and ICH GCP guidelines and AFT expectations.
 
 
 &bull; Perform routine review of filing procedures to ensure adherence to current quality guidelines at all times.
 
 
 &bull; Accurately enter and manage data within the Clinical Trial Management System (CTMS) by{{:}} tracking completed training information that could carry over to other studies; maintaining site information and rosters; reviewing monitoring reports to identify deficiencies, reviewing adequacy of issue escalation and issue resolution; and provide feedback to appropriate CRO contacts.
 
 
 &bull; Participate in co-monitoring activities.
 
 
 &bull; Communicate with CROs, vendors, and/or study sites as necessary to support the study, which includes monitoring email accounts related to studies.
 
 
 &bull; Conduct regulatory review of ICF changes and coordinate review by Executive Officer and contracts team
 
 
 &bull; Coordinate study related meetings; take detailed minutes at meetings on decisions and action items and distribute to the team, as assigned.
 
 
 &bull; Other related duties as assigned to meet departmental and company objectives.
 
 
 
 
 Requirements
 
 
 
 
 
 QUALIFICATIONS AND EDUCATION REQUIREMENTS
 
 
 
 &bull; A minimum of a BA/BS degree is required.
 
 
 &bull; Degree in a health or science major preferred.
 
 
 &bull; 2 - 4 years relevant experience in biotech, pharma, and/or CRO, including 1 year of clinical research industry experience.
 
 
 &bull; Working knowledge of clinical monitoring responsibilities and procedures.
 
 
 &bull; Previous experience with eTMF, CTMS, and IRT clinical trial systems is strongly preferred.
 
 
 &bull; Proficient in Microsoft Office Suite, especially Word and Excel.
 
 
 
 PREFERRED SKILLS
 
 
 
 &bull; Strong organizational skills and ability to prioritize workload to meet tight deadlines in a fast-paced and dynamic work environment.
 
 
 &bull; Strong interpersonal, written, and verbal communication skills.
 
 
 &bull; Flexible and adaptable to a small business workplace environment.
 
</div>

Clinical Research Associate

AbbVie

<div>Company Description 
About AbbVie
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 remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. 
Job Description 
We are hiring in Boston, Pittsburg &amp; Michigan
Advance AbbVie's pipeline by striving for excellence in clinical research, turning science into medicine for our patients and leveraging new advanced capabilities to drive industry leading performance. 
Partners with the investigator and site staff for meaningful and effective engagements positioning AbbVie as the choice in clinical trials. 
Focus on site clinical research that ensures appropriate conduct of the trial while driving improvement in data integrity, compliance, overall study performance and customer experience.
Responsibilities<ul><li>
Considered as the primary point of contact for the investigative site. High level of competency or experience in providing contextual information on the clinical trials, connects stakeholder to the investigative sites and strengthens AbbVie&rsquo;s positioning.</li><li>
Aligns, trains and motivates the site staff and principal investigator on the goals of the clinical trial program, protocol and patient treatment principles for the trial ensuring a trusted partnership.</li><li>
Conducts site evaluation, site training, routine, and site closure monitoring activities with compliance to the protocol and monitoring plans, in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and quality standards, ensuring safety and protection of study subjects.</li><li>
Advanced understanding of site engagement and ability to customize site engagement strategy for assigned study (ies). Gather local/site insights and utilize site engagement tools such as the Customer Relationship Management (CRM) tool, to report/track progress and measure impact of that strategy.</li><li>
Advanced level of competency connecting the study protocol, scientific principles and clinical trial requirements to the day-to-day clinical trial execution activities. Evaluate and ensure effective recruitment and retention techniques/plans based on the patient disease journey. 
Develop solid knowledge of therapeutic area, asset and clinical landscape / patient journey to enable successful patient recruitment and overall protocol compliance.</li><li>
Possesses experienced level of competency to mentor and train less experienced CRAs on various aspects of work and provides input into their development. 
May participate in global/local task forces and initiatives. Responsible for activities as assigned by manager.</li><li>
Responsible for continuous 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.</li><li>
Advanced ability to think critically to resolve site risk signals while having robust understanding of site processes to drive study execution. Ensures preventative and corrective action plans are put into place, as needed, to mitigate risk and promote compliance using a customer centric approach.</li><li>
Identifies, evaluates and recommends new/potential investigators/sites on an on going basis. Potential sites may be identified through networking or internal AbbVie requests to assist in the placement of planned clinical studies with qualified investigators.</li><li>
Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel. 
Ensures audit and regulatory inspection readiness at assigned clinical site at all times. 
Manages investigator payments as per executed contract obligations, as applicable.</li></ul> 

Qualifications 
<ul><li>
Appropriate tertiary qualification in health related disciplines (Medical, Scientific, Nursing) preferred.</li><li>
Minimum of 1 year of clinically related experience, of which a period of 6 months is required in clinical research monitoring of investigational drug or device trials. Familiar with risk‐based monitoring approach, onsite and offsite monitoring.</li><li>
Knowledge of appropriate therapeutic area indications is preferred with the ability to understand and apply scientific concepts as they relate to the conduct of clinical trials.</li><li>
Advanced knowledge on existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies.</li><li>
Demonstrate strong cross-functional collaboration skills among internal and external stakeholders.</li><li>
Demonstrate strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.</li><li>
Advanced ability to leverage technology, tools and resources to provide customer centric support based on the health of the site.</li><li>
Strong interpersonal skills with excellent written, verbal, active listening and presentation skills, with ability to establish and leverage site relationships and trusted partnerships through engagement, motivation, and training.</li><li>
Ability to use functional expertise with appropriate guidance, leverage critical thinking skills and apply good judgement to address clinical site issues.</li><li>
Acts with integrity in accordance with AbbVie code of business conduct and leadership values. Self-motivated individual focused on delivering timely and quality outcomes in a fast-paced environment.</li></ul> 

Additional Information 
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
<ul><li>The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this roleat the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on manyfactors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
</li><li>We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
</li><li>This job is eligible to participate in our short-term incentive programs.
</li></ul>Note: No amount of pay is considered to be wages or compensation until such amount isearned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that areallocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company&rsquo;s sole and absolutediscretion, consistent with applicable law.<div></div>
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US &amp; Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US &amp; Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html</div>

Clinical Research Associate II - Oncology (Remote US - Multiple Openings)

Explore 2+ Cra in Boston this June. Find roles across top companies and apply now to boost your career.

2 cra jobs In Boston

Clinical Research Associate

Clinical Research Associate II - Oncology (Remote US - Multiple Openings)