Job Description

This home-based position is located in Alabama, Arkansas, Florida, Kentucky, Louisiana, Mississippi, South Carolina, Tennessee, or West Virginia. (Note: Due to a system upgrade the primary location for this opening is reflected as North Carolina - unfortunately this position is not open in North Carolina at this time.) Ideal candidates will possess five or more years of onsite monitoring experience and experience monitoring oncology, cell or gene therapy, rare diseases, pulmonary artery hypertension or neurology. This position requires overnight travel either regionally or nationally, dependent on business needs. At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future. Our global Clinical Operations colleagues within our PPD® clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts. Together, we help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies. Discover Impactful Work: Performs and coordinates all aspects of the clinical monitoring and site management process. Conducts remote or on- site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from different sponsors and/or monitoring environments (i.e. FSO, FSP, Government, etc.). Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability. Ensures audit readiness. Develops collaborative relationships with investigational sites and client company personnel. Assists project manager or clinical team manager on assigned projects and will take a lead role where required. Supports the line manager to mentor, train and contribute to the development of junior clinical team members. Detailed tasks and responsibilities assigned to role are outlined in the task matrix. A day in the Life: Monitors investigator sites with particular ability to manage complex studies and/or challenging sites using a risk-based monitoring approach, applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable Provides updates on potential trends noted across multiple sites and discusses potential strategies for their management to the Clinical Team Manager (CTM). Supports Clinical Team Management, including or Clinical Manager of CRAs (CMCRA), to mentor, train and contribute to the development of junior CRAs. Assists in project specific training for the clinical team where necessary. Identifies areas for potential process improvements, share potential solutions & implement where appropriate. Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System, CTMS). Performs QC check of reports generated from CTMS system where required. Participates in investigator meetings as necessary. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Ensures trial close out and retrieval of trial materials. Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications. Responds to company, client and applicable regulatory requirements/audits/inspections. Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner. #LI-JN1 #LI-Remote Keys to Success: Education Bachelor's degree in life related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification. Experience Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ as a clinical research monitor). Valid driver's license where applicable. In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills, Abilities Expert clinical monitoring skills Expert knowledge of FDA guidelines, ICH GCPs, applicable regulations and procedural documents Excellent critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving Proficient in Risk Based Monitoring concepts and processes Skills to mentor and train other monitors in a positive and effective manner Demonstrated ability to evaluate medical research data and proficient knowledge of medical terminology Excellent oral and written communication skills Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers’ underlying issues Excellent interpersonal skills Excellent organizational and time management skills Strong attention to detail Ability to remain flexibile and adaptable in a wide range of scenarios Excellent team player with team building skills Effective presentation skills Ability to work independently as required Ability to utilize problem-solving techniques applicable to constantly changing environment Good computer skills: proficient knowledge of Microsoft Office and the ability to learn appropriate software Good English language and grammar skills Work Environment Thermo Fisher Scientific values the health and well-being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role: Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. Able to work upright and stationary for typical working hours. Able to work in non-traditional work environments. Able to use and learn standard office equipment and technology with proficiency. Able to perform successfully under pressure while prioritizing and handling multiple projects or activities. May have exposure to potentially hazardous elements typically found in healthcare or laboratory environments. This role requires independent travel up to 80%, inclusive of traveling in automobiles, airplanes, and trains. The salary range estimated for this position is $67,000 annually - $145,000 annually (if living in NYC up to $150,000).This position will also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. Actual compensation will be confirmed in writing at the time of offer. We offer a comprehensive Total Rewards package that our US colleagues and their families can count on, which generally includes: A choice of national medical and dental plans, and a national vision plan A wellness program, and valuable health incentive opportunities for company contributions to a Health Reimbursement Accounts (HRAs) or Health Savings Account (HSA) Tax-advantaged savings and spending accounts and commuter benefits Employee assistance program Paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, short- and long-term disability, and volunteer time off in accordance with company policy