Work Schedule Standard (Mon-Fri) Environmental Conditions Office
Job Description
Are you an experienced clinician interested in transitioning your career into the CRO industry? Your expertise can make a valuable contribution to our home-based, traveling Clinical Research Associate (CRA) opportunities, supporting onsite clinical monitoring of ongoing studies.
Thermo Fisher Scientific has global resources, formal training programs, and focused support available to fast track your career transition. Leverage your existing skills and our development tools for successful entry into a CRA pathway.
Along your new career journey, enhance your professional development by expanding your exposure to a vast array of therapeutic areas and innovative clinical trials. Advance further through the CRA career pathway when you are ready, at your own pace with flexible, regular promotion cycles available for CRAs at Thermo Fisher Scientific.
By applying here, you are expressing interest in our Clinician to CRA Program opportunities. Please review qualifications carefully – if you already have clinical monitoring experience, we invite you to explore our other experienced CRA postings.
Summarized Purpose:
Performs and coordinates different 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. 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. Detailed tasks and responsibilities assigned to role are outlined in the task matrix.
Essential Functions:
· Monitors investigator sites with a risk-based monitoring approach. · Applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventative actions to bring the site into compliance and decrease risks. · Ensure data accuracy through Source Data Review (SDR), Source Data Verification (SDV) and Case Report Form (CRF) review as applicable through on-site and remote monitoring activities. · Assesses 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 follows 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 shared responsibility with other project team members on issues/findings resolution. · Investigates and follows-up on findings as applicable. · Participates in investigator meetings as necessary. · May help to identify 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. · Performs 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. · Provides trial status tracking and progress update reports to the team as required. · Ensures study systems are complete, accurate and updated per agreed study conventions (e.g. Clinical Trial Management System (CTMS)). · Facilitates effective communication between investigative sites, the client company and internal project teams through written, oral and/or electronic contacts. · Responds to company, client and applicable regulatory requirements/audits/inspections. · Maintains and completes administrative tasks such as expense reports and timesheets in a timely manner. · Contributes to the project team by assisting in preparation of project publications/tools and sharing ideas/suggestions with team members. · Contributes to other project work and initiatives for process improvement, as required. · Travel requirement >75%.
Qualifications
· Clinicians such as RNs, APRNs, PA’s, MDs, Research Nurse or Clinical Research Coordinator with clinician certification or equivalent and relevant formal academic/vocational training. · Comprehensive experience as a clinician in a healthcare environment (comparable to at least 2 years) that provides transferable knowledge, skills, and abilities to perform the job in a clinical research environment. · Expertise in a therapeutic area including, but not exclusive to Hematology/Oncology (solid tumor – Breast/Prostate) (Leukemias), CAR-T and Cell Therapy, Rare Disease, Endocrinology/Diabetes, Ophthalmology and Neurology (Alzheimer’s, Epilepsy), Cardiology, Infectious Disease, Respiratory/Pulmonology, Internal Medicine, ICU, or Critical Care (comparable to at least 2 years).
In some cases, the combination of education, training and experience provides the individual with the required knowledge, skills and abilities to do the job.
Knowledge, Skills and Abilities:
· Basic medical/therapeutic area knowledge and understanding of medical terminology · Ability to attain and maintain a working knowledge of ICH GCPs and applicable regulations and procedural documents · Good oral and written communication skills, with the ability to communicate effectively with medical personnel · Good interpersonal skills · Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers’ underlying issues · Good organizational and time management skills · Ability to remain flexible and adaptable in a wide range of scenarios · Well-developed critical thinking skills, including but not limited to critical mindset, in-depth investigation for appropriate root cause analysis and problem solving · Ability to manage Risk Based Monitoring concepts and processes · Ability to work in a team or independently as required · Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software · Good English language and grammar skills
Working 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:
· Work is performed in an office/ laboratory/clinical/and/or home office environment with exposure to electrical office equipment · Frequent drives to site locations. · Frequent travel, generally 60-80% but more for some individuals · May also include extended overnight stays · Exposure to fluctuating and/or extreme temperatures on rare occasions · Must be able to comply with specific sponsor/client/site requirements, even if not required by Thermo Fisher Scientific (e.g., disclosure of vaccination status, or other personal information). On some occasions, this information may be required to be provided directly to sponsor/client/site
Compensation and Benefits The salary range estimated for this position based in California is $80,000.00–$133,000.00. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:
- A choice of national medical and dental plans, and a national vision plan, including health incentive programs
- Employee assistance and family support programs, including commuter benefits and tuition reimbursement
- At least 120 hours 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, and short- and long-term disability in accordance with company policy
- Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
- Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards
