FSP Sr CRA - Medical Device - East Coast

ThermoFisher Scientific; Guilford (CT); On-site; USD 89,000 - 145,000; Full time

Benefits offered by this job

Medical and dental plans

Vision plan

Paid time off

Holidays

Parental leave

Retirement plan

Employee stock purchase plan

Tuition reimbursement

Job summary

Thermo Fisher Scientific in the United States is seeking a Senior Clinical Research Associate (Level I/II) to join our global clinical operations team. You will conduct remote or on-site monitoring to assess protocol compliance, ensure subject safety, and manage essential regulatory documentation across multiple sponsors and monitoring environments.

The role requires strong knowledge of ICH-GCP, attention to data quality, and excellent communication skills.

Qualifications

• Bachelor's degree in life sciences or RN or equivalent.
• 2+ years clinical research monitoring experience.
• Valid driver's license.

Responsibilities

• Conduct remote or on-site site monitoring visits per protocol.
• Ensure data accuracy through SDR and CRF review.
• Prepare reports and communicate findings to the Clinical Team Manager.
• Maintain essential documents per ICH-GCP.
• Support investigator meetings and site start processes.

Skills

Clinical monitoring

ICH GCP

Critical thinking

Communication skills

Teamwork

Organizational skills

MS Office

English proficiency

Education

Bachelor's degree life sciences

Registered Nursing (RN)

Tools

CTMS

MS Office

EDC

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join Us as a Senior Clinical Research Associate (Level I/II) – Make an Impact at the Forefront of Innovation

We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

As part of our global team, you’ll have the opportunity to perform and coordinate all aspects of the clinical monitoring and site management process. As a Senior Clinical Research Associate (Level I), you'll conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation. You will manage procedures and guidelines from different sponsors and/or monitoring environments (i.e., FSO, FSP, Government, etc.). Acting as a site processes specialist, you will ensure 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. You will ensure audit readiness and develop collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to your role are outlined in the task matrix.

What You’ll Do:

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/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 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.

Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members. Performs additional study tasks as assigned by CTM (e.g. trip report review, newsletter creation, lead CRA team calls etc).

Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.

Responds to company, client and applicable regulatory requirements/audits/inspections.

Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.

Contributes to other project work and initiatives for process improvement, as required.

Education and Experience Requirements:

Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years 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.

• Multiple Options available in either Medical Devices OR Oncology

Knowledge, Skills and Abilities:

Effective clinical monitoring skills

Demonstrated understanding of medical/therapeutic area knowledge and medical terminology

Excellent understanding and demonstrated application of ICH GCPs, applicable regulations and procedural documents

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 manages Risk Based Monitoring concepts and processes

Effective oral and written communication skills, with the ability to communicate effectively with medical personnel

Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers’ underlying issues

Effective interpersonal skills

Strong attention to detail

Effective organizational and time management skills

Ability to remain flexible and adaptable in a wide range of scenarios

Ability to work in a team or independently as required

Good computer skills: proficient knowledge of Microsoft Office and the ability to learn appropriate software

Good English language and grammar skills

Good presentation skills

Working Conditions and Environment:

Working Conditions and Environment:

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 biological fluids with potential exposure to infectious organisms.

Personal protective equipment required such as protective eyewear, garments and gloves.

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 Indiana is $88,600.00–$144,900.00.

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

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.