Clinical Research Associate II/III - US

Optimapharm; Philadelphia (Philadelphia County); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Health insurance

Pension plan

Training & development

Well-being initiatives

Career progression

Job summary

Optimapharm is seeking a CRA II/III to advance clinical research in a remote US role. You will perform site visits, monitor trials, review data, and manage budgets, with a focus on quality and regulatory compliance.

We value independence, strong communication, and the ability to work in a matrix team. Prior ICH GCP knowledge and 2+ years of monitoring experience are required for this role at Optimapharm.

Qualifications

• Bachelor's or higher in life sciences or healthcare field.
• Two+ years of independent clinical trial monitoring experience.
• Strong knowledge of ICH GCP and regulatory requirements.
• Proficient computer skills and data interpretation ability.
• Excellent written and verbal communication; good negotiation skills.

Responsibilities

• Perform routine site visits (pre-study, initiation, interim, closeout) independently.
• Manage sites through regular contact to ensure enrollment and protocol compliance.
• Review CRFs, generate queries, and resolve data issues per guidelines.
• Identify risks and training opportunities for site personnel.
• Prepare CAPA plans and follow up until resolution.
• Assist with EC submissions, document translation, and supervisor tasks.
• Negotiate study budgets and assist with site contracts.
• Administer site payments per project instructions.

Skills

ICH GCP

Trial monitoring

Regulatory knowledge

Computer skills

Data interpretation

Communication

Interpersonal skills

Independence

Matrix environment

Driver's license

Education

University degree in life sciences

Nursing or healthcare degree

Healthcare-related education

Job description

Location: Remote

Optimapharm is a mid-sized, global Contract Research Organisation (CRO) turning science into hope through agile, patient-focused clinical development. We specialise in Phase I–IV clinical studies, delivering Full-Service and Functional Service Provision (FSP) solutions that help sponsors move faster and execute with confidence.

With operations in 40+ countries and 2x the patient reach of the average mid-sized CRO, we enable accelerated regulatory pathways, faster study start-up, and access to diverse patient populations worldwide. At Optimapharm, you’ll contribute to meaningful clinical research while growing your career in a dynamic, people‑focused, global environment.

As we expand our US Clinical Operations team, we're searching for a CRA II/III who is motivated by quality, driven by purpose, and eager to contribute to innovative clinical research that changes lives.

Joining Optimapharm means more than taking on your next role - it's an opportunity to build a long-term career with a global CRO that values growth, development, and excellence. Our structured career pathway provides clear progression and recognition of your expertise: CRA I - CRA II - CRA III - Senior CRA.

Here, your dedication is rewarded with meaningful growth opportunities, exposure to diverse studies, and the support needed to reach your full potential.

What do we offer?

• Working in a successful company that’s growing and developing every day
• Being part of a clinical research team that transforms science into hope for patients
• International projects and professional growth
• Company that supports life balance
• Company with healthy culture
• Working with a highly experienced team of clinical research professionals
• Competitive salary
• Competitive PTO entitlement
• Health insurance, including vision and dental plans, to meet your and your family's needs
• Comprehensive pension plan to maximize savings and prepare confidently for the future
• Employee engagement programs
• Well‑being initiatives
• Training and development program
• Fast‑paced career path progression

Who are we looking for?

Qualifications and Experience

• University degree, preferably in medical or life sciences; nursing education or other relevant healthcare college degree
• At least 2 years of independent clinical trial monitoring experience
• High level of knowledge of ICH GCP Guidelines, knowledge of regulatory requirements and a strong interest in clinical research
• Computer proficiency is mandatory
• Ability to read, analyze, and interpret common scientific and technical journals
• Excellent verbal and written communication skills
• Very good interpersonal and negotiation skills
• Ability to work independently, pro‑active
• Affinity to work effectively and efficiently in a matrix environment
• A current, valid driver’s license

Your responsibilities

• Perform routine site visits independently, including pre‑study, initiation, interim monitoring and closeout visits
• Manage assigned sites by regular contact with site personnel to ensure site compliance, adequate enrolment and understanding of study requirements
• Independently perform CRF review; query generation and resolution against established data review guidelines or data management systems as applicable
• Identifying and escalating potential risks and identifying retraining opportunities for site personnel
• Preparation of corrective and preventive (CAPA) plans for issues identified during monitoring activities and pro‑active follow of each, individual CAPA until timely resolution
• Preparation of documents required for EC submissions and notifications, translation of study‑related documents (where applicable), and other tasks as instructed by the supervisor
• Independently negotiate study budgets with potential investigators/institutions and assist with the execution of site contracts as applicable
• Administration of site payments in accordance with relevant project instructions

By joining our fast‑growing and prosperous team, you will have an excellent opportunity for further personal growth and career development.

If you would be interested in joining the Optimapharm team, please send your CV and note that only shortlisted candidates who meet the requirements will be contacted for the further selection process.

Compensation is competitive and final offers will reflect each candidate’s experience, skills, and qualifications.

Disclaimer: Unsolicited CVs sent to Optimapharm (Talent Acquisition Team, Hiring Managers or any other OPT employee) by recruitment agencies will not be considered for this role. Optimapharm follows a direct sourcing strategy and collaborates exclusively with selected recruitment partners when external support is required.