Clinical Research Associate II/III - US

Optimapharm; Atlanta (GA); On-site; USD 70,000 - 110,000; Full time

Benefits offered by this job

Health insurance

Pension plan

Training & development

Well-being initiatives

PTO entitlement

Competitive salary

Job summary

Optimapharm is expanding its US Clinical Operations team and seeks a CRA II/III with a strong focus on quality and patient-centric clinical research. The role covers monitoring across Phase I–IV studies, regulatory compliance, and collaboration within a global, fast-growing CRO environment.

Responsibilities include site management, CRF reviews, CAPA planning, and budget negotiations. A university life sciences degree and 2+ years of monitoring experience are preferred.

Qualifications

• University degree in medical or life sciences, or nursing/healthcare background.
• Minimum 2 years of independent clinical trial monitoring experience.
• Strong knowledge of ICH GCP guidelines and regulatory requirements.
• Computer proficiency is mandatory.
• Ability to read, analyze and interpret scientific/technical journals.
• Excellent verbal and written communication skills.
• Very good interpersonal and negotiation skills.
• Ability to work independently in a matrix environment.
• Valid driver’s license.

Responsibilities

• Perform routine site visits independently (pre-study, initiation, interim monitoring, closeout).
• Manage assigned sites with regular contact to ensure compliance and enrolment.
• Independently perform CRF review and data query resolution.
• Identify risks and retraining opportunities for site personnel.
• Prepare CAPA plans and ensure timely resolution.
• Prepare documents for EC submissions and translate study documents (where applicable).
• Negotiate study budgets and assist with site contracts as applicable.
• Administer site payments per project instructions.

Skills

ICH GCP knowledge

Independent monitoring

Regulatory awareness

Verbal and written communication

Interpersonal skills

Matrix environment

Proactive

Driver's license

Reading scientific literature

Computer proficiency

Education

University degree in medical or life sciences

Nursing or healthcare degree

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.