Clinical Research Associate Ii

3+ years

$66,000 – $80,000 annually

Remote

10 Sept. 18, 2024

Job Description

Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Position: Clinical Research Associate II
Salary: $66,000 - $80,000
Location: Remote

We are seeking a Clinical Research Associate II to join our team! If you have a background in clinical research, enjoy traveling, and can adapt to change with ease, we want to hear from you. Are you someone who quickly builds strong relationships and proactively identifies problems to develop effective solutions? If so, keep reading!

Key Responsibilities:

Travel to clinical trial sites to ensure compliance with protocols, federal regulations, and ICH-GCP (Good Clinical Practice) guidelines.
Conduct various monitoring visits, including:
- Site Evaluation Visits
- Site Initiation Visits
- Routine Monitoring Visits
- Close-out Visits
Oversee drug accountability, storage, and disposition at investigative sites.
Collect and maintain investigator regulatory documents.
Conduct Site Endpoint Evaluation Visits as required by contract.
Maintain required records for monitoring activities and regulatory documents per CPC requirements.
Assist in producing study materials, including Case Report Forms, Study Procedure Manuals, and source documents.
Aid in selecting qualified sites and investigators for research protocols.
Develop and present materials for investigator meetings and sponsor/CRO training.
Provide training to other CRAs and staff at selected research sites.

Qualifications:

Nursing or bachelor’s degree preferred, but not required.
Minimum of three years of experience in clinical trials research, including at least one year as a CRA.
Demonstrated mastery of CRA I responsibilities.
Thorough knowledge of Good Clinical Practice guidelines and applicable FDA and ICH regulations for conducting clinical drug trials.
Understanding of the drug development process.
Intermediate proficiency in MS Office; experience with EDC and CTMS is strongly preferred.
Excellent interpersonal communication skills, organizational skills, and attention to detail.
Ability to complete tasks accurately and in a timely manner with minimal supervision.
Capacity to prioritize tasks effectively and manage conflicts to resolve issues.
Willingness to travel up to 60%.

Note: Applicants will be required to pass a background and education verification check.

Targeted Compensation: $66,000 – $80,000 annually
Application Deadline: October 1, 2024

About CPC:

CPC is an academic research organization that provides full-service clinical trial design, oversight, and management, with rapid access to Key Opinion Leaders across various therapeutic areas. With over 30 years of experience, we have supported over 150 clinical trials in multiple indications, particularly in cardiovascular health, wound healing, and diabetes.

CPC Community Health focuses on innovative programs that empower communities to promote active and healthy lifestyles. For more information, visit CPC Community Health.

CPC Offers:

Comprehensive benefits package (medical, dental, vision, life insurance, STD, LTD, etc.)
Matching 401(k) plan (dollar for dollar up to 4% of eligible compensation, fully vested immediately)
11 paid holidays
15-25 vacation days based on years of service
Paid sick time (2.67 hours accrued bi-weekly, up to a maximum of 80 hours)
In-suite exercise and relaxation room
Monthly team-building events and activities
Flexible and remote work schedules

Equal Opportunity Employer:

CPC provides equal employment opportunities (EEO) to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, military status, genetic information, age, or any other status protected by applicable law. We are committed to ensuring all qualified applicants have equal opportunity and that selection decisions are based on job-related factors.

If you require assistance due to a disability, please email our Human Resources team at careers@cpcmed.org.

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Clinical Research Associate Ii

Job Description

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