Clinical Research Associate

CRO Strategies; Boston (MA); Remote; USD 125,000 - 150,000; Full time

Job summary

An established industry player is looking for a Clinical Research Associate (CRA) with a strong background in erectile dysfunction clinical trials. This exciting opportunity involves monitoring studies, ensuring compliance with regulatory guidelines, and supporting high-quality data collection. The ideal candidate will have a minimum of 3 years of CRA experience and a Bachelor's degree in life sciences or nursing. Join a dynamic team where your expertise will contribute to critical clinical research efforts in a supportive and innovative environment, making a real impact in the field of men's health.

Qualifications

• 3+ years of CRA experience, with 1+ year in erectile dysfunction clinical trials.
• Strong knowledge of ICH-GCP guidelines and FDA regulations.

Responsibilities

• Conduct site selection, initiation, monitoring, and close-out visits.
• Ensure adherence to FDA, ICH-GCP, and site-specific regulations.

Skills

ICH-GCP guidelines

FDA regulations

Site management

Monitoring abilities

Communication skills

Problem-solving skills

Education

Bachelor's degree in life sciences

Bachelor's degree in nursing

Tools

eTMFs

Job description

This range is provided by CRO Strategies. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$85.00/hr - $100.00/hr

Clinical Research Associate (CRA) – Erectile Dysfunction (ED) Clinical Trials

Location: Remote with site travel as needed - MUST BE BOSTON, MA BASED

Employment Type: Contract

Overview:

We are seeking an experienced Clinical Research Associate (CRA) with a strong background in erectile dysfunction (ED) clinical trials. The ideal candidate will have direct experience monitoring studies related to ED treatments, ensuring compliance with regulatory guidelines, and supporting high-quality data collection.

Key Responsibilities:

1. Site Monitoring & Management: Conduct site selection, initiation, routine monitoring, and close-out visits to ensure compliance with study protocols and regulatory requirements.
2. Regulatory Compliance: Ensure adherence to FDA, ICH-GCP, and site-specific regulations.
3. Data Review & Quality Assurance: Verify case report forms (CRFs), source documents, and electronic trial master files (eTMFs) for accuracy and completeness.
4. Investigator & Site Support: Provide training and ongoing guidance to site staff on study procedures, protocol adherence, and regulatory compliance.
5. Issue Identification & Resolution: Address site-level challenges such as patient enrollment, protocol deviations, and data inconsistencies.
6. Stakeholder Communication: Serve as a key liaison between sponsors, investigators, and internal study teams to ensure seamless study execution.

Qualifications:

1. Experience: Minimum 3+ years of CRA experience, with at least 1+ year in erectile dysfunction (ED) clinical trials.
2. Education: Bachelor's degree in life sciences, nursing, or a related field required.
3. Skills:
4. Strong knowledge of ICH-GCP guidelines, FDA regulations, and ED-specific study protocols
5. Excellent site management and monitoring abilities
6. Ability to work independently and manage multiple sites
7. Strong communication and problem-solving skills
8. Travel: Willingness to travel as required for site visits.

Preferred Qualifications:

1. Experience in urology, men’s health, or sexual dysfunction studies.
2. Prior work with CROs, sponsors, or high-volume research sites.
3. Certification (e.g., ACRP, SOCRA) is a plus.

Seniority level

Mid-Senior level

Employment type

Contract

Job function

Research, Analyst, and Information Technology

Industries

Pharmaceutical Manufacturing