Clinical Research Associate I - United States

About the role

Join a global team that has supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last five years. As a Clinical Research Associate I, you’ll perform and coordinate different aspects of the clinical monitoring and site management process, conducting 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 (e.g., FSO, FSP, Government) and ensure trials are conducted in accordance with approved protocols, 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.

Responsibilities

• Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking, and problem-solving skills to identify site process failures and implement corrective/preventive actions to bring the site into compliance and decrease risks.
• Ensures data accuracy through source data review (SDR), source data verification (SDV), and case report form (CRF) review via on-site and remote monitoring activities.
• Assesses 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 follows all issues through to resolution.
• Maintains regular contact between monitoring visits with investigative sites to confirm protocol adherence, resolution of previously identified issues, and timely data recording.
• Conducts monitoring tasks in accordance with the approved monitoring plan.
• Participates in the investigator payment process.
• Shares responsibility with other project team members on issues/findings resolution; investigates and follows up on findings as applicable.
• Participates in investigator meetings as necessary.
• May help identify potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites.
• Initiates clinical trial sites according to relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted.
• Performs trial close-out and retrieval of trial materials.
• Ensures required essential documents are complete and in place according to ICH-GCP and applicable regulations.
• Conducts on-site file reviews as per project specifications.
• Provides trial status tracking and progress update reports to the team as required.
• Ensures study systems are complete, accurate, and updated per agreed study conventions (e.g., Clinical Trial Management System).
• Facilitates effective communication between investigative sites, the client company, and internal project teams through written, oral, and/or electronic contacts.
• Responds to company, client, and applicable regulatory requirements/audits/inspections.
• Maintains and completes administrative tasks such as expense reports and timesheets in a timely manner.
• Contributes to the project team by assisting in the preparation of project publications/tools and sharing ideas/suggestions with team members.
• Contributes to other project work and initiatives for process improvement, as required.

Requirements

• Bachelor’s degree in a life sciences-related field or a Registered Nursing certification or equivalent and relevant formal academic/vocational qualification.
• Minimal clinical monitoring experience (comparable to 2 years) in a clinical environment where experience is gained in clinical trials, medical terminology, medical research, clinical research, or healthcare; or experience in a health sciences field with formal training in medical terminology and anatomy may be considered.
• Valid driver’s license where applicable.
• Must be legally authorized to work in the United States without sponsorship.
• Must be able to pass a comprehensive background check, including a drug screening.
• Candidates ideally live within 60 miles of a major airport hub.
• In some cases, an equivalency consisting of a combination of appropriate education, training, and/or directly related experience will be considered sufficient.

Skills

• Basic medical/therapeutic area knowledge and understanding of medical terminology.
• Ability to attain and maintain a working knowledge of ICH GCPs and applicable regulations and procedural documents.
• Good oral and written communication skills, with the ability to communicate effectively with medical personnel.
• Good interpersonal skills and ability to maintain customer focus through good listening skills, attention to detail, and the ability to perceive customers’ underlying issues.
• Good organizational and time management skills.
• Ability to remain flexible and adaptable in a wide range of scenarios.
• Well-developed critical thinking skills, including a critical mindset, in-depth investigation for appropriate root cause analysis, and problem-solving.
• Ability to manage Risk-Based Monitoring concepts and processes.
• Ability to work in a team or independently as required.
• Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software.
• Good English language and grammar skills.

Environmental Conditions

• 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 may exceed this for some individuals, including 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.

Pay

The salary pay range for this position (CRA Level I) based in North Carolina is $75,000.00–$89,000.00. 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.

Benefits

• A choice of national medical, dental, and vision plans, 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 a 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.