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About the Role

As a Clinical Research Associate (Level II), you will perform and coordinate all aspects of the clinical monitoring and site management process. You will conduct remote or on-site visits to assess protocol and regulatory compliance, manage required documentation, and ensure trial adherence to guidelines 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, applying root cause analysis (RCA), critical thinking, and problem-solving skills to identify site processes failures and corrective/preventive actions.
Ensures data accuracy through SDR, SDV, and CRF review as applicable through 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, issue resolution, and timely data recording.
Conducts monitoring tasks in accordance with the approved monitoring plan.
Participates in the investigator payment process.
Ensures shared responsibility with other project team members on issues/findings resolution.
Investigates and follows up on findings as applicable.
Participates in investigator meetings as necessary.
Identifies 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 Clinical Team Manager (CTM) as required.
Ensures study systems are updated per agreed study conventions (e.g., Clinical Trial Management System).
Facilitates effective communication between investigative sites, the client company, and the PPD project team 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.
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 year as a clinical research monitor) or completion of PPD Drug Development Fellowship.
Valid driver's license where applicable.
An equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Skills

Proven clinical monitoring skills
Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
Demonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documents
Well-developed critical thinking skills, including critical mindset, in-depth investigation for appropriate root cause analysis and problem solving
Ability to manage Risk Based Monitoring concepts and processes
Good oral and written communication skills, with the ability to communicate effectively with medical personnel
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
Effective interpersonal skills
Attention to detail
Ability to remain flexible and adaptable in a wide range of scenarios
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
Good presentation skills

Location

Office

Work Type

Standard (Mon-Fri)
Office/laboratory/clinical/and/or home office environment
Frequent drives to site locations
Frequent travel, generally 60-80% but more for some individuals
May also include extended overnight stays

Experience Level

Level II

Education Level

Bachelor's degree in a life sciences related field
Registered Nursing certification
Equivalent and relevant formal academic / vocational qualification

Salary/Compensations

$75,000.00–$125,000.00

About the Company

Successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.