Clinical Research Coordinator

Job Description

Description
Summary
Perform a variety of clinical procedures to collect, record, report and interpret data on patients enrolled and/or seeking enrollment in clinical studies according to the protocol, standard operating procedures (SOPs), and Good Clinical Practice (GCP). Assist with daily workload planning.

Responsibilities
Provide clinical research support to investigators to prepare for and execute assigned research studies, including:
Review study protocols, Case Report Forms (CRFs), other study-specific documents, and electronic data capture systems used to record clinical research data
Attend all relevant study meetings
Collect and submit regulatory/ethics documentation as required by the FDA and other regulatory bodies governing the conduct of clinical research
Recruit and screen patients for clinical trials and maintain subject screening logs
Orient research subjects to the study, including the purpose of the study, procedures, and protocol issues such as timelines for visits
Design and maintain source documentation based on protocol requirements
Schedule and execute study visits and perform study procedures
Collect, record and maintain research subject study data according to study protocol and SOPs, preserving quality control for content, accuracy and completeness
Handle lab testing and analysis, including preparation of specimen collection tubes and lab logistics
Monitor subject safety and report adverse reactions to appropriate medical personnel
Correspond with research subjects and troubleshoot study-related questions or issues
Participate in huddles to confirm daily study tasks are assigned to team members and are executed to the expected standards
Assist with study data quality checking and query resolution
Perform a variety of complex clinical research procedures including but not limited to ECG, sample collection, spirometry, vital signs, dose verification, cannulation and cardiac telemetry monitoring
Record, report and interpret study findings appropriately to develop a study-specific database
Assist investigator in verifying that research study objectives are met on time, within budget and according to applicable protocol requirements, clinical research regulations and quality standards
Provide training to new investigator site staff members on study-specific topics and requirements
Assist in maintaining adherence to investigator site staff training requirements by auditing and maintaining training records
Prepare for and attend study monitoring visits, study audits, and regulatory inspections with clinical research regulatory agencies
Assist research site with coverage planning related to staffing and scheduling for research projects

Required Knowledge, Skills and Abilities
Knowledge of clinical trials
In-depth knowledge of departmental, protocol and study-specific operating procedures, consent forms, and study schedules
Knowledge of medical terminology
Skilled in using MS Windows and Office applications such as Access, Outlook, Excel, and Word
Excellent interpersonal skills
Ability to pay close attention to detail
Ability to establish and maintain effective working relationships with coworkers, managers and clients

Minimum Required Education and Experience
High school diploma (A BS would be a plus) or educational equivalent and relevant work experience in a clinical environment or medical setting; or equivalent combination of education, training and experience
Applicable certifications and licenses as required by the company, country, state, and/or other regulatory bodies

Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.

Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it's from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.

---