Intern Clinical Research Associate
Intern Clinical Research Associate
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Job Description
Job Description
- With support acts as primary site contact and site manager throughout all phases of a clinical research study taking responsibility of allocated sites.
- Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
- Performs clinical study site management/monitoring activities in compliance with ICH-GCP Sponsor SOPs Local Laws & Regulations Protocol Site Monitoring Plan and associated documents.
- Gains an in-depth understanding of the study protocol and related procedures.
- Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.
- Participates & provides inputs on site selection and validation activities.
- Performs remote and on-site monitoring & oversight activities using various tools to ensure:
- Data generated at site are complete accurate and unbiased
- Subjects right safety and well-being are protected
- Conducts site visits including but not limited to validation visits initiation visits monitoring visits close-out visits and records clear comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
- Collects reviews and monitors required regulatory documentation for study start-up study maintenance and study close-out.
- Communicates with Investigators and site staff on issues related to protocol conduct recruitment retention protocol deviations regulatory documentation site audits/inspections and overall site performance.
- Identifies assesses and resolves site performance quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRM PLM and RCPM.
- Manages and maintains information and documentation in CTMS eTMF and various other systems as appropriate and per timelines.
COMPETENCY EXPECTATIONS:
- Fluent in Local Languages and English (verbal and written) and excellent communication skills including the ability to understand technical information. Developing ability to present technical information with support.
- Good understanding and working knowledge of clinical research phases of clinical trials current GCP/ICH & country clinical research law & guidelines.
- Good understanding of Global Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
- Hands on knowledge of Good Documentation Practices
- Developing skills in Site Management including management of site performance and patient recruitment
- Developing level of monitoring skill and independent professional judgment.
- Good IT skills
- The intern will be trained online and well as on- the -job to appreciate the role of: clinical research associate and clinical trial coordinator.
Behavioural Competency Expectations:
- Effective time management organizational and interpersonal skills conflict management
- Able to work with other experienced research professions to develop skills across multiple protocols sites and therapy areas.
- High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment with support from Line Manager
- Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
- Demonstrates commitment to Customer focus.
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Search Firm Representatives Please Read Carefully
Merck & Co. Inc. Rahway NJ USA also known as Merck Sharp & Dohme LLC Rahway NJ USA does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place introductions are position specific. Please no phone calls or emails.
Employee Status:
Intern/Co-op (Fixed Term)Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
HybridShift:
Valid Driving License:
Hazardous Material(s):
Required Skills:
Adaptability Adaptability Clinical IT Clinical Research Clinical Site Management Clinical Study Design Clinical Testing Clinical Trial Management Clinical Trials Analysis Clinical Trials Monitoring Clinical Trials Operations Clinical Trial Support Conflict Resolution Data Analysis Data Management Drug Development Research Early Clinical Development Global Clinical Studies Good Clinical Data Management Practice (GCDMP) ICH GCP Guidelines Interpersonal Relationships Management Process Medical Research Organizational Performance Management Regulatory Compliance 5 morePreferred Skills:
Job Posting End Date:
11/30/2025*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Required Experience:
IC
Employment Type
Full-Time
