Clinical Research Associate
2 days ago
**DESCRIPTION**
The Clinical Research Associate (CRA) - Site Manager will coordinate clinical studies and be responsible for all major stages of study development, execution, monitoring, and close-out.
**RESPONSIBILITIES**:
- Drafts materials including informed consents, case report forms (CRFs), CRF completion guidelines, and technical instructions.
- Carries out clinical site qualification, contract negotiation, IRB/ethical committee submissions, protocol initiation, site monitoring, and site close-out
- Coordinates and manages the activities of investigative sites to ensure compliance with study protocol requirements
- Ensures preparation, collection and distribution of trial master file (TMF) documents and maintenance of regulatory files at investigative site
- Conducts clinical site and data monitoring and completes monitoring visit reports
- Supports study supply, biospecimen delivery, and biospecimen testing logistics
- Evaluates clinical data and coordinates data query resolutions
- Supports internal departmental quality compliance
- Prepares progress reports and performance metrics
- Complete appropriate therapeutic, protocol and clinical research training to perform job duties.
- Independently administer protocol and related study training to assigned sites and establishes regular lines of communication with sites to manage ongoing project expectations and issues.
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to CTL and/or line manager.
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrolment, Case Report Form (CRF) completion and submission, and data query generation and resolution.
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation.
- Required travel to investigative sites up to 10%
**REQUIRED KNOWLEDGE, SKILLS AND ABILITIES**:
- Clinical Research Competencies:
- Clinical site management and monitoring experience
- Advanced knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines
- Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer
- Strong written and verbal communication skills including good command of English language
- Excellent organizational and problem-solving skills
- Effective time management skills
- Ability to manage competing priorities
- Ability to establish and maintain effective working relationships with co-workers, managers and clients
**MINIMUM REQUIRED EDUCATION AND EXPERIENCE**
Degree or currently enrolled in bachelor's degree program in health care or other related discipline.; or equivalent combination of education, training and experience
**PHYSICAL REQUIREMENTS**:
- Extensive use of telephone and face-to-face communication requiring accurate perception of speech
- Extensive use of keyboard requiring repetitive motion of fingers
- Regular sitting for extended periods of time
- Frequent travel to sites, primarily domestic, may include international travel
-
Senior / Clinical Research Coordinator
1 week ago
Singapore Consortium for Clinical Research and Innovation Singapore Full timeOverview The Consortium for Clinical Research and Innovation, Singapore (CRIS) brings together seven national R&D, clinical translation and service programmes to advance clinical research and innovation for Singapore, and establish important capabilities for a future-ready healthcare system. Singapore Clinical Research Institute (SCRI)Advanced Cell Therapy...
-
Manager, Clinical Research Networks
2 hours ago
Singapore Consortium for Clinical Research and Innovation Singapore Full time**Job Title**Manager, Clinical Research Networks (3 year contract) **About SCRI** The Singapore Clinical Research Institute (SCRI) is the national coordinating body (NCB) for clinical trials with a vision to establish Singapore as a regional thought leader in clinical research. This is accomplished through the deployment of innovative technologies...
-
Clinical Research Associate 2
1 week ago
Singapore PHARMACEUTICAL RESEARCH ASSOCIATES SINGAPORE PTE. LTD. Full timeRole: Full time position Title: Clinical Research Associate 2 Key requirement: to possess experience as a CRA Annual salary bandwidth range (guideline only, to be determined post interview assessent): SGD 60,000 - 70,000 Location: Singapore, office based Education requirements: Bachelor Degree in Life Sciences or equivalent As a Clinical Research...
-
Associate Clinical Research Coordinator
2 weeks ago
Singapore Singapore General Hospital Full timeAssociate Clinical Research Coordinator / Clinical Research Coordinator Job Description You will provide research support service for clinical research, in accordance to the applicable regulatory, Good Clinical Practice and protocol requirements. You will work closely with the Principal Investigators (PIs), to assist them with organisation of study...
-
Clinical Research Associate
2 days ago
Singapore MSD Full time**Clinical Research Associates** - Opportunity to** be a part of our Global Clinical Research organization!**: - **Based in Singapore**, the regional hub for Asia Pacific (AP) and top-ranked biopharmaceutical company on The Straits Times and Statista’s list of Best Employers in Singapore for two consecutive years (2020, 2021). - Join the **premier...
-
Clinical Research Associate
2 hours ago
Singapore Medpace, Inc. Full timeJob Summary: The Clinical Research Associate at Medpace is offering the unique opportunity to have an exciting career in the research of drug and medical device development while making a difference in the lives of those around them. For those with medical and/or health/life science interest and background who want to explore the research field and be part...
-
Singapore EISAI CLINICAL RESEARCH SINGAPORE PTE. LTD. Full time**Job Role** Responsible for ensuring that the assigned regional/global project(s) meet the short **Primary Responsibilities** - Acts as the Regional Lead for the designated regional/global studies and assists the Manager/Senior Manager, Clinical Operations in the daily operational matters related to the execution, management and monitoring of the trials,...
-
Singapore SingHealth Full timePress Tab to Move to Skip to Content Link Select how often (in days) to receive an alert: Senior Lead Clinical Research Associate, Research Compliance Management Job Category: Allied Health Professional Posting Date: 9 May 2025We are seeking a Senior Lead Clinical Research Associate to oversee clinical research compliance management across SingHealth...
-
Singapore Singapore General Hospital Full timeOverview We are seeking a Senior Lead Clinical Research Associate to oversee clinical research compliance management across SingHealth institutions. In this role, you will ensure adherence to regulatory requirements including the Human Biomedical Research Act, Health Products Act, International Council for Harmonisation - Good Clinical Practice guidelines...
-
Clinical Research Associate Trainee
2 days ago
Singapore UNIQ SEARCH ASIA PRIVATE LIMITED Full time**PURPOSE** Engage in company training program to gain knowledge and skills required to independently conduct clinical monitoring visits in accordance with study protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements. **RESPONSIBILITIES**: - Complete appropriate therapeutic, protocol and clinical research...
