Clinical Research Associate (CRA)
KlinEra Global Services INC is actively recruiting for an experienced Clinical Research Associate to work as an integral part of our global study team
Monitoring and Documentation Activities:
- Oversee clinical trial activities at investigational sites (will require travel to investigational sites).
- Conduct and write accurate visit reports in accordance with SOPs and GCP, including pre-study, site initiation, routine monitoring, and close-out visits.
- Interact with and guide study investigators and study coordinators in conducting clinical trials in accordance with study protocols.
- Ensure data entered in the CRFs (paper or electronic) by investigational sites in a timely manner and verify that data is consistent with patient clinical notes, known as source data/document verification (SDV).
- Collaborate with data management as appropriate, to obtain clean database, resolve queries and conduct or participate in data reviews (both internally and with sponsor), identifying and communicating trends or erroneous data.
- Monitor site’s completion of action items between visits.
- Training to be imparted to site personnel during Initiation visits and on an ongoing basis during the conduct of trial.
- Coordinate with vendors (e.g. central laboratory, e-diaries, Investigational medicinal product warehouse, etc.)
- Prepare for audits and inspections.
- Participate in internal TMF reviews, as needed.
- Review informed consent forms.
- Review of protocols, investigator brochures on compliance with applicable regulations and CRFs in development.
- Prepare submissions to Institutional Review Board (IRB) / Ethics Committees (ECs) and Competent Authorities (CAs)/Food and Drug Administration (FDA) and assist in administrative tasks for submissions.
- Prepare confidentiality agreements and complete templates of clinical trial/investigator agreements.
- Prepare annual trial progress reports for IRBs/ECs and CAs/FDA under supervision.
- (Assist in) reporting Serious Adverse Event to Sponsor, IRBs/ECs, CAs/FDA and investigators.
- Perform submissions to Institutional Review Board (IRB) / Ethics Committees (ECs) and Competent Authorities (CAs)/Food and Drug Administration (FDA) and follow up until approval is obtained.
- Participate in project meetings and investigator meetings and write minutes.
- Prepare annual trial progress reports for IRBs/ECs and CAs/FDA.
- Report Serious Adverse Events to Sponsor, IRBs/ECs, CAs/FDA and investigators.
- Prepare clinical trial agreements and discuss/negotiate between site and Sponsor.
QUALIFICATIONS & ATTRIBUTES:
- Bachelor’s Degree in Life Sciences, Pharmacy, Nursing or related field of study and/or equivalent experience
- Minimum of 2 years’ experience in investigator site management, including conducting monitoring visits, from either a pharmaceutical company or a CRO environment
- Experience across a wide range of clinical indications / therapeutic areas like Infectious Diseases, Cardiovascular, Endocrinology, Gastroenterology, Rheumatology, Respiratory, Dermatology and Oncology.
- A working knowledge of drug development process, ICH-GCP guidelines and local and international regulatory requirements is essential.
- Excellent oral and written communication skills is a must
- Experience in working with global operational teams and the global delivery model across time zones / geographies
- Requires up to 65% of travel across sites in US