Associate - Clinical Research (1-3 yrs)
ESEENTIAL FUNCTIONS, DUTIES, AND REPSONSIBILITIES:
1. Conduct of the Feasibility:
a) To understand and analyze the need and the timelines for the conduct of the feasibility as requested by Business Development (BD)/Internal Departments.
b) Reviews and understands the available study details like protocol, protocol synopsis for the conduct of the feasibility.
c) Identifies the potential investigators to be contacted for the conduct of the feasibility.
d) Attend the teleconferences with the Client/Global team as required
e) Prepares and obtains the signed Confidentiality Agreements as required.
f) Contacts potential investigators to discusses the study details with Investigators in brief providing critical information needed to obtain the feedback desired, to the assess the feasibility of the proposed study.
g) Prepares and reviews the feasibility questionnaire.
h) Prepares the correspondence to the site to send the study details, questionnaire and related matter to obtain the feedback as required.
i) Reviews, collates and analyses the feedback received from the Investigators and prepares the reports.
j) Forwards the report in detail to the feasibility requestor as desired.
k) Prepares the telephonic contact reports as desired.
l) Files the filled in questionnaire, relevant correspondence and related documents and updates the contact list.
m) Updates the Investigator's database on the regular basis.
n) Updates and maintains the soft copy of the feasibility folder on a ongoing basis as required.
o) Reports regularly to the relevant parties involved, informed about the status of the feasibility at all the stages.
p) Identifies issues and arranges for resolutions by relevant personnel.
2. Identification of New sites:
a) To proactively identify the new sites keeping in mind the business trend and the need for the new sites across therapeutic areas.
b) Performs the site visits for site evaluation as needed. Prepares internal site trip reports, recommending actions where appropriate and documents the decision of the site visit.
3. Investigator's Database- :
a) To help creating the database of the existing as well as new & potential investigators
b) To update and upgrade the Investigator's database.
4. Site Relationship :
- Identifies and records quality problems primarily pertaining to the conduct of the feasibility and site identification as well as site relationship. Suggests, initiates, recommends and/or provides solutions as appropriate.
- Participates in the investigator recruitment process. Performs site evaluation visits of potential investigators. Evaluates the capability of the site to successfully manage and conduct the clinical study. Collaborates with clinical operations to coordinate activities with the site in preparation for the initiation of the study.
- Obtains regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials. Works with site staff to obtain regulatory (IRB/IEC) approval of study specific documents. May be asked to develop protocol for collection studies for submission to Central IRB.
- May be asked to present updates for clinical site progress to sponsors, as needed.
- Ensures return of unused study materials to designated location or verifies destruction as required.
- Reviews the quality and integrity of the clinical data through (1) in house review of electronic CRF data, and (2) on-site source verification (as needed). Works with sites to resolve data queries.
- May review protocols, eCRFs, study manuals and other related documents, as requested by clinical operations.
- Serves as primary contact between iProcess and the investigator; coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested.
Performs study close-out visits per the study specific Clinical Monitoring Plan including site study file reconciliation, and data query resolution.
- Assists with, and attends, Investigator and Sponsor Meetings for assigned studies. Attends study-related, company, departmental, and external meetings, as required.
- Ensures internal and study-related trainings are completed per iProcess and/or study timelines; CTMS should always be current with the pertinent site updates/contacts.
- Ensures all study deliverables or site supplies are completed per iProcess and study timelines.
- Serves as mentor for junior CRAs and those new to the company and/or study. Performs other duties, as requested.
Knowledge, Skills And Abilities :
- Strong knowledge of clinical research process, including working knowledge of all functional areas of clinical trials and medical terminology. Experience in oncology or infectious disease required.
- Experience in monitoring and/or coordinating clinical trials or collection studies required.
- Excellent written and verbal communication skills to express complex ideas to study personnel at research and clinical institutions.
- Demonstrated ability to form strong functional relationships.
- Excellent presentation, organizational and interpersonal skills. Ability to interact with all levels of staff to coordinate/execute study activities.
- Ability to handle several priorities within multiple, complex trials.
- Ability to reason independently and recommend specific solutions in clinical settings.
- Ability to work independently, prioritize, and work within a matrix team environment. Ability to mentor other CRAs and co-monitor, as required.
- Knowledge of current GCP/ICH guidelines applicable to the conduct of clinical research.
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