Description :

1. Assisted in managing clinical trial subjects and coordinated activities under the guidance of a Clinical Trial Specialist II.
2. Executed day-to-day operations of complex Phase I-IV clinical research protocols, ensuring compliance with GCP and regulatory requirements.
3. Led cross-functional study teams, collaborating with vendors to optimize trial execution.
4. Liaised with preclinical, pharmaceutical, safety, and regulatory teams to ensure accurate coordination of clinical studies.
5. Reviewed patient eligibility criteria and conducted a second check for trial inclusion/exclusion requirements.
6. Coordinated and attended monitoring and closeout visits, ensuring all trial activities were documented.
7. Maintained informed consent records throughout the study duration for compliance and audit readiness.

Experience

0-2 Years

Level

Entry Level

Education

B.S. Biology

Description :

1. Oversaw the review and management of Site Essential Documents during study start-up, maintenance, and close-out.
2. Created and managed study documents including consent forms, site instructions, and operational manuals.
3. Ensured accurate documentation in the CTMS and provided comprehensive support to the clinical team.
4. Monitored patient status and data integrity throughout the study lifecycle at investigative sites.
5. Reviewed and approved trip reports, tracking site performance and metrics effectively.
6. Conducted and facilitated Site Initiation Visits to ensure compliance and readiness.
7. Collaborated with cross-functional teams to address and resolve queries related to trial data.

Experience

2-5 Years

Level

Junior

Education

B.S. Biology

Description :

1. Managed clinical trial operations, ensuring compliance with protocols and regulations.
2. Coordinated site selection, initiation, and monitoring for clinical studies.
3. Developed and maintained study documentation, including protocols and informed consent forms.
4. Collaborated with cross-functional teams to ensure timely project delivery.
5. Maintained and reconciled the Trial Master File, ensuring data accuracy.
6. Provided logistical support by managing tracking systems and preparing necessary materials.
7. Conducted site visits to monitor patient recruitment and data integrity.

Experience

5-7 Years

Level

Senior

Education

B.S. Biology

Description :

1. Prepared and submitted IRB applications, ensuring compliance until final approval.
2. Conducted site feasibility assessments and pre-qualification evaluations.
3. Maintained professional relationships with external stakeholders and clinical sites.
4. Negotiated resolutions with sites to address challenges and improve trial outcomes.
5. Operated autonomously while proactively seeking guidance when necessary.
6. Managed biospecimen logistics for oncology clinical trials, ensuring compliance and quality.
7. Contributed to the design and planning phases of clinical trials, enhancing operational efficiency.

Experience

7-10 Years

Level

Management

Education

MSc CR

Description :

1. Trained and supported site staff on study protocols and procedures.
2. Reviewed and approved study-related materials, including CRFs and manuals.
3. Collaborated with medical advisors to formulate publication strategies for key therapeutic areas including oncology and immunology.
4. Ensured adherence to Good Clinical Practice (GCP) guidelines throughout trials.
5. Participated in phase III and IV research projects, maintaining a comprehensive overview of ongoing clinical trials.
6. Independently negotiated clinical site agreements, including PREDICT Agreements and Letters of Indemnification.
7. Provided training at investigator meetings to enhance compliance and understanding of study protocols.

Experience

10+ Years

Level

Executive

Education

M.S. CR

Description :

1. Oversaw the execution of clinical trial protocols, ensuring adherence to regulatory standards and timelines.
2. Managed training programs for clinical staff, enhancing their understanding of study protocols and compliance.
3. Collaborated with cross-functional teams to develop and refine study protocols and operational guidelines.
4. Prepared and submitted regulatory documents to ensure compliance with local and international standards.
5. Analyzed trial data to monitor progress and identify areas for improvement.
6. Acted as the primary contact for regulatory agencies and ethics committees.
7. Facilitated communication between study sites and internal stakeholders to ensure timely project updates.

Experience

5-7 Years

Level

Consultant

Education

M.S. CR

Description :

1. Maintained strong relationships with study teams, sites, and sponsors to facilitate effective communication.
2. Demonstrated comprehensive knowledge of FDA regulations and ICH-GCP guidelines throughout study phases.
3. Assisted in developing and updating study-specific manuals while training site personnel on procedures.
4. Regularly communicated with management regarding project progress and prioritization of tasks.
5. Conducted site initiation, monitoring, and close-out visits, ensuring compliance with protocols.
6. Coordinated with third-party vendors to manage metrics, accruals, and process implementation.
7. Delivered clinical and biomarker data to support corporate objectives and enhance trial results.

Experience

0-2 Years

Level

Fresher

Education

B.S. in Biology

Description :

1. Maintained study-level timelines and ensured accurate data entry into clinical trial management systems.
2. Created and managed the Trial Master File, participating in TMF audits to guarantee compliance.
3. Prepared comprehensive site manuals and project-specific documents to support study teams.
4. Managed project-specific access for internal teams and external sites to facilitate smooth operations.
5. Coordinated team meetings, documenting minutes and tracking action items for accountability.
6. Assisted in vendor management alongside the Clinical Trial Manager, tracking samples and supplies.
7. Updated dashboards and status trackers to provide stakeholders with current trial progress.

Experience

2-5 Years

Level

Junior

Education

M.S. CR

Description :

1. Collaborated with cross-functional teams to ensure efficient execution of clinical trial operations.
2. Balanced assignments and workloads, identifying Subject Matter Experts to support onboarding and training.
3. Provided guidance during internal audits and external inspections, enhancing team compliance.
4. Supported adherence to ICH-GCP guidelines and standard operating procedures for inspection readiness.
5. Contributed to key projects that enabled successful execution of clinical programs.
6. Partnered with Clinical Trial Managers to deliver tasks with high accuracy and timeliness.
7. Maintained project-specific status reports, ensuring communication with sponsors and study sites.

Experience

5-7 Years

Level

Senior

Education

B.Sc. Clinical Research

Description :

1. Managed end-to-end clinical trial operations, ensuring adherence to regulatory requirements and timelines.
2. Developed and executed training programs to enhance team competency in clinical trial processes.
3. Oversaw resource allocation, optimizing staff assignments and trial budgets for efficiency.
4. Established best practices forums to facilitate knowledge sharing and process improvement.
5. Monitored trial progress, providing guidance and support to ensure successful execution of study protocols.
6. Acted as the primary liaison for stakeholder communication, resolving issues and negotiating solutions.
7. Conducted regular reviews of ICH-GCP compliance, ensuring team alignment with industry standards.

Experience

7-10 Years

Level

Management

Education

M.S. Clinical Research